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AZT Patent Expires
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"Cheaper AZT on the way"
Raleigh News and Observer
By SABINE VOLLMER
One AIDS drug is about to get a little cheaper.
AZT, the chemical needed to make the AIDS treatment Retrovir, lost its patent protection Saturday, and generic versions are expected to be on the market soon.
Generic drugmakers in China, India and Africa started gearing up to make generic AZT in July.
Those drugs are expected to cost about $105 for a year's supply, about 20 percent less than the cheapest AZT drug available. In the United States, AZT is only available as Retrovir, which is made by GlaxoSmithKline.
The British drugmaker, which has a U.S. headquarters in Research Triangle Park, charges $3,893.64 wholesale for a year's supply of Retrovir.
The drug was a best-seller for Burroughs Wellcome -- a predecessor of GSK. It has generated about $4 billion in sales since becoming available in 1987, according to GSK financial reports.
Newer, more powerful AIDS drugs have made Retrovir less important for GSK since the late 1990s.
The company doesn't expect the patent expiration to hurt overall revenue because it won't affect the price of Combivir and Trizivir, two of its newer drugs that contain AZT. In 2004, Combivir and Trizivir generated a combined $1.6 billion in sales.
But a cheap, generic AZT is expected to affect HIV/AIDS treatment in developing countries.
The U.S. Food and Drug Administration tentatively approved the first request to make generic AZT two weeks ago. The request was filed by Indian drugmaker Aurobindo Pharma. The FDA declined to say how many more requests are pending.
The impact in the United States depends on how much cheaper generic AZT will be than Retrovir, said Steve Sherman, coordinator for North Carolina's AIDS Drug Assistance Program. The program, financed by the state and federal government, helps provide free AIDS medication to low-income people with HIV.
But many states' AIDS drug programs lack the money to help all applicants. North Carolina's, for example, has about 800 people in a program that will run out of money in the next six months. Another 200 are on a waiting list.
So even small savings help, Sherman said. "Any nickel we're able to save on one drug allows us to serve more clients and provide more medication."
The development of AZT through the years
1964: Jerome P. Horwitz, a chemistry professor at Wayne State University in Detroit, synthesizes azidothymidine hoping the chemical will stop tumor cells from growing; AZT flops as a cancer drug
1981: The Centers for Disease Control report an alarming rate of a rare cancer in gay men
1982: The CDC names the new disease Acquired Immune Deficiency Syndrome, or AIDS
1983: Human immunodeficiency virus, or HIV, is identified as the cause of AIDS
1984: Burroughs Wellcome scientists discover AZT's ability to slow the progression of AIDS
1985: Burroughs Wellcome files a patent application to protect its rights to AZT
1987: The FDA approves AZT as the first AIDS treatment. Burroughs Wellcome brings AZT to market as Retrovir
1989: Four AIDS activists barricade themselves in an office at Burroughs Wellcome's RTP headquarters to protest the costs of AZT
1991: Consumer activists and two generic drugmakers sue Burroughs Wellcome, questioning the company's exclusive rights to make and sell AZT
1995: Glaxo Wellcome receives regulatory approval for its second AIDS drug, which is sold as Epivir, and Swiss drugmaker Hoffman LaRoche receives approval for the first protease inhibitor
1996: The AIDS drug cocktail is born. The U.S. Supreme Court lets stand a ruling that affirms Burroughs Wellcome's AZT patent
1997: The FDA approves Combivir, Glaxo Wellcome's first combination drug containing AZT
1999: Glaxo Wellcome markets its first protease inhibitor.
2000: The FDA approves Trizivir, Glaxo Wellcome's second combination drug containing AZT
2005: Duke University becomes the headquarters of the Center for HIV/AIDS Vaccine Immunology, a $300 million, nationwide effort that will draw on a consortium of universities and medical centers to solve problems in developing an HIV vaccine. A researcher at University of North Carolina at Chapel Hill experiments with eliminating HIV from an infected cell. The patent for AZT expires.
Sources: GlaxoSmithKline, The Chronicle of Higher Education, News & Observer research.
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