Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR.

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Presentation transcript:

Medivir AB Aktiespararna i Norrköping 18 April 2007 Rein Piir, CFO / IR

– Delivery according to Strategy Progress protease projects Secure Lipsovir approval in 2008 Finding new harbours for polymerase projects Outlicensing of HIV PI Prolonged agreement on HCV PI Q2 Q3 Q4 Q1 Outlicensing of MIV-210 Lipsovir enters Phase III Outlicensing of MIV-606 Outlicensing of MIV-170 HCV PI: Tibotec files CTA Milestone (EUR 2.5m) Outlicensing of MIV-310 Outlicensing of MIV-410 Enrollment update: 60% of patients treated in pivotal trial Outlicensing of MIV 160 MIV-606: Shares in Epiphany and milestone (USD 0.5m) HCV PI: Start of phase I Milestone (EUR 2.5m) MIV-701: Start of phase I

3 Next phase in Medivir transformation - A focused pharmaceutical company Successful outlicensing of 6 polymerase projects. Strong partnerships with deal value in excess of 400 MUSD plus royalties Nordic marketing rights for all projects and possible product from J&J

4 Medivir: pipelines and partners

5 OSTEOPOROSIS HEPATITIS C LABIAL HERPES Key Projects Lipsovir®, Phase III studies completed late Market approval by end of Collaboration with Tibotec / Johnson & Johnson. Phase I trials ongoing. MIV-701, Phase I trials ongoing. Further indications such as OA, RA and bone metastases explored.

6 Labial Herpes (Lipsovir®, ME-609) First drug to treat and prevent cold sores Low-risk — based on safe, well-documented and already marketed compounds Goal: Marketing permission from regulatory authorities by 2008

7 HSV-1 Immune response Dual mechanism of action

8 HSV-1 Immune response Current drugs Dual mechanism of action

9 HSV-1 Immune response Lipsovir ® Dual mechanism of action

10 TreatmentPrevention of cold sores Reduction in lesion healing time Topical vs placebo Acyclovir Penciclovir Docosanol (Abreva) No % % (15%) Oral vs placebo Acyclovir Valaciclovir No % 10 – 11% Lipsovir ® vs placeboYes, 29%11% (19%*) * Episode duration Lipsovir ® : first product to show prevention

11 Labial Herpes (Lipsovir®) Market Global market $666M; split 33% OTC, 67% Rx Additional $400M palliative OTC market (estimate) Strong annual growth: OTC +$11.6% and Rx +$9% Cold sore treatments second fastest growing OTC category Process Phase III ahead of schedule, more than 60% of patients treated by January 2006 Data from pivotal trial during autumn 2007 Estimated approval by end of 2008 Potential upside in genital herpes Patent/generic competition Patents protect Lipsovir from generic competition until Uncommonly difficult and time-consuming for competitors to register a copy of a topical drug as all clinical trials must be repeated Partner strategy Finalize phase III on our own - partnerships for market launches

12 Lipsovir ® consumer interest Definitely would buy Probably would buy Might or might not buy Probably would not buy Definitely would not buy Strong interest in the concept: 1 in 4 in the UK and 1 in 3 in the USA claim they ‘would definitely buy’ Around three quarters of sufferers express an interest in Lipsovir ® Primary market research 403 (UK) 411 (US) respondents

13 Physician prescribing habits post Lipsovir ® Primary market research Base: 225 physicians who have prescribed cold sore remedies 10+ times in the last 12 months Physicians are willing to prescribe a new cold sore remedy When asked what they would prescribe on the next 10 occasions, Lipsovir claims a 45% share of prescriptions, making it the leading product and drawing users from all 3 principal Rx brands (Zovirax, Valtrex, Denavir)

14 Hepatitis C - HCV PI Market million infected globally Over 50% non-responders to current treatments, growing medical need Estimated market value in 2010: 7.8 billion USD Process Partnership with Tibotec / Johnson & Johnson since November 2004 Candidate drug selected 2005 CTA submitted December 2006 Phase I trials started February 2007 Patents Extensive and non-limiting IP published July 2005 Key enzyme for virus replication Enzyme inhibiting compound

15 MIV-701 (Bone Disorders) MIV-701 selectively inhibits the bone and cartilage degrading enzyme cathepsin K Osteoporosis, osteoarthritis and bone metastases Target profile: Improved bone quality (c/f bisphosphonates) Bone growth capability Once-daily oral dosing Strong Back-up program in place with pre-CD’s selected Bone surface Osteoclast Cath K

16 MIV-701 (Bone Disorders) Market Approx 100 million patients in major growing markets (osteoporosis only) Global osteoporosis market 11 billion USD by 2008 Strong interest in cathepsin K inhibition from major pharma companies Process Clinical phase Ia trials commenced March 2007 Phase Ib trials planned for late 2007 Patent/generic competition Patent applications being processed Expected patent protection until 2025 Partner strategy Establish industrial partnership after completion of phase Ib (2008)

17 HIV – PI –Collaboration project with Tibotec / Johnson & Johnson MMP- COPD –Collaboration with Hengrui –Extensive IP, excellent results in pre-clinical disease model –Next step: selection of Candidate Drug Renin - Hypertension –IP compiled for three distinct and potent inhibitor series –Next step: studies in a pre-clinical efficacy model Cathepsin S – RA, MS and pain –Potent and selective inhibitors –Efficacious in preclinical disease models –Fine-tuning of PK properties Several early protease programs, e.g. Alzheimer's (BACE inhibitors) and novel cholesterol lowering MOA Large inhibitor libraries and proprietary technologies –facilitate CD generation against any new protease target “The Protease Discovery Engine” – A reliable repeat innovator

18 MIV-701 HEPATITIS C LIPSOVIR The journey ahead Phase III data, autumn 2007 Partnership agreement(s) Market registration, end-2008 Phase I data during 2007 Possibility to receive “approved drug” from Johnson & Johnson Phase I data during 2007 Partnership post phase I HIV FRANCHISE MIV-170: Entry into phase I by late 2007 MIV-606 start of phase IIb trials New clinical trials and new data in other out- licensed projects

LIPSOVIR ® A profitable pharmaceutical company with its own research and sales Next step in company transformation