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Gilead Gives Up Trade Secrets to Get AIDS Drugs to Poor Nations
 
 
  Aug. 7 (Bloomberg) -- Gilead Sciences Inc., maker of the world's best-selling AIDS treatment, is offering to help generic- drug makers in India produce the medicine, a move intended to get the life-saving pill to millions more people in the world's poorest countries.
 
Since 2004, Gilead has twice slashed its price for Truvada, a drug that combines the company's best-selling pill, Viread, and another medicine. Gilead now sells Truvada to poor African nations for 87 cents a day, compared with $24.51 in the U.S.
 
Still, only 45,000 to 50,000 of the 6.5 million people in poor countries who need AIDS drugs to stay alive are receiving any of Gilead's medicines. To get the drug to more patients, Gilead is handing over its manufacturing secrets to generic companies who may be able sell the drugs for even less.
 
``We think they can beat our prices and we would love to see that happen,'' said Gregg Alton, Foster City, California-based Gilead's general counsel, who is working on the negotiations with 10 Indian drugmakers. ``We're going to teach them everything they need to know to make the product.''
 
About 83 percent of patients at the stage of needing treatment aren't getting drugs in Africa alone, where 24.5 million people are infected with HIV, according to the United Nations' UNAIDS program. About 38.6 million people worldwide have HIV/AIDS and 25 million have died from the virus since the disease was identified in 1981.
 
Gilead's offer to help generic companies manufacture their products represents the latest step by drugmakers to increase access to AIDS therapies. Previously, in addition to cutting prices, drug companies had granted permission to generic makers to copy medicines. They also promised not to defend patent rights.
 
`Huge Change'
 
``It's a huge change,'' said Helene Gayle, former director of the HIV program at the Bill & Melinda Gates Foundation and now chief executive officer of Care, a non-profit organization that works with impoverished women. ``We just haven't seen this kind of willingness to cooperate before.''
 
The obstacles to getting HIV medicines, such as prices that remain too high for many poor patients and trade barriers that thwart distribution, will be among the topics discussed at the 16th International AIDS Conference that begins Aug. 13 in Toronto. The six-day meeting will draw about 24,000 doctors, advocates and others to discuss treatment, care and prevention of the disease.
 
Trade Secrets
 
Among the AIDS-drug manufacturers, New York-based Bristol- Myers Squibb Co. and Basel, Switzerland-based Roche Holding AG say they are pursuing similar deals that involve handing over proprietary production data. Bristol-Myers says it will assist two manufacturers, closely held India-based Emcure Pharmaceuticals Ltd. and South Africa's Aspen Pharmacare Holdings Ltd., to help them make copies of its AIDS pills.
 
``We didn't just send them the owner's manual, but we also sent them our technicians to work in their labs,'' said Donne Newbury, director of global HIV access programs at Bristol-Myers and a native of South Africa. ``We have our scientists working there, and they've been to visit our manufacturing sites.''
 
Bristol-Myers also will grant licenses to other drugmakers who want to figure out on their own how to make the drugs, Newbury said.
 
``The HIV epidemic is so dramatic that it has resulted in us doing very unusual things,'' she said.
 
The decision to relinquish so much information to generic drugmakers, long considered a threat by brand-name manufacturers, is significant, said Gayle, who is co-chair of the conference in Toronto.
 
Progress
 
``Even though access has expanded greatly, still most of the people around the world who need antiretroviral medicines aren't yet receiving them,'' Gayle said. ``We still have a long way to go, even though we've made tremendous progress.''
 
The interests of shareholders in U.S. and European brand- name drugmakers limit the amount of medicine the companies can sell at prices that don't earn a profit, said Anil Soni, director of pharmaceutical services for the New York-based Clinton Foundation. Gilead had sales of $1.39 billion last year from Truvada and the company's other AIDS medicines.
 
``Generic companies work on a different business model and their shareholders have different expectations,'' Soni said.
 
Gilead officials say the new initiative builds on an approach pioneered in 2002 by the Clinton Foundation, an organization started by former President Bill Clinton. By giving away the patent and helping the Indian companies make the drugs, Gilead is hoping to drive down prices by fostering competition.
 
Lower Costs
 
``We set out to work with, not against, the manufacturers,'' the foundation's Soni said.
 
Under the agreements with Gilead, the Indian drugmakers won't be allowed to sell the medicines outside of the world's poorest countries. The drugs will have a different look than Gilead's version to thwart sales in richer countries.
 
In the U.S., Truvada is often used in newly diagnosed patients in combination with Bristol-Myers's Sustiva. The companies are now selling a single pill in the U.S. that combines Truvada and Sustiva.
 
Matrix Laboratories Ltd. of Secunderabad, India, says it is gearing up with Gilead's support to make its own version of Truvada. The company's scientists have already figured out how to make the treatment's active ingredients without Gilead's help, said Srini Vasan, senior vice president for business development.
 
Gilead's advice might help the company make some improvements to its manufacturing process, Vasan said. He said Matrix expects to finalize a licensing agreement with Gilead in the next month or two and begin selling copies of Truvada by early next year. He declined to say how much Matrix will charge for the drug.
 
``It's a departure from earlier and from what had been the case with other drugs,'' Vasan said. ``This is more and more likely to happen in the future.''
 
 
 
 
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