Strategic Implications of Clinical Research for Generic Companies Dr Sohail Manzoor

8/6/2019 Strategic Implications of Clinical Research for Generic Companies Dr Sohail Manzoor

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Dr Sohail ManzoorDirector Medical & Regulatory Affairs

Hilton Pharma

Strategic Implications of Clinical

Research for Generic Companies


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In all affairs it is a healthy thingnow and then to hang a question

mark on the things you have longtaken for granted.

-Bertrand Russell


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Pakistan 664 Pharma Companies

634 National companies

30 MNCs

212 national Pharma companies arerepresented by the PakistanPharmaceutical manufacturersAssociation (PPMA).

400 Pharmaceutical Manufacturingplants 370 national Pharma Companies

30 MNCs


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86 Billion PKR Market

84%

16%

Top 50 Companies

Others

84% market share = 72 billion PKR

Among top 50 companies 30 are National companies


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86 Billion PKR Market

94%

6%

Top 100 Companies

Others

94% market share = 80 Billion PKRAmong top 100 companies 70 are National Companies


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Market ShareMNCs vsNational

0

10

20

30

40

50

60

70

1999 2000 2001 2002 2003 2004 2005 2006

MNC's National


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Pakistan

Per Capita drug spending is 8 US $ (488 PKR).

Pakistans population is 2.4 % of worlds Population

Share of the Global Pharmaceutical market is 0.31 %

40,000 brand names are registered comprising of1,400 molecules. 28 : 1

Diclofenac sodium 98 Brands

Omerprazole capsule 86 Brands

Ciprofloxacin tablet 84 Brands


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Generic Market (Gx) A REALITY

The quality of generics manufacturers production has improved

dramatically, and these companies are far larger moresophisticated

The rise in health-care costs means that even in developedmarkets, generic drugs will become increasingly popular andthat in emerging markets they will be a key to gaining a broaderpresence.

Finally Rx companies are facing a well-known shortfall ininnovation as Gx companies are beginning to expand intoinnovative activities cost-effectively.


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Generic Market (Gx) ---- A REALITY

Of the 3.5 billion prescriptions written inthe U.S. in 2004 56% were for generic

drugs a fourfold increase in last 20years .

Worldwide, $45.2 billion of genericdrugs were sold in 2004.


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Why The Need

According to the WHO 14 million people dieeach year from communicable diseases

Malaria TB

Sleeping sickness

kala azar

For which treatment options are inadequateor do not exist, and for which R&D isinsufficient


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Why the NEED

About 97 % of deaths from communicable diseasesoccur in developing countries.

Infectious and parasitic diseases account for 25 % ofthe disease burden in low- and middle-incomecountries compared to only 3 % in high-incomecountries.

Eliminating communicable diseases would close themortality gap between the richest 20 % of the worldpopulation and the poorest 20 % ( World Bank report)


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Market Failures

Over the last few decades major progress inmolecular biology and biotechnology has enabled thedevelopment of increasingly sophisticated medicines

to cure a wide variety of diseases.

Meanwhile, global expenditures on health R&D hasincreased dramatically, R&D funds are focused on

diseases of the rich. Only 10 % of global health research is devoted to

conditions that account for 90 % of the global diseaseburden -- an imbalance that has been referred to asthe 10/90 disequilibrium.


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80/20

People in developing countries, who make upabout 80 % of the world Population, only

represent about 20 % of worldwide medicinesales.

All of sub-Saharan Africa totals less than 2percent of the global pharmaceutical market.


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Possible Issues !!

Current reality is majority of registration trials arefocused on the United States and Europe.

Pattern of disease in our population is different from

that of the US / European population !! Disease characteristics in Asian patients may be

different from those seen in white patients!!

This is particularly evident in breast cancer.

In Singapore Women Peak incidence of breast cancer in their40s In United States, the peak incidence is in women in their60s.

Postmenopausal patients in Singapore 47%

Postmenopausal patients in USA 80%

Less hormone-receptor-positive tumors in Asian women


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Differe P r k k ine ics !!!!

How the body handles drugs may be different inAsian patients compared with white patients !!!

different metabolic rates and geneticvariations

The acetylation of drugs 80% of Asians are Fast acetylators

60% of Whites are Slow acetylators.

Body size difference

Difference in diet/alcohol P450 Enzymes


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Dose Difference !!!???

This study demonstrated interethnicdifferences in myelotoxicity with doxorubicin

and cyclophosphamide in breast cancerpatients. Higher portion of Singaporean patients 55%

experienced severe myelotoxicity vs. 20 %Australian patients.

Beith JM, Goh BC, Yeo W, et al. Inter-ethnic differences in the

myelotoxicity of adriamycin/cylophosphamide (AC) for adjuvant breastcancer.of the American Society of ClinicalOncology 38th Annual Meeting, May 18-21, 2002; Orlando, Florida.


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Local Normal Ranges !!!

Do we know what is the average HB ornormal range of HB is among our population.

We follow 12-15 Mg HB range of westernfemale population

Where they have a birth rate ranging from 0to 2 per women as compared 5.4 births perwomen in our country !!!

Can the HB range be SAME !!!!! ?????


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Regulatory Requirement

Now Our regulatory authorities haveadvised for all new product

registrations--- to submit Post MarketingSurveillance (PMS) report.


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Export Potential

Central Asian states, Africa and middle east hasnumber of requirements for registration eg PSUR,Bioeqvilance & PMS.

Pakistan Medicine exports are about 60 million US $

India Medicine Exports are

570 Million US$

Clinical Trials with Generic products will makeregistration FASTER in export market.


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HCV -Pakistan

Approx.10 million HCV patients

Treated with Interferon Alfa TIW with Ribavirin for sixmonths.

Interferon alfa half life of 6 hours given TIW withweekend OFF---- Effective Drug levels notMAINTAINED to supress HCV virus.

Peg interferon once a week maintains DRUG LEVEL

through out the week. Cost difference 312000 PKR vs 60000 PKR ( 5 : 1)

A study with DAILY DOSE of standard interferonshowed a better response of 94% as compared to

78 % with Peg interferon.


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Clinicalstudies Benefits !!

Usually Peg interferon alfa 2 a180 microgramis used--- some Gastroentrologists suggest

its 90 Microgram also gives SAME result withHalf the cost.

Daily Dose standard Interferon study for OurHCV patients -- if positive can save money

and along with giving a better result for ourpatients.


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Clinicaltrials

Phase 4 studies with a generic moleculewill help to DIFFERENTIATE , More

EVIDENCE BASED Proof of QUALITY& EFFICACY confidence to theprescriber.

A Generic drug with ITS OWN clinicaldata will be EASY to Sell.


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Need

Now most doctors ask for LOCAL data

Now more doctors WANT to do Clinicalstudies.

Now More National companies haveMEDICAL departments


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Business & Science

Actually Business RULES the Science inreality.

But GOOD Strategic science if thought &implemented properly can make the Businessto INVEST in science to get more business.

National Companies should INVEST more in

local studies to Find answers for betterlogical,quality and economical treatment---allthis will definitely Increase Business---due toLocal evidence based science


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Clinical studies

Clinical studies will find out about

Hb ranges

Dose requirements

Side effects profiles Based on such information NATIONAL TREATMENT

GUIDELINES for various diseases can be made forbetter patient care.

This can be the most Ethical WINNING MedicalMarketing toolfor the national Pharma companies.


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Strategic Implications of Clinical Research for Generic Companies Dr Sohail Manzoor

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