corporate presentation october 2007kundeweb.aggressive.no/users/algeta.no... · cancer is a major...
TRANSCRIPT
Algeta ASA
Company Presentation
October 2007
2
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
3
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
4
Cancer treatment options
ChemotherapySurgery Radiotherapy
Traditional:
Algeta’s technology:
Targeted internal radiotherapy
5
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
6
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
7
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
8
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
9
• 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
10
AlpharadinTM results published in Lancet Oncology
AlpharadinTM BC1-02 phase II trial
11
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
12
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)
13
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
14
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
15
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
16
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
17
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
18
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
19
• 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
20
• 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
21
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.
22
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
23
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
24
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
Algeta ASA
Kjelsåsveien 172 APO BOX 54 Kjelsås
NO 0411Oslo
Norway
Tel: +47 23 00 79 90
www.algeta.com