Replies to post #137839 on Biotech Values

[oc631]

I now have a small position in Medivir

[MVRBF.PK] Was the 950 shares that traded Friday your doing?

[oc631]

They do have a slightly later-stage pre-clinical nucleotide partnered with Janssen that is set to enter the clinic this year

My understanding is they are working on purine and pyrimidine nucleotides. Any idea which one is partnered?

I'm not 100% certain but I think they will be testing in additional genotypes in this trial; prior trials have only tested in genotype 1. If anyone listens to the CC, please clarify if this is your understanding as well.)

I'm not sure about the trial design [TMC435] but they claim sufficient activity in all genotypes except GT3.

I think you will do well with this company once battle lines between developers are drawn this year.

[hptaxis]

MEDIVIR SER B SEK5 (PINK:MVRBF) http://www.medivir.se/v4/en/index.cfm
Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 3 clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.

GF: http://www.google.com/finance?q=PINK:MVRBF

Financial Statement, 1 January – 31 December 2011
http://www.medivir.se/v4/en/ir_media/pressrelease.cfm
Cash flow from operating activities amounted to SEK 57.3 (-76.9) m; cash and cash equivalents and investments in securities etc. amounted to SEK 536.3 (647.2) m at the end of the period.


2010 AR
http://www.medivir.se/v4/images/pdf/2011/2010_Medivir_webb_E.pdf

[hptaxis]

Moreno C, Berg T, Tanwandee T, et al. Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2 to 6: TMC435-C202, a phase IIa, open-label study. J Hepatol. http://www.natap.org/2012/HCV/PIIS016882781200116X.pdf

BACKGROUND & AIMS: TMC435 is an investigational, once-daily, oral NS3/4A protease inhibitor currently in phase III development for the treatment of hepatitis C virus (HCV) infection. Phase I and II studies in patients infected with HCV genotype 1 have demonstrated that TMC435 is generally well tolerated, has a pharmacokinetic profile that supports once daily dosing, and demonstrates potent antiviral activity. This phase IIa study (TMC435-C202; NCT00812331) was conducted to investigate the antiviral activity, safety, tolerability, and pharmacokinetics of TMC435 in treatment-nasmall yi, Ukrainianve patients infected with HCV genotypes 2 to 6.

METHODS: The study consisted of 7 days of monotherapy with TMC435 (200 mg once daily). Patients could begin treatment with pegylated interferon/ribavirin from Day 8 with a follow-up period up to Days 37-42.

RESULTS: Thirty-seven patients were enrolled in Germany, Belgium and Thailand. For the primary endpoint at Day 8, the mean (+/-standard error) change in plasma HCV ribonucleic acid (log(10) IU/mL) from baseline was greatest for genotypes 6 (-4.35+/-0.29) and 4 (-3.52+/-0.43), followed by genotypes 2 (-2.73+/-0.71) and 5 (-2.19+/-0.39). No antiviral activity was evident for genotype 3. Viral breakthrough occurred in six patients during the monotherapy phase and in six additional patients during PegIFN/RBV-only period. All adverse events were mild or moderate and there were no discontinuations during the TMC435 monotherapy period.

CONCLUSIONS: The results of this phase IIa proof-of-concept trial provide evidence that TMC435 has a spectrum of activity against multiple HCV genotypes, except for genotype 3. In this study, TMC435 was generally safe and well tolerated.

[DewDiligence]

Thanks for the Medivir CC notes. The CC has uncommonly high information density, IMO.