LA JOLLA, Calif., Dec. 23 /PRNewswire/ -- Agouron Pharmaceuticals Inc today announced it has submitted to the U.S. Food and Drug Administration
(FDA) a New Drug Application (NDA) covering its anti-HIV drug VIRACEPT(R) (nelfinavir mesylate). Agouron is the first company to petition FDA for
simultaneous approval of its HIV protease inhibitor for adults and for children.
The NDA seeks accelerated approval 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. These pivotal studies evaluated daily doses
of 1500 or 2250 mg of VIRACEPT taken alone, in combination with the approved drug Zerit(TM) (d4T), or in combination with the approved drugs
Retrovir(R) (AZT) and Epivir(TM) (3TC). Primary endpoints followed in these six-month clinical trials in adults were improvements in two surrogate
markers for efficacy: decreases in HIV RNA in plasma and increases in CD4+ T cells in plasma. The NDA also included results from a small clinical study
showing that appropriate blood levels of VIRACEPT can be achieved safely in children.
"The submission of the NDA for Agouron's first commercial product, VIRACEPT, is an event of great significance for our company and, we believe, for
the field of HIV disease," said Peter Johnson, Agouron's president and chief executive officer. "That we have been able to reach this point just three years
after first synthesizing the drug in our laboratories is a credit to the relentless devotion and effort of more than 100 Agouron employees on the VIRACEPT
development team; of our partners and colleagues in the pharmaceutical group at Japan Tobacco Inc.; and of the staff and management of PAREXEL
International Corporation, a leading contract research organization, who, with uncommon dedication, anchored the processes of data management and
analysis. It is also testimony to a spirit of proactive cooperation in drug development now present at FDA."
VIRACEPT is a synthetic chemical compound designed to inhibit HIV protease-an enzyme that plays an essential role in the replication of HIV. VIRACEPT
is being developed by Agouron in collaboration with the pharmaceutical division of Japan Tobacco 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. SOURCE Agouron Pharmaceuticals, Inc. |
