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HCV Drug TMC649128 Enters Phase 1b

A new HCV polymerase inhibitor, TMC649128, is now being tested in a Phase 1b trial, the first stage of evaluating safety and efficacy in a large number of patients.

The advent of direct-acting antiviral agents will revolutionize treatment for hepatitis C virus (HCV) infection. The first 2 HCV protease inhibitors -- boceprevir (Victrelis) and telaprevir (Incivek) -- were approved last month.

While these drugs will initially be used in combination with pegylated interferon/ribavirin, the goal is all-oral regimens combining drugs that target different steps of the HCV lifecycle. TMC649128, a nucleoside analog, is one of several HCV NS5B polymerase inhibitors under study.

Below is an edited excerpt from a press release describing the new trial issued by Medivir, which is developing TMC649128 in collaboration with Tibotec, now known as Janssen.

TMC649128 Enters Phase Ib Trial in Patients Chronically
Infected with Genotype 1 Hepatitis C Virus

Huddinge, Sweden -- June 22, 2011 -- Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase Ib clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus (HCV) infection.

TMC649128 is a nucleoside NS5B polymerase inhibitor developed in collaboration with Tibotec Pharmaceuticals. TMC649128 has demonstrated an attractive pre-clinical profile and displays in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance. A clinical phase Ia double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers has now successfully been completed.

The TMC649128 phase Ib study that now is underway is a double-blind, randomized and placebo-controlled trial in genotype 1 HCV-infected patients to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of multiple ascending doses of TMC649128 given as monotherapy and in combination with pegylated interferon and ribavirin.

It is anticipated that TMC649128 will be used in combination with other HCV direct acting antiviral agents, given its high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.

"We are delighted to see TMC649128, our first HCV nucleoside inhibitor, advance into clinical phase Ib studies in HCV patients", stated Bertil Samuelsson, CSO of Medivir. "The start of this phase Ib trial underscores our commitment to develop new and innovative treatments for hepatitis C infected patients. We view nucleoside inhibitors, such as TMC649128, and protease inhibitors, such as TMC435, as cornerstone components of future direct acting antiviral combinations for HCV therapy."

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese/Xerclear. Medivir's key pipeline asset, TMC435, a protease inhibitor, is in global phase 3 clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.

For more information about Medivir, please visit the Company's website:


Medivir AB. TMC649128 enters Phase Ib Trial in Patients Chronically Infected with Genotype-1 Hepatitis C Virus. Press release. June 22, 2011.


























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