FDA Clears Agouron to Market VIRACEPT - A New HIV Protease Inhibitor for
Adults and Children
PR Newswire - March 14, 1997 12:59
FINANCIAL AGPH MTC V%PRN P%PRN
Jump to first matched term
VIRACEPT to be Available to Patients Within Days
LA JOLLA, Calif., March 14 /PRNewswire/ -- The Food and Drug
Administration (FDA) has given Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) clearance to market the company's HIV protease inhibitor
VIRACEPT(R) (nelfinavir mesylate) in the United States, under the provisions
of the FDA's accelerated approval process. VIRACEPT is the first HIV protease
inhibitor to be cleared for marketing simultaneously in an adult formulation
and in a pediatric formulation. Agouron reported that VIRACEPT will be widely
available at pharmacies throughout the United States next week.
"Today's approval of VIRACEPT is important for the field of HIV disease,"
said Dr. William Powderly, Washington University School of Medicine, St.
Louis. "The anti-HIV potency of VIRACEPT, coupled with its favorable safety
and tolerability will make a valuable contribution to our ability to hit the
virus hard and early with combination therapy."
VIRACEPT is indicated for the treatment of HIV infection when
antiretroviral therapy is warranted. This indication is based on analyses of
surrogate marker changes in patients who received VIRACEPT in combination with
nucleoside analogues or alone for up to 24 weeks. At present, there are no
results from controlled trials evaluating the effect of therapy with VIRACEPT
on clinical progression of HIV infection, such as survival or the incidence of
opportunistic infections.
The Wholesale Acquisition Cost of VIRACEPT will be $15.48 per day or $5650
for a 365-day supply at the recommended dose of 750 mg three times daily
(TID). To facilitate patients' access to VIRACEPT, Agouron has established a
patient assistance program to actively help people to find ways of paying for
VIRACEPT. Agouron will provide VIRACEPT without charge to those patients
whose need is greatest and who are least able to pay for the drug. In
addition, Agouron will provide VIRACEPT without charge to any child in the
United States who is not covered by public or private health insurance. For
information on the VIRACEPT Assistance Program for both adults and children,
call toll free 1-888-777-6637.
Agouron will make VIRACEPT available to all AIDS Drug Assistant Programs
(ADAPs), including those that purchase products through government-discounted
pricing and will offer rebates to any ADAP that is unable to purchase products
at the government-discounted rates. In addition, Agouron will make VIRACEPT
available to Medicaid. For product information, call Agouron Customer
Communications toll free at 1-888-847-2237.
VIRACEPT has been evaluated in clinical trials involving more than 1000
people to date and has been made available without charge to an additional
3000 patients through the VIRACEPT Expanded Access Program. Expanded access
programs represent an effort by FDA to make investigational drugs available at
the earliest opportunity to people for whom no other comparable or
satisfactory therapy exists. In clinical studies of VIRACEPT, the most
commonly observed adverse event of moderate or greater severity was diarrhea
which was generally controlled with over-the-counter medications.
Results from pivotal phase II/III trials of VIRACEPT were presented in
January, 1997 by several investigators at the 4th Conference on Retroviruses
and Opportunistic Infections in Washington D.C. In these presentations,
calculated reductions of HIV in plasma (viral load) were based upon a branched
DNA amplification (bDNA) assay incorporating measurements of HIV to lower
limits of either 500 or 100 copies per ml. In reviewing data related to the
VIRACEPT NDA, the FDA determined that values below 1200 copies per ml could
not be reliably quantified by the bDNA assay and required that calculated
reductions in viral load be based upon a lower limit of 1200 copies per ml in
the VIRACEPT package insert. In the key clinical study, the recommended dose
of 750 mg VIRACEPT TID taken in combination with AZT plus 3TC produced a mean
reduction in viral load after six months of 98% (1.7 log10) using a lower
limit of 1200 copies per ml. In January, this six-month value was reported as
99% (2.0 log10) and >99% (2.5 log10) based upon lower limits of 500 and 100
copies per ml, respectively.
"All of us at Agouron are deeply gratified that VIRACEPT has been cleared
by FDA under the accelerated review process," said Peter Johnson, Agouron
president and chief executive officer. "We are confident that the safety,
tolerability and anti-HIV potency of VIRACEPT will earn it a prominent role in
contemporary therapy."
VIRACEPT has been developed by Agouron in collaboration with the
pharmaceutical division of Japan Tobacco Inc.
Agouron Pharmaceuticals, Inc. discovers, develops, manufactures and
markets novel, small molecule drugs engineered to inactivate proteins which
play key roles in cancer, AIDS, and other serious diseases.
NOTE: VIRACEPT is a registered trademark of Agouron Pharmaceuticals.
SOURCE Agouron Pharmaceuticals Inc.
CONTACT: Investor Contact: Donna Nichols, Senior Director, Corporate
Communications, 619-622-3009, or Media Contact: Joy Schmitt, Manager, Product
Public Relations, 619-622-3220, both of Agouron, or website:
agouron.com |
