WASHINGTON -- In a move that could significantly reduce the cost of AZT, the only approved AIDS drug, the National Institutes of Health said yesterday that it had helped Burroughs Wellcome Co. develop the patented medication and wants authority to license other companies to market it.
NIH Director Bernadine Healy said in a statement that the National Cancer Institute, one of the NIH's constituent research agencies, should have been named a co-inventor of the anti-viral drug and that Burroughs' monopoly on the drug should be broken.
Dr. Healy said that the NIH may grant a non-exclusive marketing license requested by Barr Laboratories, another private company, if Barr prevails in a pending legal challenge of the Burroughs patent.
"NIH is contemplating the granting of this license so that the company legally would be able to market AZT if it is ultimately determined, in litigation between Barr and Burroughs Wellcome, that the government is entitled to inventorship status," Dr. Healy said. "In that event, competition would result in a lower price for AZT."
The cost of AZT has been an issue since the Food and Drug Administration approved it in 1987 as the first drug to treat the underlying viral condition that causes AIDS. When the drug was introduced, it cost the average AIDS patient from $8,000 to $12,000 a year.
Under pressure from AIDS activists, members of Congress and others, Burroughs twice lowered the price of the drug. The cost of AZT therapy was further reduced when studies demonstrated that lower dosages were just as effective as the higher-level ones in earlier studies. AZT currently costs a typical patient about $3,000 a year.
Some experts believe that the cost of the drug could be reduced by one-half to two-thirds if other manufacturers were allowed to market AZT.
Dr. Healy said that her agency and the drug company did not disagree about the substance of their scientific contributions to the development of the drug, also known as zidovudine, but that they differed over the patent law consequences.
Burroughs Wellcome and the government were named in March as co-defendants in a lawsuit filed by Public Citizen, a public interest group representing the People with AIDS Health Group and several AIDS patients who challenged the validity of the patent.
Burroughs and the government have filed a motion to dismiss the case.
Burroughs has acknowledged collaborating with the NCI in development of the drug, but the company, based in Research Triangle Park, N.C., maintains that its scientists were the first to think of using AZT as an AIDS therapy.
Barr, a Pomona, N.Y., drug maker, is seeking FDA approval to market AZT as a therapy for individuals who are infected with the human immunodeficiency virus but have not yet developed symptoms of the acquired immune deficiency syndrome.