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Vertex pitches hepatitis drug to key doctors

By Robert Weisman
Globe Staff / November 2, 2009

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With thousands of gastroenterologists and hepatologists converging on Boston for this week’s annual meeting of the American Association for the Study of Liver Diseases - a forum known as “the liver meeting’’ - a Cambridge biotechnology company is preparing a show of force to highlight its drug to treat the hepatitis C virus.

Researchers for Vertex Pharmaceuticals Inc. will make no fewer than three data presentations at the meeting. One scheduled for tomorrow will outline studies showing that, in clinical trials, more than 80 percent of hepatitis C patients using a treatment regimen based on Vertex’s drug, Telaprevir, achieved a “sustained viral response,’’ meaning the drug removed the virus from their bodies.

“It’s a very important opportunity for us to provide our data to the medical community,’’ said Matthew Emmens, who this year became Vertex’s chief executive. “It’s highly anticipated data, and these are unprecedented numbers. If you have a highly effective compound, the world beats a path to your door.’’

This week’s presentations by Vertex and rival companies developing treatments for liver disease are part of a larger effort to raise awareness of hepatitis C, a largely untreated virus estimated to affect about 3 million Americans and 100 million people worldwide.

A large percentage of those infected with hepatitis C don’t know they have the virus; many got it from injecting drugs or receiving blood transfusions years ago before steps were taken to safeguard the blood supply. If left untreated, the virus can lead to liver scarring or cancer.

Last week, a coalition of lawmakers introduced a bill in the US House of Representatives that would give $90 million to the Centers for Disease Control and Prevention to support state health departments in prevention, immunization, and surveillance of hepatitis C.

Dr. Raymond Chung, chief of hepatology at Massachusetts General Hospital, said such companies as Vertex and New Jersey drug maker Schering-Plough Corp. are developing protease inhibitors as “an add-on strategy’’ for battling hepatitis C.

In contrast to interferon treatments on the market - which block cellular genes that host hepatitis C - protease inhibitors such as Telaprevir act directly against the virus.

They also work effectively with interferons in drug “cocktails,’’ mixtures of treatments.

“For some time, there has been the promise of progress beyond the current standard of care,’’ Chung said. “We are on the threshold of this advance with the introduction of hepatitis C virus protease inhibitors. Ultimately, this will be a very attractive concept.’’

Vertex and Schering-Plough, which has been developing its protease inhibitor, Boceprevir, to compete with Telaprevir, are in Phase 3 clinical trials - the last step before seeking approval from the Food and Drug Administration to market a drug. Vertex plans to file its application in the second half of next year and expects to receive FDA approval by the second half of 2011.

Schering-Plough, which also is reporting data at three sessions during this week’s meeting, hasn’t predicted when it might file an application for its compound. “From everything either company has said publicly, you’d have to conclude that the programs are basically in the same place,’’ said Robert Consalvo, a Schering-Plough spokesman.

Consalvo said his company markets a combination of two drugs, PegIntron and Rebetol, as interferon treatments for hepatitis C, competing with Swiss drug maker Roche AG in that market. If the FDA approves Boceprevir, it could be used in a three-drug combination with PegIntron and Rebetol.

Several other biopharmaceutical companies are in earlier stages of developing hepatitis C drugs. Swiss drug giant Novartis AG, whose global research headquarters is in Cambridge, last week decided not to move forward with an option to license a hepatitis C drug being developed by Idenix Pharmaceuticals Inc. of Cambridge.

Telaprevir, meanwhile, has become key to Vertex’s two-decade quest to become a company that develops, produces, and markets a pipeline of drugs.

Vertex, founded in 1989 by legendary researcher Joshua Boger, previously developed Lexiva, a protease inhibitor for HIV, but licensed it to the British drug giant GlaxoSmithKline, which now markets it worldwide.

Telaprevir would be the first drug Vertex would market itself, and it is expected to finally make the company profitable.

“The plan was always to become a fully capable company in research and development, manufacturing, and commercialization,’’ Emmens said. “You develop it, you make it, and you sell it.’’

Emmens, who worked with Boger years ago at pharmaceutical giant Merck & Co., went on to become chief executive of the Irish drugmaker Shire PLC. Boger invited Emmens to sit on the Vertex board in 2004, and he joined the company as its president last February. Emmens was named chief executive in May.

Part of his charge will be to build a sales force at what primarily has been a research company. Toward that end, Emmens has begun the process of hiring about 200 salespeople in anticipation of marketing Telaprevir and other drugs.

The company has hired more than 160 people this year and about 800 over the past four years. It has about 1,400 employees, including about 1,100 at its Cambridge campus.

Robert Weisman can be reached at weisman@globe.com.