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Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Presentation on theme: "Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President."— Presentation transcript:

1 Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President

2 2 Basic facts Listed since 1996 (OME: MVIRB SS) MCap: ~ USD 180m Major shareholders: Staffan Rasjö Founders Handelsbanken Den Norske Bank Skandia Cash position: SEK 370m (end-Q1) Revenues: SEK 129m (FY 2006) Burn rate: SEK 155m (FY 2006) 18 month performance

3 3 The strategic journey 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 4 Pipelines and partners

5 5 OSTEOPOROSIS HEPATITIS C LABIAL HERPES Key projects Lipsovir ®, Phase III data late 2007. Market approval by end of 2008. 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 6 Labial herpes (Lipsovir ® ) 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 7 Herpes virus Immune defense

8 8 Herpes virus Immune defense Current drugs

9 9 Herpes virus Immune defense Lipsovir ®

10 10 TreatmentPrevention of cold sores Reduction in lesion healing time Topical vs placebo Acyclovir Penciclovir Docosanol (Abreva) No 10 - 12% 13 - 15% (15%) Oral vs placebo Acyclovir Valaciclovir No 9 - 13% 10 – 11% Lipsovir ® vs placeboYes, 29%11% (19%*) * Episode duration Lipsovir ® : first to show prevention

11 11 A billion dollar market Annual value growth: 12% Annual value growth: 9% OTC (USD 220m) Rx (USD 450m) Palliative (USD 400m)

12 12 Development process July 06Jan 07Mar 07H2 07H1 08end-082009 Start Phase III 75% treated 60% treated Phase III data Filing Approval Genital Herpes? Marketing Partner(s)

13 13 Three of four sufferers express an interest in Lipsovir ® Definitely would buy Probably would buy Might or might not buy Probably would not buy Definitely would not buy Primary market research 403 (UK) 411 (US) respondents

14 14 Physician prescribing habits post- launch of 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)

15 15 Hepatitis C – HCV PI Market 170-200 million infected Over 50% non-responders to current treatments 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

16 16 Medivir/Tibotec HCV PI Series Several series of highly promising NS3/4A inhibitors have been developed Further optimization of these inhibitors in collaboration with Tibotec Pharmaceuticals Ltd, J&J, has resulted in the selection of a Clinical Candidate Enzymatic activity on genotype 1b (Ki, nM) <1nM Replicon activity on genotype 1b [IC 50, nM] <10nM In vivo PK, Oral dose: 10 mg/kg Cmax (µM) T 1/2 (h) F (%) 0.95 5.4 20 Data on Compound “A” (an example from the lead series) From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006 and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden

17 17 Bone disorders (MIV-701) 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

18 18 Bone disorders (MIV-701) 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)

19 19 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

20 20 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

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


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