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Vertex CEO preparing for '09 early telaprevir hepatitis C drug launch
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SAN DIEGO, June 19 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote,Profile, Research, Stock Buzz) will be prepared to launch its experimental hepatitis C drug next year even though U.S. regulators have not said whether they would review it based on a mid-stage trial, the company's chief executive said.
"That's Plan B," CEO Joshua Boger said late on Wednesday at an event at the BIO International Convention in San Diego.
He said Plan A continues to be completion of a pivotal trial of the drug, telaprevir, in hepatitis C patients not previously treated, with data expected in the first half of 2010. If positive, Vertex would then file for regulatory approval in the second half of 2010.
But the company "has to be ready," despite the expense, to launch in the third quarter of next year should the U.S. Food and Drug Administration agree to a faster timeline, Boger said.
Vertex last week reported positive interim results from a Phase 2b study of the drug in hard-to-treat patients who failed to respond to prior treatment, leading many observers to expect accelerated approval of the drug.
The interim results found 52 percent of the patients who received telaprevir as well as the standard interferon/ribavirin combination had undetectable levels of the hepatitis C virus after 36 weeks, compared with 30 percent of patients treated only with the standard therapy.
Boger said Vertex expects to take the final data from the trial to the FDA late this year or early next year.
Should the agency agree to review it, he said the application would be only for patients who have stopped responding to other therapies.
Boger said preparing Vertex to scale up for a launch next year is expensive, but needs to be done because having telaprevir on the market as soon as possible will save lives.
Hepatitis C is a viral infection of the liver. An estimated 170 million people worldwide are chronically infected with the hepatitis C virus, according to the World Health Organization.
Vertex is developing telaprevir in partnership with Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz). (Reporting by Deena Beasley; Editing by Braden Reddall)
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