Company Presentation Summer 2004. Medivir in brief One of the world leaders in polymerase research. Aiming for a similar position in protease research.

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Presentation transcript:

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 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.

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.

Medivir pipeline and market

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

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

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 expected to reduce chronic pain

Acute phase time Share of patients The chronic pain (PHN), is the major problem for shingles patients Chronic pain

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 avoid your next cold sore

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

Alovudine (MIV 310) Indication: HIV Competitive advantages: No resistance development observed in phase IIa, 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 Ingelheim in July 2003 BI recently started phase II dose range studies

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 H * Expected peak sales: USD 500 – 1.000m * * Information from GSK’s R&D-day

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

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

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

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

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

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.

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

The strategic journey

Medivir: the strategic journey 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 inhibitors in 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. Today Tomorrow

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

Financial information

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.

World leader in drugs inhibiting proteases and polymerases