AEGiS-WSJ: China Approves Production Of Generic AIDS Drug

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

China Approves Production Of Generic AIDS Drug

Wall Street Journal - September 16, 2002
Leslie Chang, Staff Reporter of The Wall Street Journal

BEIJING -- Chinese authorities have approved domestic production of another AIDS drug, showing how the country's generic-drug makers are taking advantage of lax patent laws to produce medicines still under patent overseas.

Shanghai Desano Biopharmaceutical Co., a closely held company, said it got approval from the country's State Drug Administration to generically produce and sell ddI, one of the patented drugs used in a cocktail therapy to slow the spread of HIV, the virus that causes AIDS.

Unlike another AIDS drug, AZT, which was approved for domestic production by a different company last month, ddI is still under patent protection in China. But because of patent-law loopholes, a slight tweak in formulation between Desano's version and that of ddI's developer, Bristol-Myers Squibb Co. of New York, means that in China, the generic version doesn't violate any patents.

"We are using a different formulation," said Amy Guo, general manager for the Beijing subsidiary of Shanghai Desano, which already manufactures the raw materials for AIDS drugs for export. "They use tablets, we use powder."

The approval for ddI came "earlier than we expected," said Ms. Guo, adding the company hopes that applications to produce two other AIDS drugs would soon be approved. Together, that would allow patients in China to obtain a year's supply of the cocktail therapy for between $400 and $600, said Ms. Guo. The big pharmaceutical companies, after responding to pressure within and outside China to lower prices, currently offer the cocktail combination in China for about $3,500 a year.

A spokeswoman at the State Drug Administration said that the office approves new drugs all of the time and couldn't comment on specific cases.

Che Fei, a spokeswoman for Bristol-Myers Squibb, said the company wasn't aware of the approval granted Desano. "We really don't know how Desano produced ddI, so we can't tell if they have violated our patent or not," she said.

Write to Leslie Chang at leslie.chang@feer.com

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