New Zealand OKs Drug for Use on AIDS

In what may represent a breakthrough for a Newport Beach drug company in its quest for federal approval of a drug for use against AIDS, Newport Pharmaceuticals International Inc. said Thursday that the drug Isoprinosine has received approval in New Zealand for treating the dread disease.

New Zealand is the first government to approve any drug specifically for AIDS-related diseases.

Newport Pharmaceuticals will sell the drug to Douglas Pharmaceuticals Ltd. of Auckland in bulk form. Douglas will process it into tablets and syrup for sale, said Alvin J. Glasky, Newport Pharmaceuticals’ president. Shipments of the drug are expected to begin in January.

There are fewer than two dozen AIDS sufferers in New Zealand, said Luana Kruse, a spokeswoman for Newport Pharmaceuticals. However, an additional 60 people have AIDS-related complex, a malady in which victims suffer some AIDS symptoms without showing evidence of having the full disease, and “we have seen hundreds who have been diagnosed as possibly having the AIDS virus,” she said. “Although the market is small, it can grow.”

In September, Newport Pharmaceuticals filed for U.S. Food and Drug Administration approval to market the drug in the United States for AIDS treatment.

Some industry analysts think the drug’s approval in New Zealand may spur the FDA to endorse it as well.

Still, though it is marketed in 88 countries for treatment of a variety of diseases ranging from herpes simplex types I and II to measles, Isoprinosine is not approved for any use in the United States.

Developed in the late 1960s, Isoprinosine was originally intended to treat memory loss in senior citizens.

In May the FDA began allowing the company to make Isoprinosine available to AIDS victims on a regulated “compassionate care” basis.

“There are about a dozen or so drugs that currently are in clinical testing . . . but only two have applied for new drug approval,” said Brad Stone, an FDA spoksman, who added that possible FDA approval of Isoprinosine “is in the process, but there is no definite time frame for it.”