Hepatitis C Treatment: New Drug Application by Vertex Pharmaceuticals

Posted by Mary Roberts
Wednesday, November 24th, 2010

Hepatitis C is bound to receive another treatment, as Vertex Pharmaceuticals Inc (NASDAQ:VRTX) just submitted Telaprevir to regulatory approval. The new drug application was submitted to the US Food and Drug Administration to reduce the FDA’s review time from 10 months to six months. After a 15-year effort to change the way hepatitis C is treated, the new drug is expected to increase chances for a viral cure to millions of people. Vertex Pharmaceuticals Inc., a small molecule drug developer, is looking for this priority review as to offer a better alternative to the 48-week course of interferon and ribavirin.

This comes at the same time with global drug giant Merck & Co. developing their own hepatitis C drug candidate that could compete with telaprevir for the same market. The investigational compound VX-950, or Telaprevir, attacks the enzyme protease, which aids replication of the hepatitis C virus. It is being developed by Vertex, along with Tibotec Pharma and Mitsubishi Tanabe Pharma. Vertex had begun submitting completed sections of the NDA to the FDA on a rolling basis around the middle of 2010.

The company’s application is based primarily on a trio of Phase III clinical trials that enrolled more than 2,000 patients. One trial showed that the new drug, in addition to standard meds, was able to essentially cure three-fourths of patients getting their initial round of therapy for hepatitis C infections. The second study showed that the drug could shorten the standard treatment time by half. A third trial proved the new treatment could cure two-thirds of patients who failed to respond to a prior round of therapy. Taken together, Vertex hopes the body of evidence in this application will pave the way for a completely new treatment strategy that will roughly double the cure rate of the existing regimen, while requiring patients to put up with fewer of the nasty flu-like symptoms implied by the current standard of care.

Safety and tolerability data were consistent across the three trials for the new drug, with mild-to-moderate rash and anemia being the more common adverse effects in the telaprevir trials.

With 6 million patients in the U.S. and Europe have hepatitis C, out of an estimated 170 million worldwide. Provided that Vertex gets the FDA approval, it will be the first major product for this company founded in 1989, which has accumulated a deficit of $3.26 billion through the end of September. If Vertex wins market clearance in 2011, the payoff could come relatively quickly. U.S. sales alone could amount more than $2 billion after a couple years because of the pent-up demand built for the drug during the clinical trial process, analysts say. Vertex’s market valuation yesterday was about $7 billion, based mostly on the projected value of this new treatment for hepatitis C. VRTC closed Monday’s trading at $34.25 on a volume of 1.65 million shares.

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Also See: Vertex Completes New Drug Application for Telaprevir for Hepatitis C