Algeta ASA
- Andrew Kay, President & CEO
Jefferies 2010 Global Life Sciences Conference
2010 V10
Algeta ASA - - PowerPoint PPT Presentation
Algeta ASA Andrew Kay, President & CEO Jefferies 2010 Global Life
Jefferies 2010 Global Life Sciences Conference
2010 V10
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THIS PRESENTATION AND ITS ENCLOSURES AND APPENDICES (HEREINAFTER JOINTLY REFERRED TO AS THE “PRESENTATION” HAS BEEN PREPARED BY ALGETA ASA (THE “COMPANY”) EXCLUSIVELY FOR INFORMATION PURPOSES. THIS PRESENTATION HAS NOT BEEN REVIEWED OR REGISTERED WITH ANY PUBLIC AUTHORITY OR STOCK EXCHANGE. RECIPIENTS OF THIS PRESENTATION MAY NOT REPRODUCE, REDISTRIBUTE OR PASS ON, IN WHOLE OR IN PART, THE PRESENTATION TO ANY OTHER PERSON.THE CONTENTS OF THIS PRESENTATION ARE NOT TO BE CONSTRUED AS LEGAL, BUSINESS, INVESTMENT OR TAX ADVICE. EACH RECIPIENT SHOULD CONSULT WITH ITS OWN LEGAL, BUSINESS, INVESTMENT AND TAX ADVISER AS TO LEGAL, BUSINESS, INVESTMENT AND TAX ADVICE.THERE MAY HAVE BEEN CHANGES IN MATTERS THAT AFFECT THE COMPANY SUBSEQUENT TO THE DATE OF THIS PRESENTATION. NEITHER THE ISSUE NOR DELIVERY OF THIS PRESENTATION SHALL UNDER ANY CIRCUMSTANCE CREATE ANY IMPLICATION THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF OR THAT THE AFFAIRS OF THE COMPANY HAVE NOT SINCE CHANGED, AND THE COMPANY DOES NOT INTEND, AND DOES NOT ASSUME ANY OBLIGATION, TO UPDATE OR CORRECT ANY INFORMATION INCLUDED IN THIS PRESENTATION.THIS PRESENTATION INCLUDES AND IS BASED ON, AMONG OTHER THINGS, FORWARD6LOOKING INFORMATION AND STATEMENTS. SUCH FORWARD6LOOKING INFORMATION AND STATEMENTS ARE BASED ON THE CURRENT EXPECTATIONS, ESTIMATES AND PROJECTIONS OF THE COMPANY OR ASSUMPTIONS BASED ON INFORMATION AVAILABLE TO THE COMPANY. SUCH FORWARD6LOOKING INFORMATION AND STATEMENTS REFLECT CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS, UNCERTAINTIES AND ASSUMPTIONS. THE COMPANY CANNOT GIVE ANY ASSURANCE AS TO THE CORRECTNESS OF SUCH INFORMATION AND STATEMENTS. AN INVESTMENT IN THE COMPANY INVOLVES RISK, AND SEVERAL FACTORS COULD CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS THAT MAY BE EXPRESSED OR IMPLIED BY STATEMENTS AND INFORMATION IN THIS PRESENTATION, INCLUDING, AMONG OTHERS, RISKS OR UNCERTAINTIES ASSOCIATED WITH THE COMPANY’S BUSINESS, SEGMENTS, DEVELOPMENT, GROWTH MANAGEMENT, FINANCING, MARKET ACCEPTANCE AND RELATIONS WITH CUSTOMERS, AND, MORE GENERALLY, GENERAL ECONOMIC AND BUSINESS CONDITIONS, CHANGES IN DOMESTIC AND FOREIGN LAWS AND REGULATIONS, TAXES, CHANGES IN COMPETITION AND PRICING ENVIRONMENTS, FLUCTUATIONS IN CURRENCY EXCHANGE RATES AND INTEREST RATES AND OTHER FACTORS. SHOULD ONE OR MORE OF THESE RISKS OR UNCERTAINTIES MATERIALISE, OR SHOULD UNDERLYING ASSUMPTIONS PROVE INCORRECT, ACTUAL RESULTS MAY VARY MATERIALLY FROM THOSE DESCRIBED IN THIS DOCUMENT. THE COMPANY DOES NOT INTEND, AND DOES NOT ASSUME ANY OBLIGATION, TO UPDATE OR CORRECT THE INFORMATION INCLUDED IN THIS PRESENTATION. This Presentation does not constitute an offer or invitation for the sale or purchase of securities or assets in any jurisdiction, and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. The shares have not been registered under the Securities Act of 1933, as amended (the “Act"), or any applicable U.S. state securities laws, and may not be offered, sold or otherwise transferred, pledged or hypothecated unless (i) pursuant to registration under the act or (ii) in compliance with an exemption therefrom.
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6 Promise of Alpha6Pharmaceuticals 6 Unique alpha emitting proprietary technology 6 Strong IP position
6 USD 41m IPO
6 ALSYMPCA pivotal global trial
6 Cash USD 84m (end 1Q10)
,--. /%%. /%%$ /%%- /%,%
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– Potent and localized cancer cell killing activity
– An area of high medical need and significant commercial potential – Phase II data: Overall survival, QoL and highly tolerable side6effect profile
– Major partnership; Phase III recruitment on schedule, trial expansion
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– Impressive Overall Survival in CRPC phase II (>40% increase p=0.017) – Enhanced Quality of Life – Highly tolerable side6effect profile – Ideal addition to cancer treatment regimes – Controls pain – Easy to use 6 out6patient procedure
(0
Sources: US market research commissioned from Decision Resources (May 2008) EU market research commissioned from Bridgehead (May 2008)
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up to 90% of certain late6stage cancers
− E.g. prostate, breast, lung
no effective treatment
impair patient QoL and further reduce life expectancy "Bone metastases are associated with significant pain, neurological symptoms, pathological bone fractures, hypercalcaemia, and pancytopenia ultimately leading to death12
Ref: Mundy GR. Metastasis to bone: Nat Rev Cancer. 2002;2:5846593
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Incidence in US Incidence in EU, top 5 &(343 5" *-67%%%
SEER for US and Ferlay et al (Annals of Oncology. 2007) for EU. Incidence data for breast and lung cancers in EU are derived from ‘top 5’ incidence data contained in Datamonitor Stakeholder Opinion report published March 2008. Global Cancer Facts & Figures 2007, American Cancer Society
8 */+97%%%
8 *.$/7%%% ;+$67%%% <
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BONE METASTASES Alpharadin
Prostate (CRPC) Breast (Endocrine refractory)
“It is estimated that more than 1.5 million cancer patients worldwide have bone metastases.”
!"#$%& "'(()"*+() ,*- ---.*
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– Naturally targets new bone growth in and around bone metastases
Alpharadin is a new class alpha6pharmaceutical
=! >
& =
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4//?
– Short penetration of alpha emitters (2610 cell diameters) means highly localized tumor cell killing & minimal damage to surrounding normal tissue
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Alpharadin group; 4.5 months difference
versus 13% (4 pts) in the placebo group
! Patients with Bone metastases in CRPC 6 BC1602 trial
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Alpharadin (n=33) Placebo (n=30) Grade 1 2 3 4 1 2 3 4 Platelets 6 4 1 Neutrophils 5 2 1 WBC 9 1 1 3 Hemoglobin 26 4 1 19 6 1 Worst grade for hematological toxic effects during treatment in BC1602*
* Data are numbers of patients
(>=
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Alpharadin (n=33) Placebo (n=31)
Mild Mod. Severe Total Mild Mod. Severe Total Diarrhea 6 3
5 ,% Constipation 6 5 1 ,/ 2 / Vomiting 4 4 $ 3 3 6 Nausea 6 3
3 1 ,% Fatigue 3 5 $ 7 . Bone pain 2 7 1 ,% 7 7 2 ,6 Myalgia 3 2 + 3 1 9 Tumor flare 2 3 1 6 1 5 1 . Anemia 5 + 2 3 2 .
Table lists adverse events in more than 15% of the BC1602 study population during treatment
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Nausea 97 (33%) 10 (32%) Bone Pain 89 (30%) 16 (52%) Diarrhoea 77 (26%) 10 (32%) Fatigue 76 (26%) 7 (23%) Anaemia 71 (24%) 7 (23%) Constipation 60 (21%) 2 (7%) Vomiting 59 (20%) 6 (19%) Adverse events from 292 patients in Phase I and II trials :;@< ;/-/<!;?,<
(AEs seen in > 15 % patients in all clinical studies receiving Alpharadin in any dose), compared with adverse events from patients in the placebo group in BC1602 (31 pts)
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– Patients with symptomatic CRPC and ! for whom no cytotoxic drug treatment is planned – ~ 75% of the total CRPC market – Alpharadin plus best standard of care – Placebo plus best standard of care –
A total of 900 patients – Randomization 2:1 in favor of Alpharadin – Recruitment on track for full enrollment by 2H 2010
' '
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– Over 125 centers worldwide recruiting prostate cancer patients with bone metastases – Recruitment reached 650 patients May 2010
– PI 6 Dr Oliver Sartor; Internationally recognised cancer expert; Piltz Professor of Cancer Research, Tulane Cancer Center, New Orleans – 4 centers recruiting, 7 initiating , 15 in total planned
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125 250 375 500 625 750 Jun'08 Dec'08 Jun'09 Dec'09 May'10
:! ;<
Enrollment of 900 patients is anticipated on schedule during the second half of 2010
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!
– World experts in Europe leading this trial; Prof Robert Coleman PI – First patient January 2010
– Trial planned in the USA with leading centres – First patient during 2010
~ 75% breast patients with metastatic disease have bone metastases
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Notes: 6 Upfronts, milestones and royalties under the agreement is in EUR. In this presentation, EUR = 1.43 USD 6 “Bayer” is used for Bayer HealthCare throughout this presentation
4 " ( 3 4' Algeta can retain 50% of the US market
USD 61m (EUR42.5m) signature fee USD 800m (EUR560m)
Bayer to contribute substantial majority of costs for Alpharadin clinical development program for bone metastases in advanced prostate and other cancer indications Tiered, double digit
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– CRPC patients and expansion into other cancer indications
6 Full US subsidiary at launch 6 Field force, medical liaison, marketing
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Specific binding of mAb to cancer cells Monoclonal antibody (mAb) Thorium-227 Alpha particles from Thorium-227 kill tumor cells with specific binding due to the short radiation range 50-100 µm long, high energy ionizing alpha track Alpha particle (helium nucleus)
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Thorium6227 – excellent profile for conjugation
Conjugation chemistry crucial
Targeting molecules
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Alpha 6 Hitting adjacent cells / /*#0*#-- There are not targets on all tumor cells due to cell heterogeneity
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payloads 1 -
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3 ! ( USD 84m at Q1 2010
– Bayer cost6sharing on Alpharadin development
– Establishing US commercial operations – Market preparation and launch
An additional MUSD 160 due in potential milestones from Bayer between now and launch
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2009
Initiate breast ph II
2010 2011 2012
Breast ph II bone markers results Initiate combination ph I/II with docetaxel in prostate Combination ph II results ALSYMPCA: First US patient ALSYMPCA: Sample size Re-estimation/ confirmation ALSYMPCA: complete recruitment ALSYMPCA results
(event driven)
Commercial manufacturing contract Manufacturing expansion commences Initiate programs: Use
tumor-targeting molecules $800m Bayer deal for Alpharadin $37m equity raise EOPII FDA Alpharadin filing
= half year
Combination ph II safety results
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financial position to underpin Alpharadin
:
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Andrew Kay, CEO +47 2300 7990 / +47 4840 1360 Øystein Soug, CFO +47 2300 7990 / +47 9065 6525 post@algeta.com 2 3 +44 207 638 9571 Mark Swallow/Helena Galilee/ mark.swallow@citigatedr.co.uk David Dible Citigate Dewe Rogerson 4&. 2 3 +1 646 378 2928 Jessica Lloyd jlloyd@troutgroup.com The Trout Group
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