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Company Presentation Summer 2004

Company Presentation Summer 2004. Medivir in brief. One of the world leaders in polymerase research. Aiming for a similar position in protease research. Unique competitive advantages in all clinical projects. Nine partnerships with eight companies and a broad

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Company Presentation Summer 2004

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  1. Company Presentation Summer 2004

  2. Medivir in brief • One of the world leaders in polymerase research. • Aiming for a similar position in protease research. • Unique competitive advantagesin all clinical projects. • Nine partnerships with eight companies and a broad • network with academia in Europe and US. • Total deal value amounting to > SEK 2000m • Nordic marketing rights for all projects. • Located in Stockholm (Sweden) and Cambridge (UK) with • approximately 100 employees in R&D.

  3. Skilled and experienced management Anders Vedin – M.D., Professor – Chairman of the Board Previous positions include President of Astra Hässle Lars Adlersson – B.Sc. (Business Adm & Econ) – CEO Previous positions include Vice President and General Manager GlaxoSmithKline Austria, Managing Director GlaxoWellcome Sweden. Johan Harmenberg M.D. Associate Professor – VP Drug Development Previous positions include Clinical Research Director, Medical Advisor and Medical Director at Roche, Astra and Pharmacia & Upjohn. Bertil Samuelsson – Ph.D. Professor – VP Research Previous positions include Head of Medical Chemistry at AstraZeneca. Rein Piir – B.Sc. (Business Adm & Finance) – CFO / IR Previous positions include Head of Research and Health Care at Carnegie Investment Banking, Health Care and Strategy at Alecta Asset Management Paul Wallace - Ph.D. – VP Business Development Previous positions include Business Development Manager at Peptide Therapeutics and Director of Research at Eclagen.

  4. Medivir pipeline and market

  5. Medivir’s clinical and pre-clinical projects Discovery Lead Optimisation Late preclinical IND Phase I Phase II Phase III NDA Market identification phase development RP-606 Shingles ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV MIV-210 NRTI Multi-resistant HIV MIV-150 NNRTI HIV Population Council MV026048 Cath S Cath K MIV-170 HCV Polymerase inhibitor HCV Combination including polymerase inhibitor Alzheimer Protease inhibitor COPD Polymerase and protease inhibitors New proteases Other activities

  6. Unique Selling Propositions in all clinical projects • Valomaciclovir (RP 606) – shingles • Expected to reduce chronic pain • ME 609 – labial herpes Expected to prevent ulcerative lesions • Alovudine (MIV 310) - HIV-NRTI • Excellent activity against multi-resistant strains • Once daily dosing • MIV 210 – HIV-NRTI • Excellent activity against multi-resistant strains • High oral bioavailability

  7. Valomaciclovir (RP 606) Indication: Shingles Competitive advantage: Expected to reduce chronic pain IP protection: Patents to 2017 Partner: Reliant (1.000 sales reps in US) Status: Phase II completed Ongoing preparations for Phase III valomaciclovir expected to reduce chronic pain

  8. The chronic pain (PHN), is the major problem for shingles patients Share of patients Acute phase Chronic pain time valomaciclovir expected to reduce chronic pain

  9. ME 609 Indication: Labial and genital herpes Competitive advantages: First drug to prevent labial lesions IP protection: Patents to 2016 in US and EU Partner: No Status: Positive phase II data Preparation prior to phase III ongoing ME 609 avoid your next cold sore

  10. You can avoid your next cold sore No treatment 0% Existing drugs 0% ME 609 29% Avoided outbreaks 0% 5% 10% 15% 20% 25% 30% ME 609 avoid your next cold sore

  11. Alovudine (MIV 310) Indication: HIV Competitive advantages: No resistance development observed in phaseIIa, or in vitro. Unique multi-resistance profile. Once daily oral dosing Exceptionally low COGS IP protection: Patents to 2019 (USA) Partner: Boehringer Ingelheim Status: Phase IIa data showed unique activity against multi-drug resistant HIV Licensed to Boehringer Ingelheimin July 2003 BI recently started phase II dose range studies

  12. MIV 210 Indication: HIV, Hepatitis B Competitive advantages: Unique multi-resistance profile, different from MIV-310 Excellent oral bioavailability in humans Low COGS Next generations NRTI in fixed-dose-combination* IP protection: Patents to 2018 Partner: GlaxoSmithKline Status: Licensed to GSK in May 2003 Broad range of preparations prior to phase II ongoing NDA expected to be filed in H2 2007 * Expected peak sales: USD 500 – 1.000m * * Information from GSK’s R&D-day

  13. High Market Potential* Even without any drug preventing labial herpes, sales amounted to more than USD 500m in 2003 Sales of shingles drugs > USD 1.000m in 2003. None of the existing drugs have a claim for PHN RP-606 Shingles ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV MIV-210 NRTI Multi-resistant HIV MIV-150 NNRTI HIV Sales of HIV drugs amounted to USD 5.800m in 2003. NRTI’s represented 60% and are expected to grow their market share above 70% in the coming five years Population Council MV026048 MIV-170 Growing share of multi-resistant HIV. MIV-310 and 210 are developed to address this Cath S Cath K HCV HCV Alzheimer COPD * Market data according to IMS-data

  14. HIV market is expected to grow rapidly, NRTI’s having the largest share

  15. The Late Stage Preclinical Pipeline Discovery Lead Optimisation Late preclinical IND Phase I Phase II Phase III NDA Market identification phase development MV026048 A new treatment paradigm for RA, MS and asthma. Possible improvements over TNF-alpha blockers. Cath S Cath K MIV-170 HCV HCV New treatment paradigm for osteoporosis and osteoarthritis. Present therapies like, bisphosphonates and HRT all have limitations COPD Strong presence in hepatitis C Polymerase inhibitor Protease inhibitor

  16. The Cathepsin S Project(JV with Peptimmune) • Potential indications: • Immunological disorders (e.g. rheumatism, multiple sclerosis) • Chronic pain • Competitive advantages: • New class of drugs for treating autoimmune and inflammatory diseases. • Project status: • Potent and selective compounds identified. • Oral administration results in impressive efficacy in pre-clinical disease • models. • EU-patent granted for cathepsin S-inhibitors in immune reactions. • A Candidate Drug was recently selected in the program, and the • project is now in preclinical development towards a IND. • No competing projects identified in clinical development

  17. Osteoporosis and Cathepsin K • Osteoporosis: • The amount of treated patients is expected to grow from • 7.8m (2002) to 18.3m (2015)* • Market size 2001: USD 5.5bn (2001) is expected to grow • to USD 11bn(2008)** • Cathepsin K: • An enzyme involved in the process of bone destruction. • By inhibiting cathepsin K, the bone destruction process is reduced. • This has recently been proved by Novartis in a phase IIa POC study. • No other competing projects identified in clinical development. • *Datamonitor, Epidatabase (2003) • **IMS Data

  18. Medivir’s Cathepsin K Project • Potential indications: • Osteoporosis • Osteoarthritis, Paget’s Disease, Bone metastasis, RA, Bone cancer etc. • Competitive advantages: • A new treatment principle. By regulating cathepsin K the bone breakdown • process will be controlled. This will open up possibilities in a range of diseases. • Project status: • Potent and selective inhibitors of cathepsin K with drug like properties identified. • The inhibitors have shown good effect in an in vitro-model for human bone resorption. • The project is at an advanced stage in i preclinical optimisation. • Strong IP on NCE’s have been filed.

  19. Balancing risk Five individual projects in clinical development RP-606 Shingles ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV MIV-210 NRTI Multi-resistant HIV Total deal value > SEK 2.000m MIV-150 NNRTI HIV Population Council Partners in four clinical projects MV026048 Cath S Cath K Three Joint Ventures Five individualprojects able to generate royalty MIV-170 HCV HCV Four individual projects able to generate milestones Alzheimer COPD New proteases Other activities

  20. The strategic journey

  21. Medivir: the strategic journey Today Tomorrow Pharma • Polymerase inhibitors in clinical development and protease inhibitors in pre-clinical research. • Broad range of partnerships. • Nordic marketing rights to all projects. • Approximately 120 employees. • Research based biotech company. • Polymerase and protease inhibitorsin • clinical development • Broad range of partnerships. • First product launch from own pipeline. • Aim for product swaps in coming • partnerships. • Research based pharmaceutical company • with a sales force focusing on specialist • products for the Nordic region.

  22. A broader clinical portfolio creates higher value Value Osteoporosis Autoimmune disorders 2004 and onwards Infectious diseases Infectious diseases Time

  23. Financial information

  24. Key Financial Data 31th of March 2004 • Result after financial items amounted to SEK -45,3 (-47,1)m. • SEK 208m in cash. • Net R&D costs for 2004 will be approximately SEK 175m, this is in line with previous years. • The Q2 report will be published on the 6th of July.

  25. Pharma World leader in drugs inhibiting proteases and polymerases

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