Biotech Values

[mcbio]

Medivir @ EASL (4/21/12 slide presentation)

(Link to slides at: http://www.medivir.se/v4/en/ )

1. Slide 2 - 15 marketed products in Nordics generating annual sales of Euro60M (EBITDA ~Euro12M). Aiming for profitability in a few years.

2. Slide 6 - Aiming for candidate selection of unpartnered HCV nuke(s) in 4Q12. Medivir has both purines and pyrimidine nukes that have properties similar to most advanced nukes (assuming GS-7977 here). Unpartnered NS5A inihibitor at pre-clinical optimization phase. Partnered nuke w/JNJ/Tibotec selected and IND prep activities ongoing (supposed to enter Phase 1 this year; not sure how this one compares to unpartnered nukes).

3. Slide 7 - TMC435 has activity against GTs 1,2,4,5,6.

4. Slide 14 - ASPIRE adverse events for TMC435:
A. AEs leading to discontinuation - 9% for TMC435 vs. 5% for placebo arm.
B. Grade 3/4 AEs - 36% for TMC435 vs. 26% for placebo arm.
C. Photosensitivity AEs - 6% for TMC435 vs. 2% for placebo arm.

[Not sure if you have any concerns here; obviously in the future the placebo arm components will presumably be dropped from combo treatment, thus decreasing overall AEs. All told, any concerns with TMC435 AEs here, though?]

5. Slide 21 - Cirrhotic patient data largely missing (from trials to date). These are most difficult patients to treat and make up substantial portion of available patient pool. SVR36 may be needed to capture real life relapse rate in IFN-free (and ribavirin?) setting. Ribavirin will not be part of future HCV combos due to severe side effects and safety issues.

6. Slide 22 - goal for next gen treatment is 2 DAAs in combo (I actually don't like this assertion as I think it puts more pressure on Medivir and TMC435. I think TMC435 could most assuredly find a home in a 3-drug cocktail but if only 2 then that obviously narrows the window and opportunity. I doubt GILD will use TMC435 in an HCV DAA combo so that perhaps puts a lot of pressure on Medivir to hope that BMY will need to use TMC435 with either daclatasvir or BMS-094. If not, Medivir will have to find someone else or hope to pair TMC435 with their nuke partnered w/JNJ or one of their unpartnered ones, though all of those are far behind.}

7. Slide 23 - 37% of patients in the ASPIRE trial were in the two most difficult to treat cirrhotic patient groups (F3/F4).