Agouron Pharmaceuticals Inc. Thursday confirmed that it would filea New Drug Application (NDA) during the first quarter of 1997based on positive preliminary results of pivotal clinical trials testingthe HIV protease inhibitor Viracept. It will be the company's firstproduct to face the regulatory approval process.
Agouron's stock (NASDAQ:AGPH) gained $4.50 on the news toclose Thursday at $54.25.
"This announcement simply shows that we are on schedule withViracept," said Donna Nichols, senior director of corporatecommunications for the La Jolla, Calif. company.
In July, Agouron made the decision to complete a stock offeringdespite a slump in the market in order to raise funds to keep itsViracept development on track. The company raised $75 million inthe sale of 2.5 million shares but sold the stock for 25 percent lessthan it was trading at when the company registered for the offering.
Thursday's news vindicated that decision. Kevin Tang, an analystwith Alex. Brown & Sons in New York, noted that for Agouron"filing an NDA means everything."
Agouron did not release the results of the three pivotal clinical trials,but said the data will be presented either at scientific meetings or anopen meeting with the FDA. The trials test two different doses of thedrug as a monotherapy, in combination with d4T and in combinationwith nucleoside analogues AZT and 3TC.
"While we are not prepared to discuss the specifics of the clinicaltrials, it remains our strong impression that Viracept is safe and well-tolerated," said Nichols. "The preliminary results are veryencouraging and in general the pilot trials do not appear to havemisled us."
Should it be approved by the FDA, Viracept will join three otherprotease inhibitors that already are on the market. However, Nicholsnoted that the drug's safety profile, dosing schedule and resistanceprofile could make Viracept the protease inhibitor of choice. "Theonly side effect that we found with Viracept was a mild to moderatediarrhea, and patients don't have any dosing limitations," Nicholssaid.
However, even more important with a quickly mutating virus likeHIV, when the virus becomes resistant to Viracept, it still issusceptible to all the other protease inhibitors on the market.
"That is in stark contrast Merck & Co.'s protease inhibitor," Nicholssaid. "When [the virus] becomes resistant to that protease inhibitor, itis resistant to all of them. This would make it likely that Viraceptwould be the first protease inhibitor of choice." n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.