- The Washington Times - Monday, December 20, 2004

TRENTON, N.J. (AP) — Two drug companies announced yesterday they will collaborate on developing the first all-in-one, once-a-day pill to treat HIV infection — a long-sought goal that would make it much easier for patients to stick with taking their medication.

Currently, the best HIV treatment requires patients to take two to four pills a day. Less than a decade ago, many patients had to take 25 to 30 pills a day, often at precise times and under specific conditions, such as with food, making it extremely difficult for patients to stick to the complex schedule. Missing doses makes it easier for the virus to mutate and become resistant to medication.

In the first collaboration by competing HIV drug makers, Bristol-Myers Squibb Co. and Gilead Sciences Inc. formed a joint venture to test and market a single pill combining three widely used medicines from two different classes of HIVdrugs.

Because the three individual drugs already are on the market, the once-a-day combination could be approved and on sale as soon as the second half of 2006, said David Rosen, a spokesman for Bristol-Myers Squibb.

“To have it all in a single pill is terrific,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The combination pill will include Sustiva, made by Bristol-Myers Squibb, which is based in New York and has research headquarters in Princeton, N.J. The pill also will include two HIV drugs made by Gilead Sciences of Foster City, Calif.: Viread and Emtriva.

The latter two drugs are from the same class of HIV drugs, but they block copying of HIV at two different points early in its replication cycle. Sustiva is from a different class of drugs and attacks the virus later in the cycle.

“It’s the first time ever that two companies with competing products have worked together,” said Dr. Michael Saag, director of the Center for AIDS Research at the University of Alabama at Birmingham. “This is something patient advocates and a lot of physicians have been pushing for over a decade.”

Dr. Fauci also said such partnerships are crucial.

“We hope it’s the beginning of future collaborations,” he said.

The three drugs in the combination, which are becoming the treatment of choice, together now cost $900 to $1,000 a month, said Dr. Saag, who has consulted for both companies and many rival drug makers.

It was too soon to discuss how much the companies will charge for the single pill, Mr. Rosen said.

The combination does not include a protease inhibitor, a class of drug that has been standard in recent years but that also produces many side effects.

The once-a-day pill will benefit patients in this country and, eventually, in the developing world, where simple treatments desperately are needed, Dr. Saag said.

Bristol-Myers and Gilead are first seeking approval to sell the drug in this country, then will pursue approval in some Western European countries and Canada, where Bristol-Myers also has rights to sell Sustiva.

Merck & Co., of Whitehouse Station, N.J., has rights to sell that drug in other countries but markets it under the name Stocrin.



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