1 / 18

Medivir September 2007 Lunch presentation at SHB

Delve into Medivir's latest updates in pharmaceutical research, development, and market strategy, including Hepatitis C and other key projects and events.

zytka
Télécharger la présentation

Medivir September 2007 Lunch presentation at SHB

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

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

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

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

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

  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. Hepatitis C – Medivir/J&J program NS3/4A: Key protease for virus replication 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 Enzyme inhibiting compound

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

  9. Medivir/Tibotec HCV PI Series Data on TMC435350 • 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 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. Rat exposure of TMC435350 Good systemic oral bioavailability Plasma exposure : C8h-plasma>EC99; liver exposure C24h-liver >EC99

  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. TMC435350 (0.6x EC50) IFNα (1XEC50) 0 TMC435350 (0.6xEC50) + IFNα (1xEC50) -0.5 -1 IFNα (10xEC50) -1.5 TMC435350 (6xEC50) -2 Log HCV RNA change vs non treated control (normalized to RPL13A) -2.5 TMC435350 (6xEC50) + IFNα (1xEC50) -3 -3.5 -4 -4.5 -5 0 3 6 9 days TMC435350 - Combination with IFNαin vitro • Displays additive to synergistic effects with IFNa in cells • combination with IFNa suppresses generation of TMC435350 resistance • combination leads to >4 log10 reduction in HCV RNA (9 days) in cells

  13. Bone disorders (MIV-701) Bone surface • 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-dailyoral dosing • Strong Follow-on program in place with CD selection as next step Cath K Osteoclast

  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. MIV-701 Phase I Study initiated March 2007 Completion during Q4 2007Objective: Safety, tolerability, PK and biomarkers for efficacy

  16. “The Protease Discovery Engine” -A reliable repeat innovator 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

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

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

More Related