Vertex Hepatitis Drug Is Approved

In a major advance for people with hepatitis C virus, FDA has approved Vertex Pharmaceuticals’ Incivek, a protease inhibitor that, when added to the current treatment regimen, significantly improves hepatitis cure rates. Earlier this month, Merck & Co. got the regulatory nod for its own protease inhibitor, Victrelis, setting up for a battle over the HCV market.

The first drug launched out of Vertex’ labs, Incivek is the culmination of more than 20 years of work and some $4 billion in R&D investment, CEO Matthew W. Emmens told analysts on a call to discuss the approval. “Our researchers didn’t pick an easy disease to tackle,” he said.

Industry watchers have been expecting Incivek, known generically as telaprevir, to be more successful than Victrelis (boceprevir). Although the two drugs have never been tested in a head-to-head trial, clinical studies suggest that the Vertex drug is more effective at eradicating the infection and works faster.

Now, with more information on how FDA will allow the drugs’ use, their relative prices, and the companies’ marketing strategies, the competition is shaping up. Incivek will cost $49,200 for the full treatment course, and Victrelis will cost between $31,000 and $44,000. Vertex and Merck have unveiled assistance programs to offset the co-pays that insured patients will face.

“Based on our examination of the labels, we think Incivek could be viewed to have a meaningful edge,” Leerink Swann stock analyst Howard Liang told investors. He added that the drug would be taken for a shorter period and with fewer pills per day. Unlike Victrelis patients, most Incivek patients do not need to take additional medicine for drug-related anemia.

The stakes in the HCV market are high: ISI Group analyst Mark Schoenebaum estimates Incivek alone will bring in $1.75 billion in sales in 2012.

Merck, however, is hoping to gain an advantage by marketing its drug in combination with the existing HCV regimen, PEGylated interferon and ribavirin. The company recently unveiled a pact with Roche, which will promote Victrelis alongside its PEGylated interferon product, Pegasys.