New York Firm Is a Step Closer to Selling AZT

A New York company has won conditional approval to market the AIDS-fighting drug AZT if Burroughs Wellcome Corp. loses its monopoly on the medication.

The National Institutes of Health granted the conditional marketing license to Barr Laboratories Inc. of Pomona, N.Y., NIH spokesman Marc Stern said Wednesday.

Under the agreement, Barr would be allowed to sell AZT if the company prevailed in a lawsuit challenging Burroughs Wellcome’s patents and obtained Food and Drug Administration approval to make a generic version of the drug.

AZT is the only approved therapy that attacks the AIDS virus directly, slowing progression of the disease. It is for those who have AIDS or are infected with the human immunodeficiency virus that causes the disease.

Burroughs Wellcome is the only U.S. source of the drug, which costs about $3,000 a year. Barr spokesman Harold Cohen said the company hopes to sell the drug for about 40% less, making it available to far more AIDS patients.

Burroughs Wellcome denounced the NIH-Barr agreement as “an unwise intrusion by government” into a pending suit between the drug companies.

“Burroughs Wellcome is confident that its patent rights will be upheld,” the company said in a statement. “The NIH has no rights in these patents and therefore it has nothing which can be licensed or sold to Barr.”

Even if Barr won its patent suit and got FDA approval to make the drug, it could not market AZT until next March, when Burroughs Wellcome’s rights to sell it as a so-called orphan drug expire, Cohen said.