Thursday, November 18, 2010

Medivir/Tibotec's TMC435 looking good in partial and non-responders....

This should get interesting in terms of revenue streams - Medivir is developing TMC435 with Tibotec who will market the drug in the US. Tibotec has marketing rights for Telaprevir everywhere except North America and the Far East. Telaprevir will be out first, depending on how things go with the European regulatory folks. How Tibotec prioritizes TMC435 development with Telaprevir marketing abroad is unclear. Looks like a darn good drug though. Good numbers and QD dosing.

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.

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. 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.

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