Newport Pharmaceuticals International Inc., whose drug Isoprinosine was rejected last month by the Food and Drug Administration as a treatment for AIDS, said Monday that despite a slight improvement in third-quarter earnings, it posted losses for the nine months ended Jan. 31.
The controversial Newport Beach-based drug maker said net earnings for the quarter increased 15% to $116,000 from $101,000 a year earlier. Revenues for the quarter totaled $3.1 million, up 14% from $2.7 million in 1985.
During the first nine months of the year, the company said, European sales were soft due to an oversupply of Isoprinosine, but the shortfall was partially offset by a $324,000 increase in sales in Mexico, where the drug is approved for treating herpes simplex, company spokeswoman Launa Kruse said.
The decrease in nine-month sales, coupled with increased sales and research costs, Kruse said, resulted in a net loss of $377,000 for the period compared to net earnings of $568,000 a year ago. Nine-month revenues dipped to $7.6 million from $8 million last year.
Loss for Year Predicted
Newport's third-quarter and nine-month results were "pretty much as expected," said Scott King, an analyst with Montgomery Securities Inc., of San Francisco. The company, he said, will likely post a loss for the year.
Newport, however, declined to make any projections.
Although Newport has been in business for more than 16 years, Isoprinosine is its only product. While the drug has been approved for treatment of a variety of ailments overseas, including herpes simplex, it has never been approved for general use in the United States.
On Feb. 21, the FDA rejected Isoprinosine for acquired immune deficiency syndrome use and rebuked Newport for misrepresenting results of tests which the FDA said utilized too few patients to gather any "meaningful evidence" of the drug's effectiveness.
However, Newport plans to submit new clinical test data on Isoprinosine to the FDA "within a matter of a couple of months," company spokeswoman Kruse said. "We're hopeful that it will be approved. We believe that we can address the deficiencies and go on from there."
Under FDA rules, the company may file a new application for approval, and the federal agency can take up to 180 days from the time of the filing to make a decision, said FDA spokeswoman Susan Cruzan.
So far, New Zealand is the only country to permit use of Isoprinosine specifically for AIDS. No applications for its use against the disease are pending elsewhere, Kruse said.