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Read about Medivir's strategic moves in therapeutic areas, partnership structures, and revenue sources. Explore upcoming trials, operational focus, and potential acquisitions for 2008.
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The presenters from Medivirat the Carnegie lunch January 21 Lars Adlersson CEOProf Bertil Samuelsson, VP Discovery and ResearchRein Piir, CFO / IR
Stabilizing the business by entering new therapeutic areas 2 2 3 3 3 1 2 2 1 1 1 1 1 1 1 2 1 2 3 3 1 2 1 2 1 2 2 1 2 1 2 1 2 2 2 3 • 90% of 2007 deal value is linked to protease based projects • 100% of internal resources are invested in protease based projects, Lipsovir being the only exception Lipsovir Protease based Polymerase based (HIV Franchise & HCV Pol)
Stabilizing the business by adding a mix of partnership structures
Future potential sources of revenues Existing license agreements Potential new license agreements Pharma Sales QUID(S) HEPATITIS C PI (TMC 435350) LIPSOVIR HIV PI MIV 701 & new cathepsin K inhibitors CO-PROMOTION ACQUISITIONS HIV Franchise Partners Late Discovery Projects (COPD ) Other Discovery Projects (BACE, Renin and cathepsin S) Future revenues will be used to finance operations towards profitability and to build pharma sales
TMC4353350 - Phase IIa Clinical Trial • The OPERA-1 trial will assess the number of patients that achieve RVR (undetectable virus at week 4) • The OPERA-1 trial will be able to assess number of patients achieving SVR (after 4 weeks of combo therapy plus 24 or 48 weeks of IFN plus RBV) • The Phase IIa RVR data available already H1 2008, will initiate the design and start of the phase IIb trial (OPERA-2) • Statement - There is a place for next generation HCV PI like TMC435350 with: • High potency – low drug load • Once-daily – good compliance resulting in increased efficacy • Large forgiveness factor – higher efficacy • Less side effects – possible from shorter duration of treatment • More treatment options – exclude ribavarin from therapy
Operational focus and activities 2008 1(2) LIPSOVIR • First to prevent outbreaks of cold sores? • Phase III results available late Q1 2008 • Partnering discussions ongoing • The aim is to have the commercial strategy, including • partner/s in place by the end of 2008 • First regulatory approval is expected H1 2009 • Phase Ib completed with excellent results – to be presented • in April • Phase IIa initiated – results will probably be presented in Q4 • Phase IIb could start before year end HEPATITIS C (TMC-435350) • Broad preclinical program – follow-on candidate drug • to be selected during the spring • The partnering process will be initiated shortly CATHEPSIN K (MIV-701) COPD, Renin, BACE etc • Evaluate interest for broad partnerships
Operational focus and activities 2008 2(2) • Portfolio sourcing exercise has begun • Co-marketing discussions with a few selected companies initiated • Infrastructure can be put in place with short notice PHARMA SALES • Two phase IIb trials with Valomaciclovir recently initiated • Head-to-head vs market leader for shingles – once daily vs three times daily • and for the treatment of acute infectious mononucleosis • Chinese condom coating initiative well underway HIV FRANCHISE • Cash end-of 2007 ~SEK 370m • Substantially lower expenses level (appr. SEK 190m) during 2008 • Future revenues will be used to extend runway and build • pharma sales FINANCE