Gilead, Glaxo Pills for HIV Approved

From Bloomberg News

Gilead Sciences Inc. and GlaxoSmithKline on Monday won the first Food and Drug Administration approval to sell once-a-day HIV medicines that combine two medicines into single pills.

The agency cleared Gilead’s Truvada, which contains the company’s Viread and Emtriva drugs. Glaxo’s Epzicom, a combination of Ziagen and Epivir AIDS drugs, also won approval.

The new medicines will simplify treatment for patients, the FDA said. Combination drugs make it less likely that people will skip doses and develop resistance to the treatments. The market for HIV therapies will be worth an estimated $7.9 billion this year, according to analysts at Lehman Bros.


“These are the first one-pill, once-a-day combinations,” said Eric Schmidt, an analyst at SG Cowen & Co. who follows Gilead. “These are groundbreaking approvals in HIV.”

Both drugs were approved for use with other AIDS medicines, such as Bristol-Myers Squibb Co.'s Sustiva. Patients generally take a regimen of three types of medicines to control HIV.

Gilead, based in Foster City, Calif., priced Truvada at $650.83 for a 30-day supply in the U.S. The company will begin shipping the medicine to wholesalers by the end of the week, said Chief Financial Officer John Milligan. Glaxo said its medicine would cost $621.60 for a one-month supply.

Shares of Gilead fell $1.14 to $63.50 in Nasdaq trading. Glaxo’s shares rose 26 cents to $41.21 on the New York Stock Exchange.

Simplified combination treatments may also be more useful in developing countries, where patients have less access to routine medical care. President Bush’s emergency AIDS treatment plan calls for the U.S. to fund treatment for people in Africa and Asia over the next five years.

Gilead, which began a program to offer discounted drugs in 68 developing countries in April 2003, plans to offer Truvada for 99 cents a day. The drug will be available in developing nations within a month, Milligan said.

The introduction of the new medicine will help Gilead increase sales of its AIDS medicines to as much as $875 million this year, the company said last week. Peak sales of the company’s HIV treatments may eventually reach as much as $2 billion a year, said SG Cowen’s Schmidt.

Glaxo is the world’s leading maker of AIDS medicines. The British company reported sales of $2.76 billion last year for HIV drugs.

The company sells six HIV medicines and was the first to sell a combination pill, Combivir. Combivir and another combination pill called Trazivir accounted for 64% of Glaxo’s HIV sales in 2003.

Glaxo applied for approval of Epzicom in October and Gilead submitted its Truvada application in March, the FDA said.