Replies to post #98716 on Biotech Values

[DewDiligence]

JNJ/Medivir report that 79-86% of TMC435 patients in the four non-control arms of the phase-2b PILLAR study in the first-line setting stopped treatment at 24 weeks according to the response-guided protocol in the study:

http://finance.yahoo.com/news/Week24-Interim-Results-From-prnews-47168379.html?x=0&.v=1

The protocol of this study required that patients have undetectable VL from week 4 to week 20 in order to stop treatment at 24 weeks.

[DewDiligence]

More on the TMC435 PILLAR study (from the PR in #msg-56129587):

Small and transient bilirubin elevations (direct and indirect) were seen in the TMC435 150mg dose groups.

This is essentially the same language as in prior press releases; we’ll presumably have to wait for the actual AASLD presentation to know if there’s a safety problem here.

[DewDiligence]

Medivir Shares Gain on Interim HCV Data

[These 24w VL data are from a phase-2b trial called ASPIRE that tests SoC±TMC435 in the second-line setting and has 12- 24- and 48-week arms. Medivir’s own PR is in http://finance.yahoo.com/news/Medivir-Announces-Positive-prnews-1213323396.html?x=0&.v=2 , Medivir held a CC today to discuss the data. See the compilation in #msg-56688556 for other entries about TMC435.]

http://www.bloomberg.com/news/2010-11-18/medivir-gains-as-early-study-shows-drug-kills-hepatitis-c-virus.html

›By Frances Schwartzkopff - Nov 18, 2010

Medivir AB, the drugmaker competing to develop a new hepatitis C medicine, rose the most in four months in Stockholm trading after its drug reduced the virus to undetectable levels in patients who failed earlier treatment.

After 24 weeks, 86 percent of patients who had only partially responded to earlier treatment had undetectable virus levels after taking TMC435 alongside standard care, the Huddinge, Sweden-based company said in a study published today. That compared with undetectable levels in 19 percent of patients receiving a placebo. Shares rose as much as 9.2 percent.

Medivir is developing TMC435 with Tibotec Pharmaceuticals. The drugmaker, a unit of New Brunswick, New Jersey-based Johnson & Johnson, also is working simultaneously with Vertex Pharmaceuticals Inc. on a new hepatitis C drug. Vertex, based in Cambridge, Massachusetts, plans to seek U.S. approval for its medicine, Telaprevir, by the end of the year.

Medivir, which still needs to conduct the last trial needed to seek regulatory approval, said 78 percent of patients who didn’t respond at all to initial treatment had undetectable virus levels after taking TMC435, almost twice as many as those who received a placebo. [44% the “placebo” (i.e. SoC only) patients who were null responders in the first-line setting had undetectable VL at 24 weeks.]

The medication also led to undetectable virus levels in 94 percent of patients who had relapsed after receiving earlier care. That compared with 83 percent of patients taking a placebo. [For first-line relapsers, these interim data don’t mean much since the patients are highly likely to relapse again on SoC.] 462 patients participated in the 48-week study, with results taken half way through.

Medivir rose 8.5 kronor, or 6.8 percent, to 133.5 kronor at 12:54 p.m. local time. The advance gave the drugmaker a market value of 3.5 billion kronor ($511 million), its highest since December 2000.‹