Pfizer Strikes Back Spring 2007 Pharma on the back foot as … Europe_Mar 07.pdf · 2007-03-29 ·...

The pharmaceutical industry is on thedefensive over its prices in marketsaround the world, and could have itsfuture growth stunted if it fails to winsome key battles in the near future.

Developments in the last few weeks inthe US, Europe and Asia are threateningto undermine the industry’s bid to re-establish strong growth.

In the US, the world’s biggest and mostprofitable market for the industry, leadingpharma executives say it could be only amatter of time before it adopts stringentprice cuts similar to those used in manyEuropean countries.

In the UK, a competition watchdog hasdeclared that the health service is payingmillions of pounds too much for its med-icines. It has recommended the scrappingof the UK’s current free pricing system,widely regarded as the most pharma-friendly in Europe.

Meanwhile, another key battle overprices and patents is soon to be decided inIndia, one of the key emerging marketsfor pharma. Novartis has mounted a legalchallenge to plans by the Indian govern-ment to overturn the patent on its block-buster cancer drug Glivec.

The company says it is opposing a fla-grant abuse of its intellectual property, butcampaigners have condemned it, saying itwants to deny access to cheap medicinesto the most needy.

The industry is reliant on US sales tosupport profits and current global busi-ness models, and significant price cutsthere would hit earnings and force a fasterthan expected restructuring in the sector.

The European NightmareCharles Bouchard, Executive Director,European Government Affairs at MerckSharp & Dohme warned that the UScould soon catch the European disease.

“There’s no question that US legislatorsare looking at European models. There’sno doubt about it. There is a lot of politi-cal pressure to do this,” he explained atThe Economist pharmaceuticals confer-ence in London.

“Luckily, we are not seeing the worst ofthe European price-cuts in the US yet,”said Bouchard, but he added that the UScould be facing “the nightmare of theEuropean market”.

Pamela Santoni, Senior Principal atconsultants IMS Health said: “I have nodoubt that some big price-cuts are comingin the US – it’s just a matter of when andhow it occurs. It could take a lot of differ-ent forms – from capped price controls to

something where [the federal insuranceadministrators] the CMS begins to negoti-ate certain prices in certain therapeuticareas.”

Santoni warned that if neither the USnor Europe were willing to pay the pricefor ‘incremental’ innovation – how medi-cine has worked in most cases until now –then long-term improvement in treatmentcould be jeopardised.

The German government is currentlyconsidering whether to introduce ‘thera-peutic reference pricing’ whereby drugsfor the same condition are groupedtogether regardless of mechanism.

The industry says this would be anoth-er blow to the German industry. Despitehaving the highest prices in Europe, theGerman reference pricing system strong-ly discourages innovation and investment.

MSD’s Charles Bouchard said: “Ifthere had been therapeutic reference pric-ing where, for example, a statin is a statinis a statin, we would have missed out [onsome real therapeutic advances].”

Also addressing the Economist confer-ence, Paul Herrling, Head of CorporateResearch at Novartis said the company’sIndia patent battle was attracting hugemedia attention, and admitted it had beensurprised by the strength of opposition.

Glivec controversy“We didn’t expect quite such an uproar,but there you go,” he said, adding that a“misunderstanding somewhere” had been

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Pharma on the back foot asbattles over price heat up

Exodus? Merck Serono’s new HQ in Geneva. The company is one of three

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the most likely cause of the row.The battle over Glivec’s patent

could have far wider implications.Critics say if Novartis wins itscase, India’s generic manufactur-ers will no longer be able to supplycheap generics for poorer marketsworldwide, but Novarits deniesthis will happen.

Outlining his role in working ona number of vital, not-for-profitR&D projects with developingworld governments, Herrling saidrelationships in developing mar-kets were often very good.

Herrling said he regularly hasconversations with governmentsabout how to build up successfulpharma and biotech sectors, butmany have a long way to go inunderstanding just what it is thatthe industry requires.

“Many of these people are veryinexperienced in knowing what itreally takes [to nurture pharmaR&D], and when I show them howmuch it takes to invest in peopleand resources, they say ‘that’s notas quick as bottling up a medicineand shipping it out’.”

Novartis holds mini-symposiawith local scientists and its ownresearchers, a tactic Herrling sayshas proved very effective in gener-ating excitement about possibleinvestment and collaborations.

It has also brought a newdimension to reimbursement deci-sions in these countries. Citing onerecent conversation, Herrling said:“We said no Glivec [reimburse-ment], no research collaboration.And we got it.”

Despite criticism of price pres-sure from governments, the execu-tives also admitted there was roomfor improvement in pharma indus-try practices.

Chairing the conference,Richard Barker, head of the UKindustry body the ABPI, said theindustry had to improve its failingproductivity, the number of newdrugs having fallen in recent yearswhile R&D spending has soared.

He said: “We have the problemin research of starting out with onemillion molecules and then endingup with just one.

“We absolutely have to invest inbiomarkers and use technologysuch as stem cells for predictivetoxicology.”

Better R&D productivity wouldalso take the pressure of new drugprices, with companies under lesspressure to recoup their overallcosts from just a few products.

Barker concluded: “Unless wecan get this one million to oneproblem cracked, we will alwaysbe struggling.”

You are reading the first edition of PharmafocusEurope, a new publication set to become an indis-pensable business tool for all pharmaceutical indus-try executives with an interest in Europe.

Launched in March, the new quarterly publica-tion will be received by pharmaceutical and biotechexecutives in senior marketing, sales and R&Dpositions across Europe.

The new publication is a spin-off from themonthly UK publication Pharmafocus, which hasestablished itself as the most authoritative UK phar-ma industry monthly.

Pharmafocus Europe will provide readers withthe best analysis and news round-ups fromEuropean and global markets, including new prod-uct launches, developments in national healthcaremarkets and much more.

“Pharmafocus has established a very strong rep-utation in the UK for its unique editorial content,which provides readers with news and analysis thatwill help them in their working lives,” said AndrewMcConaghie, Executive Editor of Pharmafocus andPharmafocus Europe.

For executives who need to keep up-to-date withcustomers and competitors, but who don’t havetime to read long-winded articles, PharmafocusEurope provides well written and easy-to-read arti-cles in clearly defined sections.

“We feel that existing publications which caterfor the pan-European pharmaceutical industry don’treally provide an easy-to-read and informativedigest of this fast-moving industry,” said Andrew.

“There are some publications published frequent-ly which cover the week-by-week events in pharma,but don’t pick out the top stories and trends whichemerge over a year.

“Other pharma magazines cover Europe, butdon’t provide a news digest or much analysis, mak-ing it hard to see the bigger picture.

“So every quarter, Pharmafocus Europe will bethere to provide an informative and accessibleupdate on both recent events and major events onthe horizon.”

UK readers clearly agree that Pharmafocus isproviding an indispensable service. A recent inde-pendently conducted poll found Pharmafocus to bethe most thoroughly read of all UK monthly phar-ma publications, and the one that most wouldchoose to read above all others.

Pharmafocus Europe:Indispensable insight four times a year

Pfizer Strikes BackMove to block distribution of

EU’s first generic Lipitor (p5)

Into the FutureNovartis’ James Shannon on

drug development (p8)

Europe

Pharmafocus

Spring 2007

European biotech compa-nies ThromboGenics andBioInvent are to start a phaseI trial of a new drug whichcould prove to be a safer andmore convenient anti-clottingtreatment.

Patients taking anti-coagu-lants today have to bemonitored closely to ensurethe drugs do not cause bleed-ing, but early data suggest thenew TB-402 is free of thisconcern. The study willinvestigate the safety, tolera-bility and pharmacokineticproperties of the drug, withresults expected in late 2007.

The companies wereawarded a €2m grant by theEU in December to fund theprogramme. TB-402 repre-

sents the first drug in a wideralliance between Thrombo-Genics and BioInvent toreach the clinical phase.

TB-402 is a human anti-body binding to Factor VIII,which plays a crucial role inthe coagulation of the blood.Extensive testing in severalanimal models has shownthat TB-402 strongly reducesthe risk of thrombosis with-out increasing the risk ofbleeding.

The companies hope tocontinue development intophase IIa trials in patientsundergoing orthopaedicsurgery who are at risk forthrombosis. TB-402 is alsoexpected to be developed as atreatment to prevent blood

clots in patients with certaintypes of heart arrhythmia,such as atrial fibrillation.

Professor Désiré Collen,chief executive of Thrombo-Genics commented: “The

entry of TB-402 into formalclinical development is animportant milestone forThromboGenics and ourpartner BioInvent.

“We are both excited about

the potential of this novelanti-coagulant, which actsvia binding to Factor VIII, toprevent thrombosis in a num-ber of important diseasesettings.”

The development of TB-402 is part of an alliancebetween ThromboGenics andBioInvent, launched in Sep-tember 2004. The companiesare also working on thedevelopment of TB-403(anti-PlGF), a novel anti-angiogenesis therapy fortreatment of tumours, inflam-mation and eye disease.

ThromboGenics, based inLeuven in Belgium, has fiveproducts already in phase IIdevelopment, three of whichare in cardiovascular disease

and two in ophthalmology.The company’s lead prod-

uct is microplasmin, a stableproteolytic enzyme which isin phase II trials for eye dis-ease and thrombotic disease.

BioInvent is based in Lund,Sweden, and is collaboratingwith a number of other com-panies on developing newdrugs, including ALK-Abelló, Antisoma, Glaxo-SmithKline and Immuno-Gen.

In January, BioInventstruck another licensing dealwhich may prove to be one ofits most important. Genen-tech, the company behinddrugs such as Herceptin andAvastin, signed a deal withthe company to develop and

co-market a new cardiovas-cular drug.

BI-204 is in pre-clinicaldevelopment, but could bethe first drug to directlyblock the furring-up of arter-ies which can lead to heartattacks and strokes.

Genentech has made anupfront payment of $15m toBioInvent, with up to $175min milestone payments andfurther royalties on sales inNorth America also due ifand when the drug reachesthe market.

Genentech and BioInventco-develop the drug, withGenentech marketing thedrug in North America, andBioInvent holding marketingrights in the rest of the world.

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Industry Advisory Panel

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Forest Laboratories Europe

Gill Markham Corporate Affairs Director, Wyeth

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Novartis attacked for legal action over Glivec patent

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Hello and welcome to the very first issue of

Pharmafocus Europe.

Don’t worry – this isn’t one of those rambling editorial mono-logues you see at the front of some publications. I know you’rebusy, so I won’t keep you long.

Pharmafocus Europe is a brand new quarterly publication foranyone with an interest in keeping abreast of the pharmaceuticalindustry in Europe and around the world.

We won’t present you with acres of print to read just to get a feelfor the basic facts. If you want the very latest updates, you can use the internet (includingwww.pharmafocus.com) but if you are looking for a news review which puts events intosome context, then look no further.

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Novartis has come up againstfierce resistance in its attempt tosecure a patent for Glivec in Indiaand its challenge to the country’sambiguous patent laws.

The company wants an Indian-court to clarify what intellectualproperty protection exists in thecountry, but denies the case isabout restricting patient access tomedicines.

But the company’s critics see itsmove very differently. Non-govern-mental organisations Oxfam andMedicins Sans Frontieres havemounted a campaign against thecompany, and say the move is anattack on India’s generic drugindustry and the cheap medicines itproduces – particularly those forHIV/Aids.

Medical director of MSF’s Cam-paign for Access to EssentialMedicines Dr Unni Karunakarasaid: “Novartis is trying to shutdown the pharmacy of the develop-ing world. Indian drugs account forat least a quarter of all medicineswe buy and form the backbone ofour Aids programmes.

“Over 80% of the medicines weuse to treat Aids come from Indiaand we cannot stand by and letNovartis turn off the tap.”

Novartis says it is only trying tosafeguard incentives for researchinto new medicines and that grant-ing Glivec a patent won’t lead togeneric versions of the drug beingblocked in India or affect the avail-ability of HIV/Aids drugs in poorercountries.

Managing director of NovartisIndia Ranjit Shahani said: “Thiscase in India is not about patientaccess. Lost in this debate is thepoint that patents help patients bystimulating the long-term researchand development efforts needed todevelop breakthrough therapieslike Glivec.”

The company says there is no realmarket for Glivec in the country,where even generic versions of thedrug still cost more than four timesthe average annual income. Lessthan 7,500 patients are prescribedGlivec in India and of these, 99%

receive it free of charge fromNovartis through its patient assis-tance programme.

The nature of Novartis’ legalchallenge has led NGOs like MSFto accuse it of overstepping themark by challenging not just thesection of law that denied Glivec a

patent, but also the country’s intel-lectual property system.

Before 2005, India had no patentlaws, but in 2003, Novartis wasgranted exclusive marketing rightsby the Indian Patent Office – mak-ing it the first pharma company toreceive such a distinction.

But officials have ruled thatNovartis’ patent application in2005 was not more efficacious thanthe base compound Novartis firstinvented in 1993, before refining itinto the drug that became Glivec.Under Indian law, patent applica-tions can be refused for medicinesin the public domain prior to 1995.

The idea that Glivec is not anadvance in treatment seems absurdto most who are familiar with the

cutting-edge science behind it andits exceptional ability to extendlives of patients with Philadelphiachromosome-positive chronicmyeloid leukaemia.

The innovative science behind thebreakthrough cancer drug has beenwidely recognised across the scien-tific community. It has won manyawards, including the the presti-gious UK Prix Galien award in2002, when it was one of two‘smart’ cancer drugs to take jointtop honours.

Running parallel to the Glivecbattle is another patent controversyin Asia. Merck took the decision inFebruary to cut the price of its HIVtreatment Efavirenz by around 14%for the world’s poorest countriesand those hardest hit by the disease,in a bid to prevent the Thai govern-ment using an Indian-made genericversion of the drug.

While many have sympathy withThailand’s efforts to cut HIV drugprices, it has also overturnedpatents on Sanofi-Aventis’ clot-busting drug Plavix, which is notclassed as an essential medicine forpublic health.

Dr Margaret Chan, director-gen-eral of the World HealthOrganisation took the unusual stepof writing to the Thai health minis-ter recently, suggesting it hadoverstepped the mark on the Plavixpatent, but Thailand remains unde-terred and stands by its decision.

Pharmafocus Europe

Between a rock and a hard place

World News

In This Issue.....

2007 LaunchesPharma looks set to see a healthy year fornew product launches in 2007, but the paceof patent expiries is also picking up andprice pressures continue.

This year, some 25-35 new productlaunches are expected, a comparable levelto 2006’s 30 launches, but many of thesewill be speciality products serving nichemarkets. This means new products will con-tribute less to overall market expansion –and company profits – than in the past.

Moreover, market expansion from newproducts is not keeping pace with the lossof patent protection by older products. In2007, marketed products with a value over$16 billion are likely to lose patent protec-tion, coming on top of the $23 billion ofproducts that lost protection in 2006.

Potential new blockbuster productsinclude Janssen-Cilag’s Paliperidone ERfor schizophrenia, Wyeth’s desvenlafaxinefor depression and in diabetes Merck’sJanuvia and Novartis’Tekturna.

Pharma Re-OrganisesIn January, Pfizer announced plans to cut10,000 jobs worldwide, including theclosure of its R&D operations in Franceand manufacturing sites in Germany. Moreon page 9.

Meanwhile, rumours of a Sanofi-Aventisand Bristol-Myers Squibb merger began tocirculate. A union of the two Plavix co-marketers would create a company to rivalPfizer’s size – but Sanofi-Aventis appearsto have cooled on the idea, with agreementnot reached over the value of BMS. Page 6

AstraZeneca announced plans to cut3,000 jobs in its supply chain operations,while even the currently top-performingcompany Roche has decided the time isnow right to re-organise its R&Doperations.

German health reformsGermany looks set to finally bring in newlaws to reform its healthcare system, afterthe country’s lower house passed a bill inFebruary.

Most agree reform is needed – Germany’shealthcare is one of the world’s best andmost expensive – but there has been long-

standing disagreement about how changesshould be made.

Chancellor Angela Merkel has had tocompromise on plans she originally put for-ward in 2005. The reforms are meant tostreamline the parallel state and privatehealth insurance systems to cut costs andbureaucracy. Supporters say it will makethe €140 billion a year system more trans-parent and market-orientated. But criticssay the ruling coalition’s compromiseagreement will increase bureaucracy andraise costs for the public. Page 4

Anti-corruption drive in ChinaThe former head of China’s medicines reg-ulator was arrested in January on suspicionof corruption. Zheng Xiaoyu is under inves-tigation for alleged taking of bribes, withfive senior figures in the agency arrested onsimilar charges.

The government said some Chinese drugcompanies had given bribes to gainapproval for substandard or dangerousmedicines. One drug, Xinfu, an antibioticmade by a company in Anhui province ineastern China is said to have caused 10deaths in the last year before it was banned.

Paediatric legislationNew EU legislation on paediatric medicinewas introduced in January. The laws containboth obligations to test on children as wellas commercial incentives to carry outresearch, notably a six-month market exclu-sivity extension.

FDA post-marketing checksUS regulator the FDA is to monitor newdrugs more closely with the aim of avoidinganother Vioxx-style safety scare. Theagency is to pilot a programme to producereports on selected new drugs 12-18months after their approval, which wouldflag up any potential concerns.

Critics, nevertheless, see the FDA’s plansas insufficient, and want to see new lawspassed to strengthen the agency’s monitor-ing powers. The US pharma body PhRMAworked closely with the regulator on theplans and strongly supports them, fearfulthat new laws could create extra hurdles fornew drugs to clear.

Healthcare in Germany is changing

This is not about patient

access – lost in the debate

is that patents help

patients.

Novartis India’s Ranjit

Shahani

The Future of Medical Communications

Studying for an MBA in Europe

The Take Home MessageConcentrated Pharma News

p4

p10-15

p16

Spring 2007 Vol 1 Issue 1

4

The Office of Fair Trading wants toreform the way prescription medi-cines are priced to reflect thebenefits they bring to patients.

Its long-awaited report into UKdrug pricing recommends replacingthe current Pharmaceutical PriceRegulation Scheme (PPRS) after itfound the NHS was paying toomuch for some treatments.

OFT chief executive John Fingle-ton said: “Focusing prices on theneeds of patients rather than on thecosts of drug companies would begood not only for patients, but forbusiness, too.

“It would allow more patients bet-ter access to more effectivetreatments, and it would focus drugcompany innovation and investmenton the areas where patients need itthe most, creating more valuabledrugs in the future.”

The report identified a number oftreatments where prices were “sig-nificantly out of line with patientbenefits”, including cholesterol,blood pressure and stomach aciddrugs.

The NHS spends about £8 billiona year on branded prescription med-icines, but some drugs currentlyprescribed in large volumes are upto 10 times more expensive thansubstitute treatments that deliververy similar benefits to patients, thereport said.

The current PPRS allows compa-nies to set their own prices withinvery broad profit constraints. Thevoluntary scheme is negotiatedevery five years between theDepartment of Health and the Asso-ciation of the BritishPharmaceutical Industry, with the

current scheme running from 2005to 2010.

The OFT proposes replacing itwith a fully reformed PPRS from2010, with maximum prices forbranded drugs set on value-basedprinciples. Similar systems arealready used by a number of coun-tries, including Sweden, Australiaand Canada.

In the UK, cost-effectivenessanalysis would be undertaken byNICE, the Scottish Medicines Con-sortium and the All WalesMedicines Strategy Group withwork coordinated by agreementbetween the health departments inthe UK.

The OFT estimates its proposedscheme would save the NHS around£500 million, which could be usedto improve patient access to medi-cines and other treatments they arecurrently denied.

The OFT launched its unprece-dented investigation into the PPRSin September 2005.

In the course of its inquiry, itworked with the National AuditOffice to analyse the scheme’sworkings, surveyed 1,000 GPsabout their prescribing behaviourand consulted with key stakeholdersin government, industry and NHS.

The Department of Health andDepartment of Trade and Industrynow has 120 days to consider andrespond to the OFT’s findings andrecommendations.

Another report, from the NationalAudit Office looking at NHS pre-scribing, is expected shortly. Theindustry hopes it could provide analternative solution to increasingvalue-for-money in medicines.

European Review

universal healthcare coverage fordecades, but with their countrybeing faced with having to payfor medical advances for an age-ing population – a cost pressurecommon to other developednations – the government hasbeen striving to cut spending.

In addition to improving healthinsurance coverage, the reformsalso introduce changes to the waymedicines are reimbursed in Ger-many – an already fraught areafor pharmaceutical companies.

Since 1989, the German indus-try has been subject to referenceprices, which establish maximumlimits for which health insurancefunds pay for certain drugs.

This system was expanded in2004 through the SHI Modernisa-tion Act, which placed drugswithout a novel mode of action ortherapeutic improvement at riskof being subject to referenceprices.

The Act also brought back‘jumbo class’ reference pricing,whereby drugs are grouped intolarge classes, such as statins, sar-tans and triptans, and patentedand generic treatment reimbursedat the same rate.

Since the Act became law, everymanufacturer has had to cut theprice of their new drugs to matchthe reimbursement rate with onlyone exception – Pfizer and Sortis.

The drug company was told itsblockbuster Lipitor, which is soldin Germany as Sortis, was notinnovative enough to be excludedfrom the pricing system. Thecompany refused to reduce itsprice to the reference price for

statins for fear of affecting pricesin other European markets and sopatients had to pay the differencebetween the reference price andthe market price and sales conse-quently fell by some 60%.

More recently, insulin priceswere put under the microscope bythe health ministry, forcing manu-facturers to shave up to 30% offtheir prices.

Lilly, Novo Nordisk and Sanofi-Aventis all cut the price of theirfast-acting insulins after Ger-many’s health-cost panelconcluded benefits from thenewer products did not merit a

higher price than older ones. Sanofi has also come to blows

with the government over its deci-sion to count the obesitytreatment Acomplia as a‘lifestyle’ drug and therefore noteligible for reimbursement.

The French firm said it consid-ered the classification unjustifiedgiven its drug’s therapeutic pro-file and it will contest the rulingin court.

Acomplia was launched acrossEurope last summer and a num-ber of markets have decided toreimburse it, including France,Sweden and Ireland.

The issue of pricing and reim-bursement came up last year in ameeting between US deputy sec-retary of health Alex Azar and hisGerman counterparts.

He told them: “Governmentactions affect prices, prices affectinvestment, investment affectsinnovation, and innovation affectshealth.

“The more free competitionthere is in the pharmaceutical andmedical device market and themore barriers to innovation gov-ernments remove, the moreinnovation and health the worldwill enjoy.”

The German parliament hasfinally cleared Chancellor AngelaMerkel’s reforms to healthcarefunding, paving the way for theirintroduction on 1 April.

From April, all Germans willhave access to statutory health cov-erage for the first time, bringingparticular benefits to the 300,000mostly self-employed and freelanceworkers who currently lack regularhealth insurance.

Health Minister Ulla Schmidt toldparliament: “Everyone will infuture be insured and for those cur-rently without it, this meanswelcome to solidarity: you are nowinsured, too.”

Since its election in November2005, Merkel’s coalition govern-ment has made healthcare policy apriority for its four-year term, butpolitical wrangling has made theBill’s passage towards law difficultand has forced compromises.

Critics in government and opposi-tion have argued the reforms willnot lower employer and employeehealth insurance premiums, will sti-fle competition between insurersand increase red tape.

Supporters say it will providemore competition and flexibility tothe health insurance market and

guarantee high-quality medicaltreatment for all in future.

German citizens have had near-

Merkel breakthrough on German health reformsAfter months of wrangling, reforms have been agreed - but will they solve Germany’s problems?

Both houses of parliament have finally agreed the healthcare reforms

The UK industry associationthe ABPI has opposed theOFT plans, saying they couldintroduce a system similar toreference pricing seenelsewhere in Europe, which isuniversally seen as damagingfor competition in theindustry.

“The UK gets its life-improv-ing – and saving – medicinesat a fair and reasonable price,and the broad assertions thatthe OFT has made in launch-ing its study are wrong,” saidDr Richard Barker, DirectorGeneral of the ABPI.

“However, the pharmaceuticalindustry wholeheartedly sup-ports the desire of the NHS todeliver value for money, andwe are ready to sit down withthe government to discussways in which this might bebetter achieved.”

Having made healthcare a

priority, Chancellor Merkel’s

reforms offer universal

access to statutory health

coverage for the first time

Pharma & healthcare news from across the continent


Spring 2007Pharmafocus Europe

Industry opposes new ‘Value-Based’ pricing system proposed for UK market

Sebivo (telbivudine), fromNovartis, for treatment ofchronic hepatitis B in adultpatients with evidence of viralreplication and active liverinflammation.

Toviaz (fesoterodine), fromSchwarz Pharma for the symp-tomatic treatment of overactivebladder syndrome.

Astellas Pharma’s Advagraf(tacrolimus) is a more conve-nient, prolonged-release hardcapsule formulation of its drugtacrolimus for the preventionand treatment of transplantrejection.

The drug is already availableas Prograf administered viaintravenous infusion.

Licence extensions – two newcancer licences for Roche

Avastin is now licensed for usein combination with paclitaxelfor the first-line treatment ofpatients with metastatic breastcancer.

Avastin was first authorisedin Europe in January 2005 andis currently authorised for thetreatment of patients withmetastatic carcinoma of thecolon or rectum.

Xeloda has gained an addi-tional licence as a first-linetreatment of patients withadvanced gastric cancer incombination with a platinum-based regimen.

First authorised in the EU inOctober 2000, Xeloda is cur-rently licensed for thetreatment of patients with

colon cancer, metastatic col-orectal cancer and locallyadvanced or metastatic breastcancer.

Prevenar (pneumococcal con-jugate vaccine), from Wyeth toextend the indication fromactive immunisation againstbacteraemic pneumonia toactive immunisation againstpneumonia caused by strepto-coccus pneumoniae serotypes4, 6B, 9V, 14, 18C, 19F and 23.

Prevenar was first approvedin the EU in February 2001 andis currently approved for activeimmunisation of children fromtwo months to five years of ageagainst sepsis, meningitis, bac-teraemic pneumonia andbacteraemia caused by thesame serotypes.

Second mock-up pandemicinfluenza vaccine receives pos-itive opinion

The Committee for MedicinalProducts for Human Use(CHMP) has adopted a positiveopinion recommending forFocetria, Novartis Vaccines’mock-up pandemic influenzavaccine.

It is the second mock-up pan-demic influenza vaccine toreceive a positive opinion fromthe committee, followingGSK’s last year.

Mock-up pandemic influenzavaccines are approved only foruse in a declared pandemicinfluenza situation.

The aim is to have a market-ing authorisation in place for avaccine molecule that can beadapted quickly to include the

virus strain responsible, once ithas been identified.

Fosrenol launched in UKShire has launched Fosrenol(lanthanum carbonate) in theUK as a treatment to controlhigh levels of phosphates-hyperphosphataemia in chronicrenal failure patients onhaemodialysis or continuousambulatory peritoneal dialysis(CAPD).

If it is not managed success-fully, hyperphosphataemia cancause serious long-term healthrisks leading to renal osteodys-trophy (resulting in bone pain,brittle bones and skeletal defor-mities) and potentiallycontributing to cardiovasculardisease, which accounts foralmost half of all deaths amongdialysis patients.

Fosrenol is already availablein Austria, Belgium, the CzechRepublic, Denmark, Finland,France, Germany, Iceland, Ire-land, The Netherlands, Polandand Sweden.

Dr Alastair Hutchison fromthe Manchester Institute ofNephrology & Transplantationwelcomed the UK launch andsaid: “Control of hyperphos-phataemia remains an unmetclinical need in many patientswith chronic kidney disease,with many still having phos-phate levels well above therecommended limit.

“The introduction of Fosrenolto the UK provides patientswith a new, effective therapythat is easy and convenient totake, helping to simplify theircontrol of phosphate levels.”

Approvals & Launches

Ranbaxy has alreadylaunched its atorvastatinproduct in India and someother emerging markets, butthe company hopes Denmarkwill be the first of manymature markets to which itcan gain entry.

Analysts say the small sizeof the Danish market – whichspends an estimated $30 mil-lion on Lipitor a year –makes it a good test market,with fewer risks attached.

Ranbaxy is one of a hand-ful of major genericscompanies now challengingthe industry’s top sellers, butit has had limited success inchallenging Lipitor patentsso far. But favourable ver-

dicts in Norwegian, Aus-tralian and Canadian courtshave boosted Ranbaxy’sbelief that eventually it willbe able to market atorvastatinon a permanent basis.

Speaking on the day of itslaunch in Denmark in earlyFebruary, Malvinder MohanSingh, chief executive ofRanbaxy, said: “The intro-duction of atorvastatin inDenmark is a significantmilestone in Ranbaxy’s ator-vastatin strategy and heraldsthe beginning of the com-pany’s determined efforts tobring affordable atorvastatinto patients in Europe andother parts of the world.”

He continued: “Generic

atorvastatin will bring signif-icant and immediate costbenefits to the Danish health-care system.”

So far, Pfizer has been verysuccessful in defending itspatents on Lipitor in themajor markets around theworld, including the US andthe UK.

Pfizer has another fouryears before its basic Euro-pean patent on Lipitorexpires in 2011, and willfight to maintain its grip onthe drug, which is the main-stay of its sales.

Lipitor earned sales of $13billion worldwide in 2006,representing more than aquarter of Pfizer’s total sales.

Pfizer has gained a courtinjunction ordering thewithdrawal of a genericversion of its top-sellerLipitor (atorvastatin).

Indian generics companyRanbaxy launched its copyof the world’s biggest sell-ing drug in Denmark on 12February, but the courtorder blocked its sale just11 days later.

The Danish launch ofgeneric atorvastatin wasthe first in the westernworld, and Ranbaxylaunched the drug ‘at risk’knowing that the courtcould intervene shortlyafterwards.

Pfizer and Ranbaxy areawaiting a definitive courtruling on the drug’s patentin Denmark, but thegeneric company had

seized an opportunity tolaunch its product ahead ofthe verdict.

Ranbaxy had gambled onthe pre-emptive launchhelping it to seize marketshare, but it may ultimatelyhave to pay damages toPfizer if it loses the case.

“This ruling is anothersignificant milestone inour defence of Lipitorpatents around the world,”said Pfizer senior vicepresident and generalcounsel Allen Waxman.“And it’s an important out-come for Pfizer and othermedical innovators whoinvest in high-risk researchto develop life-savingmedicines for millions ofpatients,” added Karin Ver-land, country manager ofPfizer Denmark.

Court orders withdrawal of generic Lipitor in Denmark



A court injunction has forced Ranbaxy towithdrawl its competitor to Lipitor, above

Swiss specialist pharmacompany Actelion sawsales revenue rise 43% in2006 thanks to rapidgrowth in its two prod-ucts, Tracleer andZavesca.

Founded 10 years ago,Actelion specialises ininnovative science relatedto the endothelium – thesingle layer of cells sepa-rating every blood vesselfrom the blood stream.

Tracleer (bosentan) islicensed to treat pul-monary arterialhypertension, a rare butpotentially fatal heart con-dition which has few othertreatment options.

The company’s otherdrug, Zavesca, is anenzyme replacement ther-apy for another rarecondition, the inheritedGaucher’s disease causedby a genetic fault.

Chief Executive Jean-Paul Clozel commented:“In 2006, Actelion has yetagain improved its finan-cial performance, drivenby strong product salesand a careful upsizing ofour infrastructure. Impor-tantly, we are now moreand more benefiting fromour ongoing efforts inresearch, as our productpipeline rapidly expands.

“The S1P1-partnershipwe entered into withRoche in mid-2006clearly demonstrates theinnovation power of Acte-lion’s research as well asour determination to max-imise the medicalpotential and the relatedvalue creation from ourcompounds.”

The company says itspipeline is maturing well,with 10 different chemicalentities in clinical devel-opment, (five in phase III)by the end of 2007.

Jean-Paul Clozel says allthe molecules focus onareas of high unmet med-ical need, such as anorexin receptor antagonistfor sleeping disorders,where he says manypatients are goinguntreated because of thelimitations of currenttherapies available.

The company saysspending on its R&Dpipeline and companyacquisitions will continue.

It has just finalised thebuy-out of Californianbiotech CoTherix whichspecialises in treatmentsfor cardiovascular dis-ease. Ventavis (iloprost) isone of the CoTherix’s keydrugs, and like Tracleer, isalso for pulmonary arter-ial hypertension, but in acomplementary subset ofpatients.

Christian Chavy, presi-dent of businessoperations, said: “In 2006,we have been able to wit-ness a further expansionof the pulmonary arterialhypertension (PAH) mar-ket. As the market leader,we have been, and willcontinue to be, committedto increasing diseaseawareness through a widevariety of educationalefforts. Based on thestrong clinical data withTracleer in many differentforms of PAH, we havebeen and will be able toreach out to a growingnumber of different spe-cialists treating patientslikely to suffer from thisprogressive disorder.

“We expect diseaseawareness to increase fur-ther with the upcomingavailability of otherendothelin receptor antag-onists. Actelion is wellpositioned to benefit fromthe resulting marketexpansion, especially asthe recently concludedEARLY study againshowed that our dualendothelin receptor antag-onist is delaying time toclinical worsening, evenin the less advanced PAHpatients.”

A number of furtherindications for Tracleerare the cornerstone of thecompany’s pipeline, plusit has some 25 active drugdiscovery programmescurrently in progress.

The company says itsdiscovery efforts couldlead to as many as two ormore compounds enteringfull pre-clinical testingevery year.

Two products fuellingActelion’s growth spurt

DIA European Branch Office: Elisabethenanlage 11, Postfach, 4002 Basel, SwitzerlandTel. +41 61 225 51 51 Fax. +41 61 225 51 52 email: [email protected] www.diahome.org

DIA’S 19TH ANNUAL EUROMEETING –MARCH 26-28, 2007 IN VIENNA, AUSTRIA

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EUROMEETINGVIENNA 2007

19TH ANNUAL

6

Sanofi-Aventis cools on takeover bid for Bristol-Myers Squibb


Bulgaria and Romaniabecame the latest coun-tries to join the EuropeanUnion on 1 January thisyear, swelling the numberof member states to 27.

The neighbouring East-ern European countriesare among the poorest inEurope, but their pharma-ceutical markets aregrowing fast.

Foreign drugs make upless than a third of pre-scriptions in bothcountries, but in salesterms account for two-thirds of the region’sspending on medicines.

Many consumers favourforeign-made medicines,and will purchase these

products if and when theycan afford them.

Romania currently hasdifferent reimbursementrates for patent-protectedbranded medicines andgenerics – 50% and 65%,respectively, a highlyunpopular policy with thepharma industry.

Reference pricing wasalso recently introduced inthe country, seeminglyconfirming fears that thegovernment is targetingforeign-made medicines.

Bulgaria has also beenwarned by the EuropeanCommission over signsthat its patent laws may beweakened by a recentamendment to them.

Romania and Bulgaria join European Union

Merger talks betweenSanofi-Aventis and itsPlavix co-marketer Bris-tol-Myers Squibb havereportedly stalled.

Disagreement over justhow much Sanofi-Aven-tis should pay to buyBMS is understood to bethe main sticking point,and the situation is fur-ther complicated by theimpending legal battleover the marketing ofPlavix in the US.

The mishandling ofnegotiations with ageneric challenger toPlavix in the US hasbeen the undoing ofBMS, with chief execu-tive Peter Dolan forcedout in September lastyear.

Since then, BMS hasbeen open to takeoverbids, but Sanofi hasalways been the mostlikely buyer because ofthe Plavix partnership.

An article in TheTimes, published in theUK, claimed Sanofi wasnot happy to pay the $28per share valuation sug-gested by BMS, a reportthe French companiesdeclined to comment on.

BMS’ head of mergersand acquisitions TamarHowson left the com-pany in early Februaryjust as negotiations withSanofi were believed tobe getting underway,suggesting that the com-pany’s top managementis split over the beststrategy to follow.

Most analysts believethat a takeover isinevitable for BMS, andthat it could find a num-ber of other interestedmajor pharma compa-nies if Sanofi drops outof the running for good.

Sanofi’s figures dentedThe fall-out from theentry of a generic Plavixproduct in the US badlyeroded 2006 sales at bothcompanies.

Demand for the drug,in both its branded andgeneric form (clopido-grel, pictured) rosethroughout the year inthe US, but Plavix salesfell 61% in the finalquarter.

Overall, Sanofi’s salesrose by 2.5% to €25.8billion in 2006, Sales ofits top 15 products,which include Plavix,Lovenox, Stilnox andTaxotere accounted fortwo-thirds of annualsales (€17.3 billion).

Sanofi faces anothergeneric battle after a UScourt overturned thepatent on its blood thin-ner Lovenox. The drugremains the company’sbest-seller, with sales of€2.4 billion worldwide,up 12.9% on the previ-ous year.

Healthcare reformshave led to public spend-ing restrictions in Franceand Germany, whichSanofi says also under-mined its performanceduring 2006.

Europe in Pictures

Decision delayed? Sanofi-Aventis’ chief executive Gerard Le Fur (pictured, far right) and chairman Jean-Francois Dehecq may be waiting

until legal wrangles in the US over Plavix are resolved. A Sanofi-BMS merger would overtake Pfizer to become the sector’s biggest.

see what you’re looking for in an ad agency

www.langland.co.uk

7

Four new pan-European pharmaceutical companies have emergedafter a whirlwind period of mergers and acquisitions towards the end of2006. German companies were involved in each of the four mergers,but of these, only the tie-up between Bayer and Schering retained aheadquarters in that country.

Damstadt-based Merck bought Italian biotech Serono but movedacross the border into Switzerland, which Serono had chosen as the sitefor its HQ before the merger.

Bad Homburg’s Altana was acquired by Finland’s specialist pharmacompany Nycomed, and the combined group’s headquarters will oper-

ate from Zurich. Pictured (top right) is opening of the company’s UKheadquarters, with country manager Julian Trimming on the left andregional head Timo Tiiovla.

Finally, Belgian pharma company UCB (not pictured) acquiredSchwarz Pharma, and will retain its headquarters in Brussels.

European pharma’s newly-merged, mid-sized companies launched

Pictured: vets release a goose from a barn after itwas vaccinated in the village of Sharapovo outsideMoscow after a case of the H5N1 bird flu virus wasfound nearby.

GSK is one of a handful of companies attemptingto develop vaccine which could combat the con-stantly mutating virus should it cross from animalsinto humans.


Europe in Pictures

On 1 February, France became the latest Euro-pean nation to introduce a ban on smoking inmost public places,

Smoking in bars, restaurants, hotels and night-clubs will be banned from 1 January, 2008.

The European Commission is now urging a banacross all 27 members of the EU.

Russia on bird flu alert

France says ‘non’ tosmoking in public places

Pharmafocus Europe a Wiley publication8

Hello James, and thanks for taking time to tell usabout your work at Novartis. Getting straight to thepoint, what’s the Number One challenge in drugdevelopment today in your view?

Shannon: “Continuing to bring novel medicines tomarket which bring value to patients is, of course, thereally fundamental challenge.

“An illustration of how hard the industry as a wholehas found that recently is the figure for the number ofapprovals. Last year, the FDA approved just 17 or 18new molecules. That is the lowest for many years. At Novartis, we think we have a good chance ofchanging that situation. If you look at our pipeline,we have 138 projects and 50 NMEs in clinical devel-opment, and included in there are a lot of trulyinnovative medicines.

“We are bringing through medicines which aren’tall ‘me too’ molecules but ones which are a little bitcutting edge and have new mechanisms.“Among our newest products are the first renininhibitor for hypertension (Tekturna) and the first

monoclonal antibody for asthma ( Xolair).”

So, is Novartis’ R&D policy a little bit riskier thanthat of other companies, in terms of pursuinginnovation?

Shannon: “You see us being pretty much out there onthe edge in terms of innovation. And in terms of newmolecular entities, I think we are prepared to takemore innovative molecules forward, and we have avery clear push.

“But there is always a balance to be struck betweeninnovation and the more predictable projects. Theclassic ratio within the overall pipeline is about twothirds life cycle management or licence extensionprojects to one third innovative molecules.

“Even among the innovative medicines, we havesome, like the respiratory molecule QAB 149, whichis a long-acting beta agonist. So, it’s a new molecule,but from a well-known class.

“It’s innovative because it’s once daily and it’s moreeffective than others in its class, but it’s from a classof drugs we are familiar with and which we knowhow to develop and work on.

“It’s important to have that balance in your pipelinewhen you bring a totally new molecule to a regula-tory agency, because safety is inevitably a majorquestion in their minds when looking at first-in-classdrugs.”

Animal side-effects in Tekturna and GalvusA recent example of that contrast for Novartis hasbeen the progress of Exforge and Tekturna. Shannonsays Exforge, a combination of the tried and testedvalsartan and amlodipine “just sailed through theregulatory process” but that the FDA has taken a farmore cautious approach to Tekturna.

Shannon: “With a drug like Tekturna, you candemonstrate superior efficacy compared to existingtreatments, but the safety question dominates the dis-cussion.”

“Animal trials of Tekturna showed it had an irritanteffect on the gut in animals, and one tumour in ratswas recorded. A colonoscopy study looking at bowelirritation was conducted by Novartis and supplied tothe FDA, which showed absolutely no irritation of thehuman gut, which is consistent with all of our pre-clinical data from primate studies.

“They are now going to review the data and wedon’t have any more information, but there is nothingin that study that should cause them to be concerned.”

Galvus has experienced similar delays over safety,in this case because of skin lesions seen in trials onmonkeys. The FDA issued the drug with an ‘approv-able’ letter in late February, meaning further studiesneed to be carried out before it is authorised, includ-ing in this instance, studies of its safety and efficacyin specific patient groups with renal impairment.Despite the delay, Shannon is confident about thedrug’s safety profile.

Shannon: “There are more than 2,500 patient years[worth of clinical trial data] on Galvus, which makesit the best-examined diabetes drug ever. There isabsolutely nothing in that data which would cause usto believe the drug is not safe.”

Merck’s Januvia is in the same class as Galvus, ofcourse. What kind of claims can Novartis makeabout Galvus in comparison to its rival?

“It’s difficult to make that head-to-head statementuntil we see the FDA label. As we have studied it inphase III, I think the perception in the marketplace isthat Galvus has slightly better efficacy than Januvia.But we will look at how the FDA label looks to seehow we can profile and position the drug.”

Biomarkers: the future of drug developmentThese kinds of delays could be overcome with the useof so-called biomarkers – technology which essen-tially allows drug developers to predict how a drugwill work inside the human body. The promise of bio-markers is that they will allow researchers to skipanimal testing, which is time-consuming and fre-quently not an accurate indictor of how humans willrespond.

In the US, the FDA has launched the Critical PathInitiative to look at how biomarkers and otherapproaches can cut attrition in drug development,especially in the early stages. In Europe, the EMEAhas a similar programme called the European RoadMap.

Shannon: “These initiatives are all about changingthe way the regulatory authorities work with theindustry. There are lots of obstacles to getting newdrugs onto the market, which we can anticipate andtackle together.”

Does that mean new technology will have to bedeveloped?

“Yes, but there is also the sense that we haven’t reallyleveraged the technologies that are already availableto us today – including genomics and biomarkers.

“We have a big ongoing project within Novartis tolook at biomarkers, we have research agreementswith the FDA looking specifically at renal biomark-ers, while other companies are looking at hepaticbiomarkers and cardiac biomarkers.

“The intention is that through the Critical Path, wecome up with predictive biomarkers, so that when-ever we look at animal studies, we can predict betterwhat may or may not happen in humans.

“A lot of the discussions we have had with the FDAabout Tekturna and Galvus have linked clinical sys-tematology with genomic markers which we haveseen in animals.

“The aim is to be able to say ‘here is the mechanismof what you have seen in animals – but you don’t havethat mechanism in humans, therefore it is not likely tooccur in humans’.”

And the FDA really wants to see the same result asthe industry in this area?

“Absolutely. But this process is still in the early days.The FDA is trying to validate the biomarkers becauseat the moment it doesn’t know how truly predictivethese markers are.The FDA says that in order to con-solidate the data it has, it needs data standardisation,which is another really big challenge for the pharmaindustry and healthcare.

“We need to be able to standardise data from thepatient, through to the hospital or the doctor’s prac-tice, on to the company and finally arriving at theregulator.

“That way, we can do a lot more of these analysesand cross-comparisons – really trying to make thedata flow as seamlessly as possible and electronically.

You could envisage a situation where the data flowsfrom a sensor attached to the patient [in a clinicaltrial] right through to the agency without us having tofill out a case record form and all of the paperwork.”

The industry has been talking about that for sometime now, hasn’t it?

“Yes, but I think we are getting closer to it now.”

Just how long will that take, in your view? Will wesee something like that in, say, five years?

“Oh, maybe more! But Novartis is certainly makingprogress on this front. For example, we are doing aclinical study using only electronic data capture. Wewere the first to do that and we continue to be lead-ing in its use.

“So, where you will see many companies saying itwill take 3-4 months to close a database after the lastsubmission, we can have the initial results after just

four or five days from the last patient. That’s atremendous improvement in productivity. Until then,we have to continue looking at each trial in isolation.Each trial has to be approved individually, which islike re-inventing the wheel every time.

“If you look at other industries, like aerospace, theywould never dream of doing what we do. They havea data model, have a hypothesis and then go on toprove that the data model is correct.

“So, whenever they build a plane, they have thedesign on a computer and all the risk factors are builtinto that computer model because they ask someoneto fly it. Whereas, we have to ask researchers to ‘flyblind’ and test a drug without any of that sort of com-puter modelling.”

Entelos and the promise of in-silico modellingEntelos is a US-based company specialising in com-puter ‘in silico’models which simulate how drugs willwork in humans. Analysts say the technology has thepotential to dramatically reduce costs of drug devel-opment and increase the chance of finding a safe andeffective molecule.

Shannon: “Novartis is working with Entelos to try tobuild models around diabetes, for example, so we canhave an in silico model of how a body reacts to drugs,and its interactions with other biological processes,and how it interacts with food..

“This modelling allows you to run thousands ofsimulations that can tell you what the range of doseswill be, what may or may not have an effect, and whatthe right patient population is.

“Diabetes is probably the most advanced in thisrespect, but we also have produced these models forGI and respiratory.

“As we turn biology more into a physical science, aswe understand pathways and what follows what, thenyou can start to get more reliable and more pre-dictable data every time.”

Finally, turning to the people who make thosesorts of breakthroughs you’ve been talking about– what motivates you and your staff?

Shannon: “As our portfolio has grown from 20-30projects 10 years ago to 138 now, our people are con-sistently looking for easier, better and more efficientways to do their work. They love the challenge ofconstantly raising the bar. But I think they get mostexcited by results from the molecules.

“Developing really innovative products is a verymeaningful way to spend your time, and it creates anexciting and challenging workplace. People naturallywant to be part of that.

“We are made up of scientists who are fascinatedand who love to do novel and innovative studies withbiomarkers, and we have also brought people fromthe outside to do model simulation – really skilledpeople. So, it’s a mixture of different things.”

Spring 2007Pharmafocus Europe

Novartis’ James Shannon talks to Pharmafocus Europe about how the company

is pioneering new technology to transform the science of drug development

“At the moment every trial has to be

approved individually, which is like re-

inventing the wheel every time.

If you look at other industries, like

aerospace, they would never dream

of doing what we do.”

Let’s stop flying blind R&D Focus

James Shannon, Head of DrugDevelopment,Novartis

Novartis’ pipeline therapy areas

Roche is restructuring itsglobal research and devel-opment operations in abid to make the companyfaster on its feet.

The company’s scien-tists will now be organisedaround disease biologyareas (DBAs), with newleadership teams in theUS and Switzerland. Eachteam is expected to man-age a drug’s journey tomarket through discovery,clinical research,exploratory development,clinical development andstrategic marketing.

Reporting to a newly-created committee madeup of senior pharma man-agers, they will decidewhich medicines to pur-sue in their area.Previously, the peopleresponsible for specificareas were often in differ-ent geographicallocations, so the newmodel is a bid to simplifyand accelerate decision-making.

Roche believes the newapproach will be moreefficient and effective intranslating research activ-ity into clinicallydifferentiated medicines.

“We’re taking the oppor-tunity to refocus at a timeof economic strength onthe challenges that lieahead,” said William

Burns, head of the com-pany’s pharmaceuticalsdivision.

Roche is indeed in themidst of a golden period,with oncology productssuch as MabThera/Rit-uxan, Herceptin andAvastin in particular,fuelling sector-leadinggrowth.

Significantly, almost allits new blockbusters weredeveloped by its sub-sidiary Genentech basedin the US, which has beenallowed to retain its small-scale biotech status.Roche, like many of itscompetitors is now look-ing to mimic many of thebenefits of this smaller,less bureaucractic busi-ness model.

Burns added: “Newstructures and flatter hier-archies will enable us tobe more aligned andfocused, take decisionsfaster, implement ideasmore rapidly, and bringmore new productsthrough the pipeline.”

The company says itcurrently has 32 projectsin research and 41 indevelopment in oncology,while in metabolism thereare 29 in research and 11in development.

Katja Prowald, head ofR&D communications forRoche Group, confirmed

there will be an increasethis year in both R&Dheadcount (currently7,000 worldwide) andbudget, which is CHF6.5

billion (£2.7 billion) atpresent.

Roche’s move is part ofa trend that has seenPfizer and GlaxoSmithK-

line tinker with their R&Dstructures in recent times,and there are several man-agement changes.

Co-ordinating researchacross Roche Pharmaceu-ticals, Roche Diagnostics,Chugai, Genentech andother partners will beJonathan Knowles, headof group research.

Lee Babiss, research sitehead in Nutley, New Jer-sey, will become head ofRoche Pharma research,reporting to Burns. Hisremit in the newly-createdrole will include oversee-ing research sites in Baselin Switzerland, Nutleyand Palo Alto both in theUS, and Penzberg, Ger-many – where therapeuticprotein research isexpected to be stepped up– and Shanghai, whereR&D activities will beexpanded to supportDBAs worldwide.

Meanwhile, chief med-ical officer EduardHoldener will continue tooversee drug safety andquality audit and beresponsible for setting upRoche’s development cen-tre in Shanghai until hisretirement at the end ofthis year. Jean-JacquesGaraud, his successor ashead of global pharma-ceutical development,took over last month.


“New structures and flatter hierarchies

will enable us to be more aligned and

focused, take decisions faster, implement

ideas more rapidly, and bring more new

products through the pipeline,”

William Burns, head of Roche Pharma

Roche’s R&D operations will now be organisedaround disease biology areas (DBAs) with newleadership teams in the US and Switzerland.

These five new therapeutic areas are: • oncology (based in Nutley, New Jersey)• virology• inflammation (both in Palo Alto, California)• metabolism • central nervous system (both Basel)

Pfizer is to close no fewerthan five research sitesaround the world, as partof radical top-to-bottomrestructuring of the com-pany’s processes.

Jeffrey Kindler wasappointed the company’snew chief executive inAugust last year, and hasannounced a series ofmajor changes, withR&D productivity takingcentre stage.

Pfizer plans to simplifyits R&D organisation andimprove productivity byconsolidating each of theresearch teams focusedon any given therapeuticarea (TA) which are cur-rently distributed inmultiple locations aroundthe globe, in many cases.

The teams will bebrought together at one offour major sites. Thecompany says each TAwill be run by a singleleader with “more respon-sibility, authority andaccountability” as well asmore control overresource decisions.

As part of the plans,Pfizer will close three USresearch sites, all inMichigan – its site in AnnArbour (pictured), a facil-ity belonging to acquiredbiotech Esperion also inAnn Arbor, and a third

site in nearby Kalamazoo.Its R&D operations in

Nagoya, Japan will alsoclose, as will those atAmboise in France,where just over 500 jobswill be lost.

Pfizer has decided toexit discovery research ingastroenterology and der-matology, but willcontinue to develop com-pounds already in thepipeline and seek externallicensing opportunities inthese areas.

“Our simplified struc-ture will help drive thegrowth of our expandingpipeline – including ourgoal to deliver four newinternally generated prod-ucts per year by 2011 –while maintaining currentR&D investment levels,”said Pfizer’s head ofR&D John LaMattina.

He continued: “Thiswill give us the ‘best ofboth worlds’ – the entre-preneurial spirit of asmall company, alignedwith the world-class tech-nologies, platforms andcapabilities that only acompany of Pfizer’s sizecan provide.”

The company says itsdrive to cut down onbureaucracy and reducethe number of manage-ment layers will include

the elimination of “manyunnecessary committeesand cross-functionalteams” and at present, it isin the process of cutting

at least three to four layersof management in itspharmaceutical, R&Dand manufacturing divi-sions, as well as in its

support functions com-pany-wide.

Kindler said: “Byreducing middle manage-ment and increasing

spans of control, we’regetting leaders closer tocolleagues and customersand giving colleagues aclearer line of sight to

those aspects of the busi-ness for which they areaccountable. As a result,our managers will dele-gate, empower and focuson developing colleaguesmore than ever, and ourcolleagues will grow andtake on more responsibil-ity than ever.”

Kindler concluded: “Iam convinced that prod-ucts and services thatcontribute meaningfullyto the public’s health –and that address areas ofmajor unmet medicalneed – will always behighly valued.

“But I believe Pfizermust transform the waywe’ve done business inthe past in order to be suc-cessful in the future.”

Less Bureaucracy, More R&D

“This will give us the

'best of both worlds' –

the entrepreneurial

spirit of a small

company, aligned with

the world-class

capabilities that only a

company of Pfizer’s

size can provide.”

John LaMattina.

Pfizer’s head of R&D

Roche: “Flatter hierarchies” and faster decisions

Pfizer: French R&D centre to close in shake-up

Roche, currently Big Pharma’s fastest growing company, and Pfizer, the sector’sbiggest, have both announced major re-organisations of their global R&D operations.

M ax Jackson was recently appointedPresident of Emerging Markets andBusinesses at Publicis Healthcare

Communications Group.This means Max now manages the group’s

presence in the pharma industry’s fast-growingand most exciting markets – namely, AsiaPacific, South America and Central Europe.

Not only that, Max is also the group’s leadthinker on the use of new technologies andcapabilities in the digitial, e-business andinteractive areas.

We asked him where medicalcommunications and medical education fittedinto the overall picture in this fast-changingworld of pharmaceutical marketing.

What’s your view on the current state of meded in Europe?

A few years ago, we were all very excited aboutmedical education – it was very high growthand it has now established itself firmly inEurope. But to be honest, my feeling is that thegrowth in medical education has slowed down.

That’s probably because it built from a smallbase, but also because we are running into somesignificant governmental legislation pressures,as well as time pressures on the doctors.

Another factor is that Europe still doesn’thave a unifying continuing medical educationapproach. There is no unifying certifying bodyand each country does it very differently, soCME certainly hasn’t grown here to the extentseen in the US.

Just how disparate are European countries intheir approach to CME?

At one extreme, in Italy there are more than5,000 CME accrediting bodies – any hospital orinstitution or persons attached to those canbecome an accrediting body – so it is absolutechaos in terms of predicting the quality of theprogrammes.

In the UK, the funding for CME is in flux. Sowhat was a solid and simple thing, is beginningto get complicated.

The UK government has been content to letthe pharmaceutical industry run CME for them– because it was cheap – but I think thegovernment will now want to control whatinformation is provided to its doctors. I sensethat change is going to happen.

The other two big markets are Germany andFrance. I think the governments there take CMEvery seriously. We are seeing those two marketsstarting to make the most sense in Europe.

In the US, the trend towards separatingpromotional medical education and non-promotional medical education is wellestablished, with CME definitely in the latter.

We are starting to see that trend now inEurope, and a number of pharmaceuticalcompanies are starting to get very nervous abouthaving the same agency working on theirpromotional and non-promotional work.

Isn’t it difficult to see where the non-promotional crosses the line into thepromotional?

Yes, it can be. I think the promotional element ofmedical education will actually decline. We willsee a very different type of medical education,where we are giving the best possible educationfor the physician and the consumer, so they canmake the informed choice.

Patients are increasingly more informed, butcommunicating with patients hasn’t beenviewed as medical education, it has beenthought of as direct-to-consumer or PR.

But in many senses, med ed is now servingthat purpose, because it needs to talk to theconsumer. That’s a big trend.

The European Commission has said it doesn’twant to follow the US model, and there are

grounds to oppose that, I think.A well-known study from New Zealand

suggested that the US direct-to-consumertelevision advertising was not informing, butinstead, confusing the consumer.

However, I think governments across Europehave stated that they want patients to take moreresponsibility for their own healthcare, and thatthey should work with doctors to decide on thebest healthcare for them. In that context, they dohave to be provided with educationalinformation.

Governments want to provide education toconsumers which is balanced and isn’tconfusing, but governments haven’t gotsufficient resources to do that, so I think theywill increasingly work in partnership withpharma companies in that endeavour.

It’s going to be a question of how we get thebalance right between the commercial need ofthe pharmaceutical company versus ensuringthe consumer is properly informed.

I think a better informed consumer will helpthe physician make the right choice – andnaturally that could be one of the drugs thecompany is producing.

What do you make of the Herceptin case inthe UK?

10



The Future of Pharma’s Relationships with Key Opinion Leaders

Key opinion leaders (KOLs) have becomevery important in helping the industrypromote new medicines to doctors, butthere has been a tightening of rules aboutthis across Europe. Where does that leavethe industry/KOL relationship today?

I think key opinion leaders are now verymuch more aware and savvy. They knowwhat pharmaceutical companies are tryingto do, and are very aware of marketing. Iwould say they are more cautious than theyused to be.

They are less inclined to totally commit toa company; there is a general feeling that it’snot a good thing to be too much of anadvocate for any single company.

Relationships are still good, and it’s a veryimportant relationship – most of theresearch done is being funded by theindustry in one way or another.

There is a great deal of wariness, and a lotof government scrutiny on KOLs. In Italy,the government now prohibits doctors beingpaid to go to conferences. So, the classicrelationship of a pharma company hosting anumber of key opinion leaders at highprofile events – that is changing very, veryrapidly. In fact, I think it will probablydisappear altogether.

What elements will disappear?

The practice of hosting, of taking people tosymposia and sponsoring them at differentevents is going to be increasingly underpressure from regulatory bodies. That willchange relationships, and it is probablygoing to become much more of a workingrelationship, be it a clinical study or anadvisory board. I think all those activitiesare going to be under quite strong scrutiny.

In Italy, the government now prohibits

doctors being paid to go to conferences.

So the classic relationship of a pharma

company hosting a number of key

opinion leaders at high profile events –

that is changing very, very rapidly.

In fact, I think it will probably disappear

altogether.

The changing face ofmedical communicationsFour senior figures from European medical communications and PR share their

views on where the future of pharmaceutical marketing lies.

Max Jackson

“I don’t think we’ll look back and say‘that was the ‘End of Marketing’. We’rejust moving into a different phase.”

That is a bad example of patient power, because Ithink people were getting some degree of education,but it was probably getting a bit whipped up by themedia.

But you can envisage a healthy situation wherepeople can learn about their condition, andunderstand where a particular therapy fits into theirtreatment, and can then help their doctor make thatchoice.

So how can we take this forward in Europe?

There probably needs to be some kind of body toendorse or certify information. But we really aretalking only about disease states and awareness.Things will move much more slowly when it comesto communicating about the therapeutic optionsavailable.

And how do the EUmember states differ on thissubject currently?

Everyone is a little paralysed in this area, I have tosay. Because there was a European Directive saying‘No DTC’, everyone assumes you can’t do anything.

Germany was very much at the forefront, but therehas been a government clampdown on this recently.Before that, there were some public relations-ledarticles published for the general population whichactually named brands. That’s been stopped now,because it was going too far.

Few countries stand out, really, but in my opinion,Spain is probably the most forward-thinking at thisstage. In that country, there tends to be much morethinking about public health and talking to consumersin an informed way more than anywhere else inEurope.

You say that the practice of pharma sponsoringdoctors to attend symposia will probably die out(see box below) That will be a major won’t it?

Yes, a huge change. I look at these market places, andthe traditional channels for getting messages todoctors are all being closed down, to be honest. Idon’t think we are going to look on these things in afew years time and say that was the ‘End ofMarketing’ – it is just a phase and we will have tolearn to adapt and work within it.

Honestly, the standard of information andpromotion is going to have to get better, and focus ongetting the right information to the right peoplewithout being biased.

There are a million restrictions on actuallycommunicating to people without their consent, suchas the Data Protection Act, and in most Europeancountries these have made operating quite difficult,so the industry has to find new ways to get theirmessage across.

So, amidst all this change, is there one mediumemerging as the pre-eminent channel?As with the consumer world, we are seeing a hugefragmentation of our channels. Once, you would saythere were three channels – advertising, med ed andPR. There are now at least another 10 or 15 channelscoming in – from the internet, to call centres, socialmarketing and viral marketing and so on.

The dominant channels have been chipped into bythese fragmented channels. So, where agencies wereonce experts in one discipline, clients are going toneed expert planning in healthcare across thechannels – people who know what the appropriatevehicle is going to be for them at any given time,rather than just being experts in their one particularchannel.

But the old way is a lot simpler.

The pharmaceutical company that lets go andembraces a new approach – and there are one or twoI know that are starting to do this – they may just bethe ultimate winners. They have anticipated thefuture, and therefore, will be much better prepared forthis when it happens.

In my experience, the pace of change hasaccelerated very quickly.

It is going to be a mix of caution and risk-taking.You can’t abandon the tried and tested, because theywork and they are still there. But I think you are goingto have to start investing in some of the newtechnologies and approaches.

I recently saw some promotional spending figuresfor Germany. The overall advertising promotional

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spend, including medical education, has beendeclining year on year. But at the same time,what they classify as ‘dialogue marketing’ –communicating in a whole range of non-traditional ways – is increasing at about thesame rate. So, the market overall is decreasing

but the opportunity is significant.Advertising has been ‘globalised’ – is meded next?

There hasn’t been a lot of standardisation inmed ed. Med ed has generally been done on a

localised basis. There will be a global messageplan and a global publications plan, butgenerally most of the med ed will be left to thelocal countries.

But yes, pharma companies are nowlooking to standardise med ed and PR acrossthe regions, mainly from a financial basis.How successful that will be, I don’t know –because there is such a big variation acrossmarket places in terms of what you can andcan’t do.

From my experience with clients, when youstart trying to standardise it, you can end upwith a lowest common denominator that is notvery efficient in those market places whereyou can be a little bit more aggressive. So, Ithink you have to be a little careful withstandardisation in this arena.

People are now talking about a situationwhere globalisation is coming full circlewith a return to a more local approach.Do you think that will happen? continued over the page:

“If you look at Coca-Cola, McDonald’s

and some of the other big companies,

they went through globalisation in the

1990s, and now in the 2000s, they are

much more about localisation”

continued from previous pageYou can almost guarantee it. There aremany arguments for globalisation, orat least there are many arguments fornot duplicating. I think peopleconfuse those.

If you look at Coca-Cola,McDonald’s and some of the otherbig companies, they went throughglobalisation in the 1990s, and now inthe 2000s, they are much more aboutlocalisation. They are saying ‘OK, thebrand has an equity, but you need todo whatever you need to do in yourlocal market in order to capture theimagination. That’s why you will get acounter-reaction to globalisation,because you get these bland advertswhich don’t mean anything to anyone.

You are also in a market placewhere you are competing againstlocal companies which have justlocalised their campaign and this isresonating with the target audience.

But I don’t think we will get areversal of globalisation in terms oflarge contracts, bulk buying andduplication of effort. I think peoplewill say ‘we don’t have to have thesame words and the same picture inevery market place’. The way to go isto say that we want to communicatethe same emotion wherever we are inthe world.

We do have to adapt and we do

have to be creative in how we use ourchannels locally. So, I suppose that isthe wheel turning halfway. Buteveryone is under so much financialpressure, I don’t think the old dayswill come back.

How does that change come about?

Well, how does change happengenerally? You need somebody with avision who has enough power to forma ‘powerful coalition’, as they say. It isusually someone who decides thatthings have got to be done differently.

At the moment, we have got a lot ofvery big companies who are in thatstate. They are going to be the oneswho realise that the old models aren’tgoing to work for them anymore.

There are a couple of companiesthat everyone looks at, and when oneof those companies suddenly says ‘weare going to do X’, the door will beopened for everyone else.

Turning to your new remit in theemerging markets; are they alreadyinfluencing the way the industryworks in the mature markets?

The big emerging markets are China,India, maybe Russia and Brazil, withthe central European marketsfollowing behind.

Nothing that is happening in thosemarkets is currently having an impacton what we do, but when you look atthe long-term impact of India andChina – with very large populationswhich are very geographicallydiffused, speaking many differentlanguages, and all needing some kindof adaptation – I can see that being acatalyst to the regionalisation,localisation and personalisation ofour communications.

Maybe one area that may influencethe communications globally is thesheer scale of the Chinese market. InChina, you can’t physically printenough paper in patient leaflets tosatisfy those markets.

I know of clients there who willprint out 200,000 patient leaflets andput them in a hospital, and they willbe gone the next day, because there issuch a thirst.

You have to say this is not the wayto communicate to people – maybethey have read the leaflet, or maybenot. So, you look at other ways ofcommunicating. Around 10% ofChina has internet access – that issmall in percentage terms, butrepresents more people online than inthe US. But they are not accessing itfrom computers necessarily; they arelooking at it on their phones. Thatknowledge is going to be transferableto other marketplaces.

Aren’t marketers in the developedmarkets already having to fight toprevent their budgets from beingreallocated to those markets whichare growing more rapidly?

This is where you have to be carefulabout the emerging markets. China isa very exciting market, but when youexamine the numbers of those whocan afford to pay for healthcare, it isequivalent to a market like Spain’s.

In today’s terms, the market isn’tmassive, but the potential growth ishuge. Without doubt, people will bechallenging – should I invest dollarsin this country for zero growth or afew dollars in this country for a 10%growth and a huge potential? That isgoing to be a real challenge for someof these marketplaces.

Realistically however, most of thesecompanies that are in emergingmarkets are struggling to make goodmargins for the moment, because theyare not easy to get into.

Certainly in China, India andRussia, you are competing withstrong local industries with stronglocal influence. So it would be amistake to lose sight of the fact thatmost main revenue streams are stillgoing to come from the US, Europeand Japan.

12



Used as part of a combinationof initiatives to support thedevelopment of new treatments,pharmaceutical company-sup-ported medical education is adefined series of programmes.

These programmes are devel-oped with the broad aim ofsupporting and educating opin-ion leaders and physicians inrelation to new treatments.

However, the pharmaceuticalindustry has other communica-tion programmes that go beyondpure education; the term ‘meded’ in this arena is probably amisnomer.

Medical education is carefullyregulated and enables physi-cians and other healthcareprofessionals to benefit fromeducation advances throughunrestricted grants – these areregulated differently in differentcountries.

But these days, customer focusis more critical than ever, and itsimportance will only increase.Effective communication pro-grammes are therefore essential

for market development toensure the success of brands inan increasingly competitive

market. With true med-edbecoming subject to increasingregulation, it is important toclearly define broader pro-grammes – possibly mistakenlycalled ‘med ed’ at present – asmarketing communications.These may embrace elements ofmedical education, but they willhave marketing objectives attheir core.

Outside of the pharmaceuticalindustry, ‘marketing communi-cations’ is a frequently used

term. In pharma, it is importantthat we define what the term‘med ed’ stands for, in order that‘marketing communications’can be embraced as a legitimateway to maximise the potentialof brands.

William Hind is managingdirector at AlphaRmaximHealthcare Communication

A Sector Striving to be Creative

Europe med ed remains highlyvariable across markets and ther-apy areas but is in a healthy stateof change. The sector is strug-gling to become more creative ina bid to respond to regulatoryscrutiny within individual mar-kets and the need to providelearning that is measurably effec-tive. In our recent experience,implementing novel approachesis challenging as European mar-kets are much more conservativethan the US.

The sector is also becomingincreasingly competitive with alot of national boutique agencieshaving set up over the last fiveyears. The global med ed agen-cies are being reserved moreoften for the strategic elementsof medical education.

For our clients, med ed is anincreasingly important compo-nent of pharma marketing withpublic relations and public affairsalso featuring more prominentlyin primary care. Many new inter-ventions require a fundamentalchange in practice if outcomes

for patients are to be improved.Effective education with measur-able impact is increasingly seen

as the most direct way of achiev-ing beneficial change.

The impact of cultural under-currents and regional variationsdepends on the global nature of

the therapy area. Greater varia-tion and more adaptableprogrammes are required in ther-apy areas such as stroke, wherelocal practice and resources arehighly variable. Where morecommon objectives are shared,such as in infection, we havefound more universal delivery ofeducation to be successful.Increasing travel restrictions insome markets, such as Italy andGermany, also affect the way inwhich education campaigns aredesigned.

Formal continuing medicaleducation remains highly vari-able across markets and whileEuropean mechanisms exist,they may not always be as rele-vant to physicians when there isrecognised professional infra-structure locally. Delivery ofEuropean CME accredited pro-grammes will therefore remainvery different to implementationin the USA.

Chris Gray is managingdirector at Adelphi Group

From ‘Med Ed’ to Marketing Communications

There has been a gradual blurring ofthe lines between med ed and PR overthe last 10 years, making this anappropriate time to examine thepatient education challenges faced bycolleagues in PR.

The most high-profile of these wasthe introduction in 2006 of a newcode of practice in the UK from thatcountry’s industry association, theABPI.

Key revisions for med ed coveredthe presentation of data, standards ofhospitality and communication withthe public and healthcareprofessionals via the internet.

On the other side of the fence, thecode heightened the challenge

presented to those in public relationsfrom issue-driven PR, which ispoised to dominate the healthcarenews agenda as BMS’ CarolineAlmeida explains below.

Public relations practitioners morethan ever have to pay attention to theABPI Code of Practice in their day-to-day work. The code itself has beentightened and the industry is in themedia’s spotlight.

Examples of this can be seen in therecent headlines in the UK on thelevel of industry involvement andinfluence in certain NICE appraisals,and a reported error of judgementmade by a PR agency in offering

journalists financial incentives toattend a NICE hearing. The launch ofthe new code last year has provided aplatform for industry and agencies toreview the applicability of the code tothe PR sector.

The code allows for the exchangeof factual information aboutmedicines to be made available to thepublic either directly or indirectly.The guiding principles are that theinformation is presented in a factualand balanced way. Industry representsa source of news on a product, diseasearea, or access to medicines. We arelikely to be better informed about ourown products than other sources (forobvious reasons), but carry specific

responsibility to be balanced andtruthful. A media environmentreluctant to write about the merits ofthe latest product launch has meantthat PR practitioners have had to findnew ways to get the press to payattention to our news.

Those in the PR sector are familiarwith placing patient case studies inthe national press. We are seeingfewer product-driven patient casestudies in the media. Instead, there isa greater tendency towards issues-based healthcare reporting.

Working with the consumer pressto profile a disease or an issue facinga particular group of patients is adifferent way to operate and brings

fresh interest and challenges.Topics such as access to new

medicines, the inequality in access totreatment experienced by certainpatient populations – mental healthand learning disabilities were profiledin a recent Disability RightsCommission report – and adherenceissues seen in disease areas such ashypertension and HIV are all topicsthat resonate with the media andultimately the general public. Theseencompass a broader issue than justthe product itself.

Caroline Almeida is corporate &business communications manager,Bristol-Myers Squibb UK

Patient Education, PR & Codes of Conduct

It is important to define

what ‘med ed’ stands for,

so that ‘marketing

communications’ can be

embraced as a legitimate

way to maximise the

potential of brands.

- William HindRecent experience

shows that

implementing novel

approaches is more

challenging in Europe

than in the US - Chris

Gray

The sheer scale of the Chinese market will affect communications globally

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perfectly positioned to help educate and inform your key customers by interfacing with our

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The force behind your brand



A new treatment for HIVis to be fast-tracked inEurope and the US.

Pfizer’s new compoundmaraviroc is to receivean accelerated review – aprocess only granted tomedicines that candemonstrate potentialimprovements over cur-rent therapies.

The FDA will reviewthe drug in late April andif eventually approved, itwill be the first in a newclass of HIV/Aids treat-ments, known as CCR5antagonists. A Europeanreview is expectedaround the same time.

Rather than fightingHIV inside white bloodcells, CCR5 antagonistsprevent the virus pro-duced by infected cellsfrom entering uninfectedcells by blocking its pre-dominant entry route, theCCR5 co-receptor.

The discovery of mar-aviroc goes back 10years, when Pfizer’sresearch scientists at thecompany’s R&D head-quarters in Sandwich,Kent, first designed themolecule.

They found that around1% of Europeans wholacked the genes forCCR5 receptors were thevery ones resistant toacquiring HIV infection.

John LaMattina, presi-dent of Pfizer’s globalR&D department, said:“There is a profoundglobal need for newmedicines to helpHIV/Aids patients.

“We expect that CCR5antagonists, such as mar-aviroc, will becomecritically important, newtreatment options for

patients who are eitherresistant to or intolerantto current HIV/Aidstherapies.”

Dr Ethan Weiner,Pfizer’s global R&D vicepresident, commented:“Maraviroc is an out-standing example of therapid development andcontinuous innovationthrough whichresearchers quicklytranslated a scientifichypothesis into a promis-ing compound in thisarea of great medicalneed.”

If the drug is recom-mended, patients who aredeemed suitable to takemaraviroc will be able tocombine it with anothernew class drug, Merck’sintegrase inhibitor MK-0518, which has shownimpressive results inpatients who have notresponded well to cur-rent treatments. Theproduct is currently inphase III trials.

In September 2006,Beatriz Grinztejn, headof the infectious diseaseservice at the HIV/Aidsunit at the Oswaldo CruzFoundation, Rio deJaneiro, told the Ameri-can Society ofMicrobiology that MK-0518, when combinedwith other therapies, waswell-tolerated in patientswho failed to respond toor were resistant to theexisting antiretroviraltherapies.

Around 40 million peo-ple are currently infectedwith HIV/Aids world-wide, and it is estimatedthat four million newinfections occur globallyevery year.

New HIV therapy to be fast-tracked

Sebivo, a new hepatitis Btreatment from Novartisand Idenix, is set forapproval after gaining apositive opinion fromEurope’s regulator.

The EMEA’s Committeefor Medicinal Products forHuman Use (CHMP) rec-ommended approval ofSebivo (telbivudine), aonce-a-day tablet whichits marketers say sup-pressed the hepatitis Bvirus more rapidly andprofoundly than the estab-lished drug, GSK’s Zeffix(lamivudine).

Despite strong resultsagainst Zeffix in itsGLOBE study, the biggestbattle for Sebivo will be incompeting against severalother new entrants into themarket.

Currently there is nocure for hepatitis, and all

existing treatments workby suppressing the repli-cation of the virus withinthe body. Patients takingZeffix eventually developresistance to the drug, butthe main advantage of newtreatments is that thiseffect is seen much later.

Roche’s Pegasys is anewer product which hasbeen on the market forsome years and is nowfirmly established, butBMS’ Baraclude could bethe brand to beat in themarketplace.

Baraclude was launchedin markets across Europein autumn 2006 by Bris-tol-Myers Squibb, andanalysts say its potencyand resistance profile,compared to Zeffix, couldmake it the treatment ofchoice.

Every year in Europe, an

estimated one million people areinfected with the hepatitis B virus.

Of these, 90,000 will becomechronic carriers and 24,000 will diefrom either cirrhosis or liver cancer.

“Chronic hepatitis B is a veryserious disease affecting more than350 million people worldwide and agrowing public health problem inEurope,” said Jean-Pierre Somma-dossi, Idenix’s chairman and chiefexecutive. “As no cure currentlyexists, a primary goal of treatmentis to reduce the amount of virus inthe blood quickly and for as long aspossible in order to improve long-term clinical outcomes.”

He concluded: “We are assem-bling a strong commercial team in

Europe and look forward to work-ing with Novartis to make Sebivoavailable to European patients assoon as possible after it is formallyapproved.”

The disease is caused by thehepatitis B virus (HBV), whichattacks liver cells and can lead toliver scarring (cirrhosis), liver can-cer and liver failure or death.

HBV is 50 to 100 times moreinfectious than human immunode-ficiency virus HIV. The incidenceof hepatitis B ranges from 29 casesfor every 100,000 people in West-ern Europe to 523 per 100,000 inEastern Europe.

The drug is already approved inthe US (where it is known asTyzeka), Canada, Switzerland andvarious other countries in Asia andLatin America. An application formarketing approval is pending withthe Chinese health authority.

Novartis and Idenix will co-pro-mote Sebivo, (and two otherhepatitis drugs in the pipeline: val-torcitabine and valopicitabine) inthe US, France, Germany, Italy,Spain and the UK.

Novartis has the exclusive right tocommercialise Sebivo, val-torcitabine and valopicitabine in therest of the world.

New hepatitis B treatment Sebivo set for European approvalEuropean Product News

The pharmaceutical industry is not theonly one where relations between globalhead offices and national operations

need expert co-ordination. For example, takethe automotive, food or hotel sectors. Ask anyexecutive working in them about their globalhead office and they will almost certainly tellyou that colleagues located in New York,Tokyo, or Sydney don’t always understand theissues they face in London, Frankfurt orMadrid.

Yet, the issue is especially acute in thepharmaceutical industry. This is because it isthe responsibility of the international team todrive new products to market. Nationalcompanies are there to launch, market, andsell existing products, and they rely on theirinternational colleagues to deliver theresearch, development and registrationstrategies for their new products. Globally co-ordinated campaigns are thereforefundamentally important in this industry.

However, in the past few years, things havestarted to change. We have seen a shift fromglobal campaigns to regional campaigns. Thishas been reflected in the increasing emphasis

given by many leading pharmaceuticalcompanies to their regional head offices inthe US, Europe and South East Asia. To alarge extent, Europeans share a culture and aregulatory framework, and, as they come torecognise this, so more and morepharmaceutical companies are developingpan-European pre-launch medicalcommunications campaigns.

While pan-European campaigns may bemore targeted than global campaigns, they arestill challenging to design and implement.They require a great deal of experience inmedical communications, a clearunderstanding of the reasons for taking a pan-European approach, and, perhaps more thananything else, an awareness of the potentialpitfalls, and how to avoid them.

A wider European market

Few campaigns are truly continent-wide. Inmost cases, pan-European campaigns arefocused on the key markets – the UK, France,Spain, Italy and Germany – but companiesare increasingly investing in othersophisticated markets, such as Scandinavia,

and beginning to explore the potential of thethriving Eastern European economies.

These campaigns are most commonlydeployed in the critical few years running upto launch. Typically, a company will beginthese campaigns once it is confident itsprospective new product will progress tophase III. How far away this is from launchvaries depending on the therapeutic area.Oncology and HIV drugs are often fast-tracked through the approval process and sothe pre-launch phase in extreme cases mayonly be a matter of months, while for mostproducts this is likely to be around four yearsfrom launch.

The target audience

The first stage is to identify the core group ofpan-European level stakeholders who will beinvolved, to a greater or lesser extent in theapproval of the new drug. Typically, these willinclude leading physicians with aninternational profile, and pan-Europeanpatient advocacy groups.

For example, for one of its clients inophthalmology, Edelman worked on a summitthat brought together national advocacygroups, leading physicians and politicians todevelop a global consensus as well as nationallevel action plans aimed at addressing age-related macular degeneration. The eventallowed stakeholders from across Europe todiscuss the relevant issues and to presentthem in a ‘call to action’ to the members ofthe European parliament and other keystakeholders in their local countries (see boxon next page for more details).

Once the pharmaceutical company, togetherwith its medical communications agency, hasidentified its target audience, the objective ofthe campaign is simple: to build the mostpositive reputation for the new product bymaking these people aware of it, the benefitsit will bring, and why these are important.

Although the objective is simple, attainingit is less so. It involves a complex range ofinteractive, offline and online activities.These include communicating datamilestones through the medical media,producing communications materials for keytriallists, organising symposia and meetingsat which spokesmen can talk about the highscience surrounding the product as well as

discussing its practical application, runningadvisory boards and smaller discussiongroups where the company and experts canexplore fully the dynamics of the market, thedisease area and how the new product willhelp, and then finally, writing up theseactivities where appropriate and publishingthem, for example, online or as a supplementto a peer-reviewed medical journal.

Just before launch, the pan-European teamwill usually hand over the relationship withthese key stakeholders to the national medicalcommunications teams so they can build at anational level on the foundations laid by thepan-European team in the run-up tolaunch.However, post-launch there is stillwork to be done on a pan-European scale. Itcan be challenging, since it is easier to talkabout the new than the current, but a majorfocus of post-launch campaigns typicallyinvolves developing existing products for usein new indications and for new patientpopulations.

For example, while the nationalcommunications team is launching andmarketing a product that was initiallyproduced to assist with hypertension, the pan-European team might be conducting researchinto its possible use as a treatment for heartfailure. While it was proving its value in thisnew area, the company would need to mapout new key stakeholder groups and startbuilding relationships with those physiciansand patient groups.

Reaping the benefits of pan-European campaigns

To a large extent these campaigns must beconducted on an international scale. For onething, no company has the resources toconduct all of this development work, muchof which is speculative, on a national basis.For another, new product licences areincreasingly applied for at a regional, EUrather than national, basis.

However, above and beyond thesenecessities, pharmaceutical companies canreap significant benefits from runningsuccessful pan-European campaigns. Thefirst is regional consistency of message andstrategic co-ordination. The teams in the UK,France, Spain, Italy, Germany and elsewherewill all be referring to the same core package

14

SuccessfulEuropeanmed comms

Embrace similarities andrecognise differences toproduce the bestmarketing campaigns, saysMike Kan



On 8 January, 2007, Pfizer

announced that the

European Commission had

granted full marketing

authorisation to cancer

treatment Sutent for first line

use in metastatic renal cell

carcinoma. The drug is the

first and only multiple

receptor tyrosine kinase

inhibitor to have been

approved in this setting.

Edelman’s role was to

gain pan-European

coverage of this event,

publicising it through media

briefings and pre-pitching to

outlets that had previously

covered Sutent stories at the

American Society of Clinical

Oncology (ASCO).

Edelman had already

delivered substantial media

coverage for Sutent at

ASCO, including 440 unique

media stories, more than

470 million media

impressions, broadcast

coverage in 14 countries,

and Scrip hailed Sutent as

winning “the kidney cancer

crown at ASCO”.

For the marketing

authorisation, Edelman held

individual briefings with

Reuters, Bloomberg,

Associated Press, APM,

Dow Jones and AFX

International. This resulted

in media coverage across

more than 90 outlets.

Seventy per cent of the

media coverage contained

Sutent’s top three key

messages and 100 per cent

of the coverage was

positive.

Case Study 1: Pan-European media relations support

Ge

tty

of scientific data, using the same architecture ofkey messages, and presenting a strategicallyunified, coherent positioning of the product.

The second benefit is economies of scale onintellectual property. It is highly likely that each ofthe teams in those national markets will beencountering the same issues with a new product,and so the pan-European communications teamcan provide collateral that will help all of themaddress these issues.

For example, when one of our clients wasworking with an international patient organisationon depression, they conducted a survey in 10countries on key depression issues. The same set ofquestions was asked across all 10 countriesallowing for consistent country comparisons to bemade. They were able to launch the results at aninternational congress and then give them to thenational teams to use in their own mediacampaigns. It was not only a less expensivesolution than having each country conduct its ownresearch, it was also more effective.

The third potential benefit of pan-Europeancampaigns is that they provide a good opportunityfor skills training and coaching. The smallerEuropean countries often lack the medicalcommunications expertise and resources of thefive largest countries, but by operating a campaignacross the continent, a company can ensure thatskills are transferred and the product has thegreatest potential to succeed in every nationalmarket.

Finally, having a pan-European team taking careof the future allows the national teams to devote alltheir energies to the present. They can focus onselling and marketing their existing product range,confident in the knowledge that their internationalcolleagues are researching, developing andregistering new products and new uses for existingproducts.

Communication all the way

A properly designed and executed pan-Europeanmedical communications campaign can make thedifference between the success and failure of a newproduct. There is, however, much that can gowrong and it is wise to be aware of as many ofthese potential pitfalls as possible.

The most common issue that arises with thesecommunications campaigns is, ironically enough,a lack of communication between the internationaland national offices. The pan-European team mayfail to keep its colleagues at the national levelupdated on developments and key milestones.

Similarly, the international team can beenthusiastic to start promoting a product to a newaudience, while the national team is still strugglingto establish it with the original target audience.Again, it is about communicating effectively andjointly, setting key milestones for reviewing theprogress a product is making and examining howeveryone can work together to progress it.

We work with our clients to hold regulargatherings of all the executives involved in medicalcommunications. These are typically one or twodays’ long and give everyone a chance to explainthe progress they are making and to find out abouthow their colleagues at national or internationallevel are faring. There is usually a presentation ofinternational strategy followed by break-outgroups and workshops where smaller groups candiscuss their issues and agree effective stepsforward.

Finding help and support

While the benefits of pan-European campaigns faroutweigh the downsides, there are potential pitfallsto beware of. We would always recommendcompanies to work with an agency that has averifiable track record of success in thesecampaigns. That agency will be able to help theclient steer a safe course through these pitfalls toensure that the campaign is a success.

In Edelman’s experience, whenever the rightteam embarks on a pan-European medicalcommunications campaign, with a well-plannedstrategy and proactive buy-in across theorganisation, the campaign contributesenormously to the successful marketing of aproduct.

Mike Kan is UK Managing Director, Edelman

Health. For more information e-mail

[email protected] or visit

www.edelman.co.uk/expertise/health/

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One of our clients in the

ophthalmology area wished to

support an international patient

organisation which was taking

action to address the growing

public health burden of age-

related macular degeneration

(AMD).

Edelman worked with the

client and the patient group to

design and implement a two-

day summit. The event was

held in partnership with the

global patient advocacy group,

AMD Alliance International, and

brought together national

advocacy groups, leading

physicians and politicians to

develop a global consensus as

well as national level action

plans to address the growing

crisis of AMD. The outputs of

the event were presented to the

media at a separate press

briefing held during day two of

the conference.

The delegates were able to

identify the key priorities to be

supported by governments,

consumer groups and medical

professionals

The conference allowed

stakeholders from across

Europe to discuss the relevant

issues and to present them in a

‘call to action’ to the members

of the European parliament and

other key stakeholders in their

local countries.

The event was attended by

80 delegates from 21 countries

across the globe, and 24

journalists attended the

accompanying press briefing.

Robert Madelin, the most

senior health official in the

European Commission,

delivered a keynote speech

and letters of support were also

received from national

governments.

The messages are still

continuing to resonate beyond

the conference because it

involved a wide range of

stakeholders – which included

physicians, advocacy groups,

politicians, media and industry,

– and ensured that the event

provided value for each of

them.

Case study 2: pan-European advocacy group partnership

AMD is a leading cause ofblindness in Europe

Pharmafocus a Wiley publication16

Synovateopens firstGerman office

Research firm settles

on Hamburg

(back page)

Appointments

The latest movers and

shakers

(p18)

Merck Seronoexamines itsagency options

Integration efforts

include a review of

agency use

(back page)

Surge of interest in European MBAs The number of business schools in Europe offeringMBA programmes has dramatically increased sincethe 1990s.

Last year, 658 European business schools offeredthe qualification, up from 181 in 1999, a testiment tothe strong student demand in the region for the MBAqualification.

The US-based Graduate Management AdmissionCouncil (GMAC), which provides the most widelyused assessment for graduate management admis-sions, said 65% of full-time programmes reportedthat application volumes increased last year. Thiscompared with just 21% of business schools in 2005and 19% in 2004.

“There is a brilliant bloom on the MBA rose,”GMAC chief executive David Wilson commentedwhen the admission results were released last year,

adding that the demand for places on all types ofMBA programmes in countries around the world isgrowing.

It is the first time since the early 1990s that anincrease in MBA applications has coincided with ahealthy job market for graduating students. Europeanbusiness schools are among those to benefit – 15 ofthe top 50 institutions were European according toThe Financial Times MBA 2007, a survey of the top100 full-time MBA programmes around the world.

The schools were ranked according to an audit car-ried out by managment consultants KPMG. This wasbased on information supplied by alumni of theclasses of 2001, 2002 and 2003 on their salaries andsalary increases three years after graduation.

Students who graduated from one of the top 10global business schools reported an average salary of

$148,609 three years after finishing their course andtheir average salary increased some 127% in theyears between starting the MBA and the three yearsafter graduation.

The audit’s first four places were held by institu-tions from the US – the traditional heartland forMBA programmes.

Top among Europeans was the London BusinessSchool, which has held its fifth placing among globalMBA programmes for the past three years. It wasjoined in the top 10 global institutions by France’sInsead, which recently reported its largest ever MBAclass intake.

Both regions have strong competitions from emerg-ing areas like India – where there are now morebusiness schools than in the US – and China, whichis also seeing continued growth.


Prospective MBA students are being invited to applyfor one of five European leadership awards nowbeing offered by European business school CranfieldSchool of Management in the UK.

The newly announced awards are each worth£10,000 – approximately €15,000.

Successful candidates will be able to use the awardstowards paying for Cranfield’s full-time MBA start-ing in October 2007, or the executive (part-time ormodular) MBA programme starting in January 2008.

To qualify for one of the awards, applicants must bea national of Norway, Switzerland or one of the EUcountries (excluding the UK). Other nationalities res-ident in these countries or candidates sponsored bytheir organisation will not be eligible to apply.

To win an award, candidates must go through thenormal admission process for the Cranfield MBAand possess:

• a good first or second class honours degree or equivalent

• at least three years’ postgraduate work experience• a high GMAT score* (the average at Cranfield is

660). Anyone able to go to Cranfield for interview,may take the Cranfield admission tests as an alter-native to GMAT.

To apply, visit www.cranfield.ac.uk/som/mba andcomplete the MBA application form and submit it nolater than 30 April, 2007.

In addition, to be eligible for consideration for theaward, candidates are required to submit an essay ofno more than 1,000 words answering the question:“Which European leader do you admire, and why?”Suitable candidates will be invited to attend an inter-view at Cranfield during May 2007.

The award winners will be notified of the outcomeof their application and essay in June 2007.

To find out more about the Cranfield MBA, poten-tial candidates can attend one of several preview daystaking place at Cranfield this year.

The dates are 2 March, 21 April, 18 May, 30 June,21 September, 27 October and 20 November. Visitwww.cranfield.ac.uk/som/mba/preview

Cranfield offers EuropeanMBA leadership bursary

University of Pennsylvania: Wharton USA

Columbia Business School USA

Harvard Business School USA

Stanford University GSB USA

London Business School UK

London Business School UK

Insead France/Singapore

Instituto de Empresa Spain

IMD Switzerland

University of Cambridge: Judge UK

lese Business School Spain

HEC Paris France

University of Oxford: Said UK

Manchester Business School UK

Esade Business School Spain

Lancaster University Management School UK

RSM Erasmus University Netherlands

Warwick Business School UK

Cranfield School of Management UK

SDA Bocconi ItalySource: Financial Times MBA 2007

London Business School

Top five global MBA programmes

Top 15 European MBA programmes

The latest on careers andappointments, marketingand communication newsfrom InPharm.com

coming soon...


Advertising contactsRyan MurrantRecruitment Account ManagerTel: +44 (0)1483 515341E-mail: [email protected]

Greg HoltGroup Recruitment & On-line Commercial ManagerTel: +44 (0)1483 515311E-mail: [email protected]

17Pharmafocus Europe a Wiley publication

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Otsuka Europe has appoint-ed Meguru Kajiwara asmanaging director.

Mr Kajiwara, who has a de-gree from the ScienceUniversity of Tokyo, joined Ot-suka in 1978 as a medical rep.Since then, he has held sever-al senior roles, includingbranch manager Nigata andSendai region of Japan, gen-eral manager Otsuka Taiwan,and managing director OtsukaInternational Arab and Asia(OIAA). As a result, he bringsto his new role 28 years’ expe-rience of the Asian market.

Otsuka is a network of 87 in-ternational companies andhas its headquarters in Tokyo,Japan. The company employs27,000 people worldwide andhas 29 research centres. ItsEU office, where Mr Kajiwarawill be based, is in London.

Pharmafocus asked Mr Kaji-wara about his new role:

What attracted you to work-ing in Europe?

When the prospect of heading

up Otsuka’s European opera-tion presented itself, I felt itwas the ideal opportunity toconsolidate my 28 years of ex-perience in Asia, to help shapeOtsuka’s European business.

I was drawn by the challengeof working in Europe whereOtsuka is experiencing signifi-cant growth, quite similar tothe development currently tak-ing place across Asia Pacific.

Twenty-seven different health-care agendas, all reformingtowards a common EU healthpolicy, makes for a very inter-esting time to operate inEurope, especially as a foreignpharmaceutical company.

Otsuka has a unique Japan-ese/European business modeland the flexibility of this has al-lowed us to ‘get back tobasics’ in what is a tough op-erating environment.

What have been the high-lights of your career so far?

I very much enjoyed workingin Taiwan as it was during aperiod when the country wasjust starting to emerge as a se-rious player within Asia andthe pharmaceutical sectorthere was experiencing signifi-cant growth.

When I later joined OIAA, mytarget was to double sales inthe region within five years,but thanks to the support andhelp of the specialist product

managers in the different mar-kets, I was able to achieve thisgoal within four years, whichwas very satisfying.

What are your aims, longand short-term?

In the short-term, I intend tocontinue to build on the solidinfrastructure Otsuka has es-tablished in Europe and on ouralliances with key partners,such as Bristol-Myers Squibb.

Looking further ahead, wehave plans to introduce amore diverse ‘nutraceuticals’portfolio into Europe.

Otsuka is a company whichlooks to develop products inareas of high unmet need,rather than simply concentrat-ing on potential blockbusters,and the policy will be to bringmore innovative medicinesand devices to the Europeanmarket.

What is your golden rule inbusiness?

I believe there are three keyfactors for business success –accountability, communicationand transparency – and thesewill become even more impor-tant in the future.

Specialist healthcare PRconsultancy, hsdcommuni-cations, has appointedCosima Zerdik as accountexecutive in its medical com-munications division.

Cosima, who is fluent inEnglish, German andFrench, works on the compa-ny’s international businessfor Mölnlycke Health Care,Bard, Reckitt Benckiser, andAchive.

Cosima has worked inproduct management atJohnson & Johnson Medicaland Pfizer, where she wasresponsible for products invascular access and oph-thalmics.

She graduated from theVienna University ofEconomics and BusinessAdministration with a Mastersin international commerceand from the CEMSProgramme with a Masters ininternational management.She is currently pursuing aPhD in business history.

Rachael Pay has joinedWeber Shandwick as man-aging director of its Europeanhealthcare practice.

Pay, who most recentlyserved as managing directorat Euro RSCG Life PR inNew York, will report to LauraSchoen, president of WeberShandwick global healthcare,and Colin Byrne, CEO of U.Kand Ireland.

Pay has worked in health-care public relations for morethan 15 years in the U.S. andEurope.

ThromboGenics NV hasmade two senior appoint-ments.

Dr Patrik De Haesbecomes chief operating offi-cer and Dr Franky Terras isappointed as patent counsel.

Prior to joiningThromboGenics, Dr De Haeswas senior vice presidentand head of the global infu-sion business at RocheDiagnostics, and a memberof the executive committee ofRoche Diabetes Care.

Before this, and until itsacquisition by Roche, he waspresident and chief executiveofficer of Disetronic MedicalSystems, Minneapolis,Minnesota, USA.

De Haes has also heldsenior positions in pharma-ceuticals with SandozPharma (now part ofNovartis.

Dr Terras has spent morethan seven years as a patentcounsel for a number ofbiotechnology companies.

Before joining Thrombo-Genics, he was patent coun-

sel at Innogenetics in Gent,Belgium. He was previouslyintellectual property liaisonofficer at CropDesign (nowpart of BASF), Gent,Belgium.

Dr Marc Cluzel has beenappointed as senior vicepresident, science and med-ical affairs at Sanofi-Aventis.He succeeds Gérard Le Fur,who has been named chiefexecutive officer.

Dr Cluzel joined SanofiRecherche in 1991 within theclinical development depart-ment, and was appointedsuccessively senior projectdirector in 1993, vice presi-dent, research projectsmanagement in 1996 andvice president, internationaldevelopment in 2001. Since2005, he was senior vicepresident, international devel-opment.

Dr Jean-Philippe Santonisucceeds Marc Cluzel assenior vice president, interna-tional development. He willmanage the developmentactivities on a worldwidebasis.

Dr Santoni joinedSynthélabo in 1990 as car-diovascular developmentdirector and, in 2001, wasappointed vice president,international clinical opera-tions, Sanofi-SynthélaboResearch. Since 2004, hewas vice president, interna-tional clinical development forSanofi-Aventis.

Appointments

MMeegguurruu KKaajjiiwwaarraa

Venue Guide 2007FOR HEALTHCARE MEETINGS AND CORPORATE EVENTS

Pharmafocus

If your company has made a new appointment and you

would like it to be included on our next Appointments

page, please send details and an accompanying photo

by email to: [email protected]

AM-Pharma BV, the biophar-maceutical company whichdevelops novel drugs to treatinfectious and inflammatorydiseases, has appointed BartWuurman, as chief executiveofficer.

Bart has 18 years of inter-national pharma and biotechexperience with Organon,Medeva and Antisoma, wherehe was responsible for a$500 million oncology alliancewith Roche.

In 2003, Bart became chiefexecutive officer of De NovoPharmaceuticals, Cambridge,UK, where he successfullyimplemented a restructuringand refinancing strategy.

Dr Andreas Busch and DrKemal Malik have beenappointed to the board ofmanagement of BayerSchering Pharma. They willalso become members ofthe Bayer HealthCare exec-utive committee.

Dr. Busch is currentlyhead of global drug discov-ery at Bayer Schering

Pharma. He joined BayerHealthCare in 2005, wherehe was head of discoveryEurope for the pharmaceuti-cals division in Wuppertal.

Dr. Kemal Malik is current-ly head of global develop-ment and chief medical offi-cer at Bayer ScheringPharma.

He joined Bayer in 1995as head of metabolism andoncology Europe. He subse-quently served as head ofglobal medical developmentbefore being appointedhead of global developmentand compliance.

Elbion NV, a specialty phar-ma company with a focuson neurology and immunolo-gy, has appointed DrKoenraad Blot as chiefmedical officer. Dr Blot has15 years’ international phar-ma experience and willoversee Elbion’s clinical pro-grammes and regulatoryfilings.

Dr Blot was previouslyexecutive director, clinicalresearch at Theratechnolo-gies, Montreal, Canada,where he led the clinicalresearch division. Prior tothis, he held several posi-tions at Pfizer in scientificaffairs, medical operationsand clinical research inCanada, USA and Belgium.

His background is in phar-maceutical developmentand operations, curativemedicine and public health.

18

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Merck Serono is conductinga review of the communica-tions agencies it uses inEurope as parts of its effortsto integrate the different areasof the business.

Germany’s Merck KGaAformed the biopharmaceuti-cal company last Septemberthrough its $13.5 billionacquisition of Swiss biotechSerono.

A spokesman told Phar-mafocus: “We are certainlymaking progress to integrateour two companies in the UKand wider Europe.

“There are several therapeu-tic areas we are looking at andit is quite reasonable to recog-nise that there may be somepossibilities for re-arrange-

ment of agencies.”The spokesman would not

say how many PR or advertis-ing agencies the newcompany presently had on itsbooks, but added: “We have along-term relationship with anumber of agencies and it isabsolutely routine when amerger occurs to reflect onthe agencies you have.”

The company has recentlyappointed two agencies in theUK, including a communica-tions partner for its multiplesclerosis risk-sharing pro-gramme.

The programme waslaunched in 2002 in a bid toincrease patient access to MSdrugs with a contract betweenthe UK government and four

pharmaceutical companies.This put reimbursement on asliding scale depending onhow well patients responded

to treatment.As well as Merck Serono,

the 10-year scheme involvesSchering Health Care and

Biogen, (all of which manu-facture beta interferonproducts) and Teva, the manu-facturer of Copaxone (aglatiramer product).

Merck Serono hasappointed RoundhouseHealthAd to work on a rangeof educational and profes-sional development servicesfor healthcare professionals.

Merck Serono’s UK generalmanager Don Cowling said:“This really is new territorywhere we have activelyengaged with the Departmentof Health to recognise thatour responsibilities as a man-ufacturer extend beyondsimply supplying a drug.

“We have set up a steeringgroup who will advise which

KnowledgeGenerationsfor

WileySince1807...

Merck Serono examines its agency options across Europeareas our support will mostpositively impact qualityof patient care”.

The project will initiallyrun for 18 months andclosely monitor the linkbetween services and mate-rials delivered into thehealthcare system and thesubsequent outcome onimproved standards of care.

Mr Cowling added: “It iscritical that we get this rightfrom the outset. This is asignificant investment, notonly for Serono but also forthe Department of Health.We have a responsibility toensure that the servicesprovided under this initia-tive actually achieve whatthey are intended to

deliver”.Roundhouse managing

director Kevin McGetricksaid the agency was enter-ing uncharted territory inengaging in an active part-nership with healthcareprofessionals, but that themove will allow it to bringtogether all the skills con-tained across its parentgroup Adventis.

Merck Serono alsorecently appointed PRagency Huntsworth Healthto manage a new UK com-munications campaign forits blockbuster Gonal-f,which supplements orreplaces naturally occur-ring hormones in womenwith fertility problems.

Specialist healthcare mar-ket research companySynovate Healthcare is toopen a new office in Ham-burg to expand its reachinto Germany, Europe’sbiggest pharmaceuticalmarket.

Synovate HealthcareGermany will offer ad hocservices for domesticclients, international pro-jects for Germanmultinationals and localaffiliate services for Syno-vate Healthcare’ssyndicated portfolio.

The setting up of a dedi-cated healthcare team inGermany is part of thecompany’s plans todevelop its presence in thatmarket, which has untilnow been run from otherEuropean sites, and fromthe US and Asia.

Spearheading the com-pany’s German operationsis Manfred Eberlein whohas been appointed coun-try manager, SynovateHealthcare Germany.

Eberlein was formerlydirector of Ipsos Insightand has 18 years’ experi-ence in both consumer andhealthcare market research.

Eberlein is joined byTorsten Brockmeyer, also

from Ipsos Insight Health,who brings to the team astrong track record in mar-ket research and medicine.

Eberlein, commenting onthe German service, said:“This is a really excitingmove, both for myself andfor the company.

“Synovate Healthcare hasestablished a strong reputa-tion within the industryand I look forward tobuilding on the great workalready conducted.

“In addition to healthcareexpertise, we have accessto some truly ground-breaking researchdevelopments from Syno-vate; I look forward tobringing these to the Ger-man pharma market”.

Synovate opens itsfirst German office

Grey Healthcare Group hasadded the Madrid-basedadvertising agency, Comu-nicacion y Servicio, to itsglobal network.

Comunicacion y Servicio(CyS) will continue to beled by general managerJosé Antonio Alguacil, whosaid he was confident thedeal would quickly bringbenefits to the clients ofCyS and Grey.

“This is an exceptionalopportunity for us to joinforces with a global com-pany that is focusing ontaking healthcare commu-nications to the next levelof interactivity and sophis-tication,” he added.

Founded in 1997, CySemploys 16 people and itsclients include Bristol-Myers Squibb, Pfizer,GSK, Schering-Plough,Abbott Laboratories and

Boehringer Ingelheim.In 2005, revenues at the

independent agencyreached €4.3 million and ithad gross assets of €1.5million.

Chief executive of GreyHealthcare Group (GHG)Lynn O’Connor Vos said:“CyS is one of the topagencies in Spain and itsreputation for creativeexcellence and strategicthinking is unmatched. Thisacquisition will help usexpand our clients’ busi-ness in Spain, and acrossEurope, and continuesGHG’s strategy of develop-ing networks in importantmarkets and services.”

GHG is one of the topfive healthcare groups inthe world, with 42 officesin 21 countries, and is partof the WPP communica-tions services group.

Grey acquires Spanishadvertising agency CyS

Elmar Schnee, Merck Serono’s new chief executive

Manfred Eberlein



Pfizer Strikes Back Spring 2007 Pharma on the back foot as … Europe_Mar 07.pdf · 2007-03-29 ·...

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