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BMS and Tibotec plan all-oral hepatitis C regimen

Bristol-Myers Squibb to partner with J&J subsiduary for combination drug to elimate use of needles in HCV treatment

Bristol-Myers Squibb (BMS) has teamed up with Johnson & Johnson's (J&J) Tibotec subsidiary to develop a combination oral therapy for hepatitis C.

The therapy would combine BMS' daclatasvir (BMS-790052), an NS5A replication complex inhibitor, with Tibotec's NS3 protease inhibitor TMC435, which is partnered with Medivir.

The overall objective will be to develop a regimen based on oral treatment that could eradicate HCV without interferon alpha therapy, which requires injections.

Brian Daniels, senior vice president of development at BMS, said that the collaboration would "advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals."

Under the agreement, the two pharma companies will start a phase II study in the first half of next year to look at the combination's potential to achieve sustained viral response 12 and 24 weeks after treatment in patients with HCV genotype 1.

The study will look at three treatment regimens, including: a once-daily regimen of daclatasvir and TMC435 on top of pegylated-interferon alpha plus ribavirin; daclatasvir and TMC435 plus ribavirin; and daclatasvir and TMC435 alone.

It is notable that BMS has elected to partner with Tibotec for its NS3 protease inhibitor, as it has its own drug in this class - BMS-650032 - in clinical trials, including an ongoing phase III study looking at its use in combination with daclatasvir as an add-on therapy to pegylated interferon alpha-based treatment.

The first NS3 protease inhibitors to reach the market were Merck & Co and Vertex Pharmaceuticals' Victrelis (bocepravir) and J&J and Vertex Pharmaceuticals' Incivek (taleprevir), both of which debuted within a few weeks of each other earlier this year.

At the moment Incivek seems to be winning the launch battle, with sales of $421m in the third-quarter of 2011 compared to just $31m for Victrelis, although Merck claims to be gaining ground in terms of its share of new prescriptions.

Meanwhile, in addition to the combination study with TMC435 BMS is also testing daclatasvir in a phase III trial involving naïve hepatitis C patients, and as part of a triple-therapy regimen with BMS-650032 and its HCV polymerase inhibitor BMS-791325.

Tibotec is currently conducting two phase II trials for TMC435 in treatment-naïve and treatment-experienced HCV patients, with and without pegylated interferon alpha and ribavirin, according to its website.

5th December 2011

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