Corporate Presentation October 2007kundeweb.aggressive.no/users/algeta.no... · Cancer is a major...

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Algeta ASA Company Presentation October 2007

Transcript of Corporate Presentation October 2007kundeweb.aggressive.no/users/algeta.no... · Cancer is a major...

Page 1: Corporate Presentation October 2007kundeweb.aggressive.no/users/algeta.no... · Cancer is a major disease Algeta’s lead program targets skeletal metastases from prostate cancer,one

Algeta ASA

Company Presentation

October 2007

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Algeta summary

• Exclusive focus on cancer therapeutics

• Lead product AlpharadinTM due to enter phase III in 2008

• Oslo Stock Exchange listing in March 2007

• Excellent international life science investor base

• Experienced management and Board

• Platform technology – unique tumour targeted alpha-emitters

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Highlights first half 2007

• NOK 250 million raised in IPO in conjunction with listing on OSE– Attracted a significant number of international life

science investors– Solid financial position to support clinical & pipeline

investments

• Algeta is benefiting from increased visibility and recognition– Positive Alpharadin clinical data from Phase II trial completed

in Q1 2007• Data presented at ASCO Annual Meeting (June 2007)• Published in July 2007 issue of Lancet Oncology and in June

online edition

– Pre-clinical project; TH-1 paper published in Blood

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Cancer treatment options

ChemotherapySurgery Radiotherapy

Traditional:

Algeta’s technology:

Targeted internal radiotherapy

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Cancer is a major disease

Algeta’s lead program targets skeletal metastases from prostate cancer, one of the most common cancer types

Source: WHO, World Cancer Report 2003

150,000

200,000

250,000

300,000

350,000

400,000

450,000

500,000

2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050

Prostate

Breast

Lung & Bronchus

Colon

Number of New Cases

Projected new cancer cases (US) Estimated new cases of cancer and deaths (US)

Estimated deaths 2007

Estimated new cases

2007

213,380

218,890

15,28022,430Ovary

160,390Lung & bronchus

40,460178,480Breast

27,050Prostate

Source: Prostate Cancer Foundation

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Algeta’s product pipeline

Algeta’s product pipeline comprises different technologies to deliver alpha particle emitters to treat cancer

Skeletal metastases from breast cancer

AlpharadinTM

Development phaseIndicationProduct pipeline

Research Preclinical

Phase I

Clinical development

Phase II Phase III

Soft tissue tumours

Intracavitary cancer

Various cancer indications

Pain palliation –Skeletal metastases from prostate cancer

Skeletal metastases from prostate cancer

Registration

RV-1:Liposomal delivery

OC-3: Microparticledelivery

TH-1: Receptor targeted delivery

AlpharadinTM

AlpharadinTM

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Commercial strategy

• Algeta has retained all rights to all programs

• AlpharadinTM

– Initiate Phase III program in 2008 – Maximise shareholder value through licensing agreements while

retaining sales and marketing rights in selected territories

• Retain manufacturing rights to maximise margins/control

• OC-3: advance to proof-of-principle in man prior to negotiating partnering deals in selected territories

• TH-1/RV-1: explore early partnership opportunities– TH-1: broad therapeutic antibody enhancement platform, enabling

corporate partnerships in multiple oncology fields– RV-1: potential for therapeutic partnerships with experts in liposomal

product formulation

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Skeletal metastases

• Bisphosphonates used to reduce skeletal complications, no anti-cancer effect

–Delay of skeletal related events including pain, fractures, paralyses

– Approximately 650,000 patients treated yearly1

• Zometa (Novartis) market leader– Sales of $1.3 billion (2006) per year with approximately 70%1 of the market

Current treatment of Hormone Refractory Prostate Cancer (HRPC)

• Chemotherapy widely used• Taxotere (Sanofi Aventis) only drug to show survival benefit – 10 weeks (15 % improvement)

– Sales of $2.3 billion (2006) per year across all cancers – Prostate cancer sales of ~ $630 million per year with 33% market share on a per patient basis

– Price per patient2 ~ $20,000

Alpharadin – Target market overview

1) 2004

2) UK

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• First-in-class product targeting unmet medical need in skeletal metastases– Based on alpha emitter Radium-223– First indication in hormone refractory prostate cancer

(HRPC)– Applicable to advanced breast cancer and other cancers

with bone involvement

• Convenient, ready to use formulation

• Safe and easy to produce, deliver and handle

• The randomised, double-blind, placebo controlled Alpharadin Phase II study showed statistically significant effects, including positive survival data

AlpharadinTM

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AlpharadinTM results published in Lancet Oncology

AlpharadinTM BC1-02 phase II trial

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Alpharadin - Phase II study design (BC1-02)

RANDOMIZE

HRPC patients

Local EBRT

50 kBq/kg b.w. Ra-223 q4 wks

Saline q4 wks

n = 64

W12 M12Study

unblinded

M24

Treatment

4 injectionsq 4 weeks

W16 M 9 M 18

Bone markers, PSA

M 6

Skeletal Related Events (SRE), pain, bone markers, PSA,

safety, survival

Follow-up of long term

toxicity, and survival

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Alpharadin1 Placebo1 P-value

Bone ALP(bone formation marker)

-66% +9% <0.0001

Total ALP(bone formation marker)

-46% +31% <0.0001

PINP(bone formation marker)

-63% +38% <0.0001

CTX-1(bone resorption marker)

-31% +32% 0.002

ICPT(bone resorption marker)

+15% +43% 0.011

PSA(prostate tumour growth)

-24% +45% 0.003

Relative change from baseline to 4 weeks after last injection

All reductions lasted >6 months <9 months after start of treatment, except PSA that lasted > 4 months but <6 months

1 Data presented are median values, ITT population

Positive effect on biomarkers (BC1-02)

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Alpharadin™ – improved survival (ITT)

Maximum

treatm

ent

duration

• Improved overall survival from 46.4 to 65.3 weeks (41% increase)• At 24 months, 10/33 (30%) patients were alive in Alpharadin armversus 4/31 (13%) in placebo arm

• Patients on Alpharadin had 53% reduced risk of death compared withplacebo at each individual time point

• In per protocol population (2 or more injections), the median survivalwas 71.0 weeks (53% increase)

Pro

ba

bilit

y o

f s

urv

iva

l

HR 2.103, p= 0.017

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Alpharadin™ compares favourably to Taxotere

1) Tannock et al., NEJM 351(15):1502-12, 2004. Patients were treated with 75 mg/m2 docetaxelor 12 mg/m2 mitoxantrone (comparator) 10*q3 week. All patients were given 5 mg prednisone twice daily. Mitoxantrone has only shown effect on pain vs placebo, and no survival benefit.

2) Data on symptomatic patients: Berthold et al., ASCO Prostate Cancer Symposium, 2007

AlpharadinTM appears to compare favourably with docetaxel on basis of historical data

41 %46 weeks65 weeks64(ITT population)

Alpharadin study BC1-02

53%46 weeks71 weeks58(PP population)

Alpharadin study BC1-02

Taxotere study1,2

(TAX 327)Symptomatic pats.

Study

16%56 weeks65 weeks305

Median survival

Improvement (%)

ComparatorTaxotere or Alpharadin

Patients treated

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Safety overview (BC1-02)

Adverse events reported in association to the treatment period (up to week 16).

Alpharadin (n=33) Placebo (n=31)

Number of adverse events

155 174

Number of patients with at least one adverse event

31 30

Number of SAEs1 12 19

Number of patients with at least one SAE

8 14

1) Serious Adverse Events

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Moving into Phase III and beyond

•Discussions with European medicines agencies on the Phase III program ongoing

•Discussions ongoing with the Food and Drug Administration (FDA) with a view to opening an IND1

for starting clinical trials in the US

•Ongoing dialogue with key opinion leaders in oncology and nuclear medicine relating to trial design

•Draft design include:– Double-blind, randomized trial– Treatment: 50 kBq/kg Alpharadin given monthly for 6

months– Pivotal endpoints: Progression Free Survival and or Overall

survival

1) Investigational New Drug

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Algeta’s product pipeline

Algeta’s product pipeline comprises different technologies to deliver alpha particle emitters to treat cancer

Skeletal metastases from breast cancer

AlpharadinTM

Development phaseIndicationProduct pipeline

Research Preclinical

Phase I

Clinical development

Phase II Phase III

Soft tissue tumours

Intracavitary cancer

Various cancer indications

Pain palliation –Skeletal metastases from prostate cancer

Skeletal metastases from prostate cancer

Registration

RV-1:Liposomal delivery

OC-3: Microparticledelivery

TH-1: Receptor targeted delivery

AlpharadinTM

AlpharadinTM

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TH-1: Receptor targeted delivery

• Potential to target a range of different cancer types

• Algeta has demonstrated the therapeutic enhancement of a marketed monoclonal antibody (mAb) in oncology

• Rituxan® - in animal models, recently published in Blood. Rituxan 2006 US sales of USD 2 bln.

• Further studies with another antibody ongoing in collaboration with the Norwegian Radium Hospital

• Algeta initiated anticancer targeted therapy collaboration with Affibody in 2006 and an undisclosed partner in June 2007

• Future milestones:– Partner discussions with mAb companies

– Selection of development candidates

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• Targeting intracavitary cancers

• First application addressing ovarian cancer– Large medical unmet need for effective treatments – Disseminated tumour within the abdominal cavity

• Microparticulate product– Proprietary methods for binding and retention of radionuclides– Distributed within peritoneal cavity to irradiate disseminated

ovarian tumours– Encouraging results in animal model systems

• Future milestones– Selection of development candidate– Preclinical toxicity studies– Clinical trials

30,44649,297Japan, China, India

41,02463,467Europe

16,00525,162Northern America

124,860204,499World

MortalityIncidenceOvarian cancer

OC-3: Microparticle delivery

Source: Globocan 2002

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• Focus on treatment of soft tissue tumour

• Preclinical tumour-targeting studies ongoing– Extended biological half-life in blood – Targeting soft tissue tumours. Delivery to tumour via vascular

leakage– Demonstrated uptake of radium-223 in non-skeletal metastases

• Evaluating radio- and chemotherapy combinations

• Future milestones:– Conclusion of preclinical studies– Partnering discussions with experts in liposomal product

formulation

223Ra

RV-1: Liposomal delivery

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Solid intellectual property position

• Leading position in alpha particle emitter technology

• Broad patent estate of circa 140 filed patent applications of which 79 are issued within the following patent families:

Status in major countries

– BC-1 Alpharadin Granted EU & US– OC-3 Microparticulates Filed EU & US– RV-1 Radioactive liposomes Granted EU & US– RV-2 Radiochemo liposomes Filed EU & US– TH-1 Method of radioimmunotherapy Filed EU & US– BC-2 Bone seeking conjugates Granted EU & US– BC-1-1 Combination with phosphonates Filed US– OC-1 Receptor binding conjugates Granted US, filed EU

Granted patents expires 2019-2024.

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Experienced management and board of directors

Management Team

Board of DirectorsJohn Berriman Chairman, formerly Abingworth and Celltech, UK

Stein H. Annexstad Managing Director, Holstein AS, Asker, formerly CEO of Nycomed

Jens Petter Falck Partner, Incitia Ventures, Oslo

Kent Gossett General Partner, SR One, West Conshohocken

Patrick Lee General Partner, Advent Venture Partners, London

Inga Loen M.D., Ullevål University Hospital, Oslo

Per Samuelsson Partner, HealthCap, Stockholm

Thomas Ramdahl President and CEO, formerly Pharma Division Norsk Hydro

Peter Harris CMO, formerly Oxigene Inc, KuDos Pharma, Amgen, Roche

John Michael Dornish CSO, formerly FMC Biopolymer and Pronova Biomedical

Roger Harrison CBO, formerly BTG plc and Amersham

Geir Christian Melen CFO, formerly PhotoCure

Ragnhild M. Løberg VP Quality and Regulatory Affairs, formerly Pronova Biocare

Kari Dyvik VP Operations, formerly PhotoCure and Nycomed Amersham

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Algeta ASA has a total of 696,500 share options outstanding (vested and unvested).

HealthCap related companies 2,640,000 16.0 %

Advent Venture partners related companies 1,880,000 11.4 %

Selvaag Venture Capital AS 1,366,140 8.3 %

S.R. One Ltd 1,158,200 7.0 %

Morgan Stanley & Co Inc (nominee) 1,039,400 6.3 %

NorgesInvestor III AS 986,280 6.0 %

Bank of New York, Brussels Brance (nominee) 455,080 2.8 %

Tredje AP-Fonden 427,400 2.6 %

Roy H. Larsen 426,840 2.6 %

Deutsche Bank AG London (nominee) 391,449 2.4 %

Bear Stearns Securities Corp. (nominee) 357,720 2.2 %

Skandinaviska Enskilda Banken (nominee) 347,400 2.1 %

Nordea Bank Sweden AB (PUBL) (nominee) 346,984 2.1 %

JPMBLSA (nominee) 288,370 1.7 %

JPMorgan Securities Ltd 256,700 1.6 %

Other 4,138,645 25.1 %

Total 16,506,608 100.0 %

FinancialsOperating costs developing according to plan

• NOK 38.6 NOK million (USD 7.0 million) in operating costsin the first 6 months of 2007

Strong financial Position• Total liquid funds of NOK 316 million (USD 57.5 million) as

of June 30 2007

List of shareholders as of 8 August 2007

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Expected news flow

Further collaborations/partnerships

Initiation of phase II trials on breast cancer

Patient enrolment phase III trials on prostate cancer

Data for BC1-05

4 month follow-up data for BC1-04

4 month follow-up data for BC1-03

Further collaborations /partnerships

US IND application/approval

Further pre-clinical data

Patient enrolment ends for BC1-05

Patient enrolment ends for BC1-04

Patient enrolment ends for BC1-03

Peer review publication for BC1-02

Patient enrolment begins for BC1-05

ASCO presentation 18 month follow up data for BC1-02

First results Affibody feasibility collaboration

Activity

TH-1

Alpharadin

Alpharadin

Alpharadin

Alpharadin

Alpharadin

TH-1

Alpharadin

OC-3

Alpharadin

Alpharadin

Alpharadin

Alpharadin

Alpharadin

Alpharadin

TH-1

Project

2008

Status / commentsTiming

H2 2007

2nd feasibility collaboration entered into in H1 2007

H2 2007

2008

H1 2008

H1 2008

2008

H1 2008

H2 2007

H2 2007

H2 2007

H2 2007

H2 2007

H1 2007

H1 2007

H1 2007

Published in Lancet Oncology in June

Started in June 2007

Presented in June 2007

First results obtained, further testing ongoing

Page 25: Corporate Presentation October 2007kundeweb.aggressive.no/users/algeta.no... · Cancer is a major disease Algeta’s lead program targets skeletal metastases from prostate cancer,one

Algeta ASA

Kjelsåsveien 172 APO BOX 54 Kjelsås

NO 0411Oslo

Norway

Tel: +47 23 00 79 90

www.algeta.com