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AZT Maker Announces New Drug to Fight Aids-Related Affliction With AM-Condoms-Kids, Bjt

November 13, 1991

RESEARCH TRIANGLE PARK, N.C. (AP) _ The maker of the AIDS-fighting medication AZT on Tuesday announced the development of an experimental drug to combat pneumonia, a leading cause of death among patients afflicted with AIDS.

Burroughs Wellcome Co. said the Food and Drug Administration has authorized wider use of the drug, now called 566, through physicians for the treatment of Pneumocystis carinii pneumonia (PCP) in people with AIDS.

The company said the medicine should be available to the general public for prescription use by 1992. Physicians currently can obtain it for their patients for test purposes.

PCP, an infection that usually remains dormant in the lungs but becomes active when the immune system weakens, affects more than 80 percent of people with acquired immune deficiency syndrome during the course of the disease, doctors said.

The company said there was no correlation between the timing of its announcement and the revelation last week that basketball star Magic Johnson had tested positive for the AIDS virus.

″None whatsoever,″ said Burroughs Wellcome spokesman Thack Brown. ″This has been under study for a long time.″

Still, the announcement seemed to reflect a heightened sensitivity by the drug industry toward publicizing progress in treating AIDS, which captured renewed attention after Johnson’s revelation.

For example, Belmac Corp., a pharmaceutical company in Tampa, Fla., said Tuesday it plans to seek federal approval this spring to test a new antibiotic, called Azaquinone, to battle AIDS-related tuberculosis and other illnesses common to AIDS sufferers.

Burroughs Wellcome said about 400 patients have received 566 at 39 sites throughout the United States, Canada and Europe. They expect thousands to apply for the free, orally ingested drug in the month or so before awaiting approval for marketing by the FDA.

″Nobody has an idea what the need will be,″ said Dr. Judith Falloon of the National Institute of Health in Bethesda, Md. ″I think the need being in the thousands is not unrealistic.″

Patients intolerant or unresponsive to other drugs, including trimethoprim and sulfamethoxazole, are eligible to receive the new test drug, company officials said.

″I do think it is an advancement in terms of quality of life and for some people it can have an impact on survival,″ Ms. Falloon said. ″We have been needing other therapies for PCP and this fits a part of that bill.″

Company officials expressed optimism that the drug would hit the market by yearend.

″Traditionally, FDA insisted that every ‘I’ be dotted and every ‘T’ be crossed about the safety of the drug before it was approved,″ Brown said. ″But with the coming of diseases like AIDS, where people don’t have the time to wait for all that, there has been a change in thinking.″

Brown conceded the drug may be rushed to market before it’s perfected: ″If there is some evidence that it does some good it is better to give it to people who have no hope than to allow those people to die while you do all the detailed studies.″

Brown declined to say how much the drug would cost if approved by the FDA.

″At this point 566 is the project number at Burroughs Wellcome. It doesn’t have a name, let alone a price,″ Brown said.

Stephen LaFon, a spokesman for the company’s infectious disease department, said 566′s unique feature is it kills the parasite that causes PCP, as opposed to other drugs which prevent it from growing.

Brown said the company has established a toll-free number where physicians and patients can call requesting 566.

″It’s not approved for marketing,″ Brown said. ″We can’t go out and sell the product. But what we can do is make it available to people who don’t have any other options to use in attempting to control the disease.″

Burroughs Wellcome is best known for the development of Retrovir brand zidovudine (AZT) in 1986, the first antiretrovial drug for use in adults and children with the human immunodeficiency virus.

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EDITOR’S NOTE - Physicians interested in enrolling a patient in the 566 treatment program should call 1-800-755-2020.

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