Old news that has very important near term influence. This press release is OLD OLD OLD (I dont want to be accused of intentionally vague misrepresentations), but needs to be reviewed at this time. I wonder which little punk will attack me for this one.
Agouron Files European New Drug Application for Anti-HIV Drug VIRACEPT
LA JOLLA, Calif., February 19, 1997 Agouron Pharmaceuticals, Inc. (NASDAQ NM: AGPH) today announced its European subsidiary has submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the anti-HIV drug VIRACEPTr (nelfinavir mesylate). In submitting the MAA, Agouron Pharmaceuticals (Europe) Limited seeks approval in most major European countries of both tablet and pediatric oral powder formulations of VIRACEPT based principally on results from three pivotal phase II/III clinical trials evaluating the safety and efficacy of the drug in more than 700 HIV-infected subjects. Action by the EMEA on the VIRACEPT MAA is expected by Agouron later in calendar 1997.
VIRACEPT, an inhibitor of HIV protease, is being developed by Agouron in collaboration with the pharmaceutical division of Japan Tobacco Inc. (JT). A New Drug Application (NDA) for VIRACEPT was filed in the United States on December 23, 1996. F. Hoffmann-La Roche Ltd was granted marketing rights for VIRACEPT in Europe and certain other markets by Agouron and JT last month.
The VIRACEPT MAA was produced with a state-of-the-art regulatory publishing system, Core Dossier, from ESPS Inc.
Agouron Pharmaceuticals, Inc. is a pioneer and leader in technologies permitting the rational design of novel, small molecule drugs based upon the molecular structures of proteins which play key roles in human disease. Agouron is currently applying these technologies to the design and development of novel drugs for treatment of cancer, AIDS, and other serious diseases. |
