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Bristol-Myers gains FDA's 'breakthrough' track in race for hep C drug approval

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Bristol-Myers Squibb ($BMY) just gained an inside regulatory track in the frantic race to get new interferon-free hepatitis C drugs to the FDA. The big biotech reported in its quarterly statement that the agency has provided the coveted "breakthrough" status for a combination of daclatasvir with two other direct-acting antivirals, asunaprevir, an NS3 protease inhibitor and BMS-791325, an NS5B non-nucleoside polymerase inhibitor.

The combo approach is designed to stop the virus from replicating. Just days ago the company reported that the drug worked in 15 of 16 patients during a 24-week trial. Now investigators plan to settle on an ideal dose and launch a late-stage study later this year.

BMS is the latest in a long line-up of high-profile biopharma companies to land a breakthrough designation. In theory, the agency is committed to working with these companies now to expedite a path through the FDA and on to the market--possibly granting an accelerated approval ahead of a traditional pivotal study. In practice, there's still not much of a track record to demonstrate exactly what kind of advantage, if any, will be provided.

One thing, though, is certain. The roster of companies to win breakthrough status also includes Merck ($MRK), Novartis ($NVS), Johnson & Johnson ($JNJ), Vertex ($VRTX) and others--all well-established companies with a very long track record in R&D. So far, no small biotechs have made it to the list, indicating that at least initially regulators are staying in their comfort zone when it comes to who they want to work with.

The breakthrough designation also reflects a certain kind of vindication for BMS, which saw its newly acquired hep C drug 094 blow up in the clinic, killing one patient and injuring others. The company is behind Gilead ($GILD) and AbbVie ($ABBV) in this race--but it is gaining ground. 

BMS has also achieved a fast-track designation for nivolumab, its PD-1 cancer drug in late-stage development. That therapy remains the company's most exciting therapy in late-stage development, according to a number of analysts who track Bristol-Myers.

- here's the release on the Q1 numbers

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