Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Thursday, 24 October 1996.
Since February 1996, VIRACEPT has been the subject of three clinical trials involving a total of more than 700 subjects. Two alternative doses of VIRACEPT have been administered as monotherapy or in combination either with d4T or with the two-drug combination of AZT plus 3TC. Primary efficacy endpoints in the trials are decreases in plasma HIV RNA ("viral load") and increases in CD4+ T cells. Agouron's decision to submit an NDA for VIRACEPT was based upon an analysis of results from the first four months of treatment in these six-month studies. Results from these clinical trials will be made public in detail within the next few months, either at a scientific meeting or at a public FDA meeting.
"We are obliged to disclose our decision to proceed with preparing and filing the VIRACEPT NDA because of the materially important role of this decision in the affairs of Agouron," said Peter Johnson, Agouron's president and chief executive officer. "Strongly encouraged by the preliminary results from pivotal trials, we will now undertake a number of pre-launch activities which assume the timely submission and approval of a VIRACEPT NDA. However, we are anxious to remind all those interested in VIRACEPT that there can be no assurance that any such approval from FDA will be forthcoming."
VIRACEPT is being developed by Agouron in collaboration with the pharmaceutical division of Japan Tobacco Inc. (JT). JT, a diversified company with annual revenues in excess of $30 billion and assets exceeding $18 billion, entered the pharmaceutical business in 1987. In the field of ethical pharmaceuticals, JT is currently engaged in clinical development of various drugs, including those for the treatment of dimentia, asthma, and angina pectoris, and has launched a 5HT3 antagonist as an anti-emetic in Japan in 1994. JT presently conducts drug discovery research at its new Central Pharmaceutical Research Institute in Osaka, Japan.
Agouron Pharmaceuticals, Inc. is a pioneer and leader in the development and application of technologies that enable the atom by atom design of novel synthetic drugs based upon the molecular structures of target 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.
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