Big Pharma Knocked Out of the Box – Bristol-Myers’ Hepatitis C Blunder is an Enormous Bonus for Medgenics

Big Pharma Knocked Out of the Box – Bristol-Myers’ Hepatitis C Blunder is an Enormous Bonus for Medgenics

August 24th, 2012 // 11:42 pm @

Reflecting a nightmare for every pharmaceutical company, Bristol Myers Squibb (NYSE:BMY) halted all clinical trials for its NS5B polymerase inhibitor directed at hepatitis C after it came public that eight patients were hospitalized and one died during treatment. Quite a blow, considering not only that the disorder addresses a potential $20 billion market, but also that Bristol-Myers has to record a big charge – $1.8 billion for research and development related to its purchase of Inhibitex, developer of the nucleoside inhibitor, representing 72% of the price paid for the acquisition.

Making matters worse for other investigators in this area, the FDA could begin to look suspiciously on Gilead Sciences, Inc.(NASDAQ:GILD), which has three mid-to-late stage trials for the hepatitis virus using NS5B, and Vertex Pharmaceuticals (NASDAQ:VRTX), with an ongoing Phase II, also using the inhibitor. Recently, the FDA targeted Idenix Pharmaceuticals, Inc.(NASDAQ:IDIX) with a partial suspension of its trials of NS5B for hepatitis. Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) may also come under scrutiny for its Phase I with an NS5B inhibitor, for which it received a Fast Track designation by the FDA, a potentially embarrassing move by the agency, particularly when it was known earlier this month that Bristol-Myers patients were in danger and it took the death of a patient for the FDA to finally act.

With problems for its main competitors, Medgenics Inc. (AMEX:MDGN) stands to gain enormously. Its INFRADURE Biopump, with an FDA Orphan Drug designation for hepatitis D that is expected to accelerate approval for hepatitis C trials in the US, uses an entirely different method of treating the virus that does not involve an enzymatic process to kill its replication, using the patient’s own biological materials, enhancing safety. With further evidence of efficacy, Medgenics should pull into the lead with a treatment for this deadly epidemic.

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