Presentation is loading. Please wait.

Presentation is loading. Please wait.

Medivir September 2007 Lunch presentation at SHB CEO Lars Adlersson VP Research Bertil Samuelsson CFO / IR Rein Piir.

Similar presentations


Presentation on theme: "Medivir September 2007 Lunch presentation at SHB CEO Lars Adlersson VP Research Bertil Samuelsson CFO / IR Rein Piir."— Presentation transcript:

1 Medivir September 2007 Lunch presentation at SHB CEO Lars Adlersson VP Research Bertil Samuelsson CFO / IR Rein Piir

2 2 Business model Research & development of protease inhibitors Sales & marketing of proprietary products Structure:Revenue streams: Upfronts & milestones Royalties Pharmaceutical sales revenues Quids (e.g. JNJ) Own products (e.g. HIV Franchise, HCV PI) Acquired products Co marketing

3 3 OSTEOPOROSIS HEPATITIS C (TMC-435350) LABIAL HERPES Key projects and recent events Lipsovir ®, all patients enrolled in the phase III programme Phase I trials ongoing Pre-clinical data presented on TMC-435350 MIV-701, Phase Ib trial ongoing Sales & marketing VP Sales and Marketing starts in October

4 4 All patients now enrolled in phase III program 4 Partner strategy - Sign partner/s after completion of phase III

5 5 Time line Q3 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Start of pivotal trial (PS) All patients included in the phase III program Start of 2 supportive phase III trials (IC & AC) Results in PS Results IC & AC 94% treated in PS Timeline and prognosis at program start (July 2006) Timeline and new prognosis September 2007 Marketing Partner(s) Filing Results from all studies Approval

6 6 Hepatitis C –opportunities to improve current therapy Efficacy – SVR superior to Pegasus/RBV –G1 treatment naïve: currently achieves ~45% SVR (of HCV infected in the US >70% has G1) –Non-responders –Genotype 2-6 Decrease treatment duration –Currently 48 weeks for most common and difficult-to-treat genotype 1 (G1) Safety – no added AE’s compared with Pegasus/RBV –Standard-of-care associated with severe side effects (flu-like symptoms, fatigue, depression, hemolytic anemia) –Contraindicated in patients with decompensated liver failure Dosing – once daily (q.d.)

7 7 Hepatitis C – Medivir/J&J program Process Partnership with Tibotec / Johnson & Johnson since November 2004 Phase I trials initiated February 2007 Pre-clinical data on TMC435350 presented in Glasgow at “14th International Symposium on Hepatitis C Virus and Related Viruses” September 9-13 Clinical phase Ia data on safety, tolerability and pharmacokinetics will be presented at the AASLD Liver Meeting in Boston 2-6th November. Patents Extensive and non-limiting IP published July 2005 Licensing agreement Rights to receive pharmaceutical product for Nordic countries from JNJ at pre- defined point in development Nordic rights retained by Medivir NS3/4A: Key protease for virus replication Enzyme inhibiting compound

8 8 HCV Direct Antivirals in Development J&J/Vertex VX-950 SGP Sch503034 Medivir/Tibotec Pre-clin Ph I Ph IIa Ph IIb PROTEASE INHIBITORS HCV-796 VPHM/Wyeth BILB-1941 POLYMERASE INHIBITORS Novartis Idenix NM-283 Ph III Gilead GS9132 ITMN-191 Roche/ITMN Tibotec Multiple Combination with PEG-IFN BMS? Abbott/Enanta Roche R-1626 XTL-2125 Roche/Pharmasset R-7128 (RO5024048) Boehringer NS5A INHIBITORS Arrow A-831 Phenomix GSK pyrrolidine Gilead GS9190 GNLB Biocryst Biota/BI Merck MK-0608 nucleoside Non-nucleoside ? ?

9 9 Medivir/Tibotec HCV PI Series Several series of highly potent NS3/4A inhibitors with strong IP developed Fine tuning of these inhibitors in collaboration with Tibotec Pharmaceuticals Ltd, J&J, has resulted in the selection of a Clinical Candidate, TMC435350 Enzymatic activity on genotype 1b/1b (Ki, nM) 0.3 nM Replicon activity on genotype 1b [IC 50, nM] 7.8 nM In vivo rat PK, Oral dose: 40 mg/kg T 1/2 (h) F (%) 2.6 45 Data on TMC435350 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

10 10 Rat exposure of TMC435350 Good systemic oral bioavailability Plasma exposure : C8h-plasma>EC99; liver exposure C24h-liver >EC99

11 11 TMC435350 Safety pharmacology Agar Ames assay: negative Mouse lymphoma assay: negative Mouse micronucleus screening assay: negative No effect on autonomic and behavioral parameters in mice up to 300 mg/kg (oral) and in rats up to 10 mg/kg in a Pharmascreen®

12 12 TMC435350 - Combination with IFNα in vitro Displays additive to synergistic effects with IFNa in cells combination with IFNa suppresses generation of TMC435350 resistance combination leads to >4 log 10 reduction in HCV RNA (9 days) in cells

13 13 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 Follow-on program in place with CD selection as next step Bone surface Osteoclast Cath K

14 14 Bone disorders (MIV-701) Market Approx 100 million patients in major growing markets (osteoporosis only) Strong interest in cathepsin K inhibition from major pharma companies Process Clinical phase Ia trials commenced March 2007 Phase Ib trials ongoing Results from the phase I trial late 2007 Patent/generic competition Patent applications being processed Expected patent protection until 2025 Partner strategy Establish industrial partnership after completion of phase I (2008)

15 15 Part 1 Groups A and BSingle dose male Fed and fasted Group CSingle dose female (PMW) Part 2 Group D and EMultiple dosing male 7 days Group FMultiple dose male 14 days Part 3 Group GMultiple dose PMW 14 days MIV-701 Phase I Study initiated March 2007 Completion during Q4 2007 Objective: Safety, tolerability, PK and biomarkers for efficacy

16 16 HIV – PI –Collaboration project with Tibotec / Johnson & Johnson MMP- COPD –Excellent results in pre-clinical disease model –Next step: selection of Candidate Drug Renin - Hypertension –IP compiled for three distinct and highly potent inhibitor series –Next step: studies in a pre-clinical hypertensive efficacy model Cathepsin S – RA, MS and pain –Potent and selective inhibitors –Efficacious in preclinical disease models –Fine-tuning of PK properties BACE – Alzheimer’s disease –High potency and selective inhibitor series identified –Optimization ongoing –IP filed “The Protease Discovery Engine” - A reliable repeat innovator

17 17 MIV-701 HEPATITIS C (TMS-435350) LIPSOVIR Key Events Going Forward Phase III data, Q1 2008 Partnership agreement(s) Market approval, 2008/09 Phase Ia data in November 2007 Start phase II trials Possibility to receive “approved drug”from Johnson & Johnson Phase I data late 2007 Partnership post phase I HIV FRANCHISE MIV-606 start of phase IIb trials New clinical trials and new data in other out- licensed projects Sales & marketing Product acquisitions, quids and co marketing 2008/09

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


Download ppt "Medivir September 2007 Lunch presentation at SHB CEO Lars Adlersson VP Research Bertil Samuelsson CFO / IR Rein Piir."

Similar presentations


Ads by Google