Thursday, May 30, 2013

Future Hepatitis C Blockbusters May Spawn Compulsory Generics

By Bloomberg on 7:53 pm May 30, 2013.
Category Health

Tags: hepatitis C, HIV/AIDS, pharmaceutical industry companies firms drug makers

Hepatitis C drugs like Gilead Sciences Inc.’s sofosbuvir, which analysts forecast will become the company’s top-seller, may spawn compulsory generics in countries that can’t afford them, according to a report backed by billionaire Richard Branson.

While health officials are negotiating with drugmakers including Gilead over the price of new medicines for the deadly liver virus, developing nations should issue so-called compulsory licenses for the therapies if price reductions aren’t sufficient, according to the report by the Global Commission on Drug Policy, of which Branson and former Federal Reserve Chairman Paul Volcker are members.

Under a World Trade Organization agreement known as trade- related aspects of intellectual property rights, or TRIPS, member countries can give licenses to generic-drug makers to make low-cost copies of treatments protected by patents that are needed to address a public health emergency.

“If the prices were to be unaffordable once more in history, it would be one more scandal around inequity of access to health care,” Michel Kazatchkine, the United Nations Secretary General’s Special Envoy on HIV/AIDS in Eastern Europe and Central Asia, said at a briefing in Geneva Thursday.

“There’s no reason why a country like Ukraine wouldn’t go for this and declare a public emergency.” Liver Damage About 170 million people are infected with hepatitis C, which is transmitted commonly among drug users who share contaminated needles, and can cause liver damage and cancer.

Of 16 million people estimated to inject drugs globally, about 10 million have hepatitis C, according to Thursday’s report, which didn’t specifically name sofosbuvir.

Spokeswomen for Gilead didn’t immediately respond to a call and e-mail requesting comment sent outside regular business hours.

Gilead applied for U.S. regulatory approval of sofosbuvir last month, and the drug may cost as much as $100,000 per patient, according to Mark Schoenebaum, an analyst at ISI Group in New York. The Foster City, California-based company gained the drug with its $11.1 billion acquisition of Pharmasset Inc. last year.

The pill may earn Gilead almost $4 billion in 2015 and $6.3 billion the following year, according to the average analyst estimates compiled by Bloomberg.

Johnson & Johnson, AbbVie Inc., Merck & Co., Bristol-Myers Squibb Co. and Vertex Pharmaceuticals Inc. are among other companies developing new hepatitis C treatments.


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