Vertex Pharmaceuticals won regulatory approval on Monday for a new hepatitis C drug, setting off a marketing battle with Merck over new drugs that are expected to improve the cure rate of the disease and shorten the duration of treatment.
Incivek, as the drug will be called, is expected to be the first big product for Vertex, and the first it will sell on its own. It is expected to allow the company to finally become profitable after 22 years in business and an expenditure of $4 billion.
Merck’s drug, Victrelis, was approved by the Food and Drug Administration on May 13.
The drugs “represent a new direction in the treatment of hepatitis C and a significant improvement over the current standard of care,” Dr. Margaret A. Hamburg, the commissioner of the F.D.A., said in a conference call on Monday.
Both products borrow from the strategy used by H.I.V. drugs of inhibiting the action of a viral enzyme — in this case, the hepatitis C protease enzyme.
In a clinical trial, 79 percent of people treated with Incivek combined with the existing treatment achieved what is effectively considered a cure, compared with 46 percent for those getting the existing drugs alone.
About half the patients treated with Incivek were able to finish treatment in 24 weeks instead of the usual 48 weeks. That is considered important because treatment, which involves the existing drugs alpha interferon and ribavirin, is arduous. Side effects can include flulike symptoms, anemia and depression.
Incivek has its own side effects, particularly a severe rash. It can also worsen anemia and cause nausea, fatigue and hemorrhoids.
Most analysts expect Vertex’s drug to reach annual sales of $2 billion within three years and to outsell Merck’s drug because it appears to be somewhat more effective in clinical trials, though the two drugs were never compared head to head. Also, the treatment using Vertex’s drug is less complex and requires six pills a day, half as many as required for Merck’s drug.
Vertex set the wholesale price of Incivek, also known as telaprevir, at $49,200 for the entire course of treatment. Merck’s Victrelis, also known as boceprevir, costs $26,400 to $48,400 depending on the duration of treatment. Both drugs would be used in addition to the standard therapy, which costs about $15,000 to $30,000 depending on duration.
“Cure is rare in medicine and that makes the economics very compelling,” said Joshua Boger, who founded Vertex. He stepped down as chief executive two years ago, but is still a director.
The new drugs could appeal to some people who were not cured by the existing treatments and might want to try again. One of those is Michael Desroches, 44, of Methuen, Mass., who said he already had cirrhosis. “It’s not going to get any better by itself, obviously,” he said.
Dr. Boger, who had been a chemist at Merck, started Vertex in 1989 with the aim of revolutionizing drug discovery. But it has been a costly and slow revolution and Vertex now finds itself competing with Dr. Boger’s former company. Vertex did develop two H.I.V. drugs that were sold by GlaxoSmithKline, and it has a couple of promising drugs for cystic fibrosis in development.
Vertex, based in Cambridge, Mass., started on the hepatitis C project in 1993, a few years after the virus was first identified. In 1996, it published the three-dimensional structure of the virus’s protease enzyme. Then it set about finding a chemical that could block the enzyme’s activity.
With the prospects for curing hepatitis C increased, efforts might shift to identifying more of the 3.2 million Americans said to be infected with hepatitis C.
Health authorities say most of those infected, primarily baby boomers who might have been infected decades ago by injecting drugs, or through sex or blood transfusions, do not know it. That is because it can take decades for liver problems to show up, and many times they never do.
Vertex is expected to start a public awareness campaign, with New York City being an initial focus. The company commissioned a study that made the case for screening all people 40 to 64 years old, not just those deemed to have risk factors.