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Merck and Roche team up for hepatitis C studies

Pharma companies to test marketed and investigational drugs in series of clinical trials

Merck & Co and Roche have agreed to collaborate on a series of clinical trials that will test their marketed and investigational drugs for hepatitis C virus (HCV) in combination.

The first study will look at a regimen based on Merck's recently-approved oral NS3/NS4a inhibitor Victrelis (boceprevir) alongside Roche's investigational NS5B inhibitor mericitabine (RO5024048) and already-marketed drugs Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).

The phase II study - called DYNAMO 1 - will enrol adult patients with HCV genotype 1 infection who have failed to respond to prior treatment with peginterferon alfa/ribavirin therapy.

Merck and Roche first started working together in HCV in May, with Roche now promoting Victrelis globally as part of a triple regimen with Pegasys and Copegus.

The two companies' decision to join forces comes at a time when momentum is building behind a new wave of hepatitis C drugs, particularly oral therapies that could lead to treatment for HCV that does not require injections.

As was the case with HIV, companies developing HCV therapies are looking at various combinations of drugs in order to deliver a sustained viral response and make treatment simpler and more convenient for patients.

Merck's agreement with Roche taps into the latter's expertise as an established player in the increasingly competitive HCV market,

Victrelis was approved for marketing earlier this year, and posted sales of $31m in the third-quarter. It is however lagging behind rival drug Incivo/Incivek (talepravir) from Vertex Pharmaceuticals, which made nearly $420m in the third-quarter despite being launched at around the same time.

Meanwhile, a range of other new HCV drugs are coming through the pharma industry's pipelines, including Novartis and Debiopharm's DEB025, Boehringer Ingelheim's BI 201335, Bristol-Myers Squibb 's BMS 650032, and Johnson & Johnson/Tibotec's TMC435, all of which are in phase III testing.

Roche's mericitabine is partnered with Pharmasset, which is currently the focus of an $11bn merger bid from Gilead Sciences.

"The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform Victrelis provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection," commented Eliav Barr, vice president of infectious diseases project leadership and management at Merck Research Laboratories.

16th December 2011

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