Agouron's Viracept Receives Marketing Approval in Canada
PR Newswire, Wednesday, August 12, 1998 at 08:22
LA JOLLA, Calif., Aug. 12 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(NASDAQ:AGPH) today announced the Therapeutic Products Directorate of the
Canadian Health Protection Branch (HPB) has issued a Notice of Compliance for
the company's HIV protease inhibitor, VIRACEPT(R) (nelfinavir mesylate). The
Notice of Compliance allows Agouron to market VIRACEPT in Canada for the
treatment of HIV infection in combination with reverse transcriptase
inhibitors. This indication is based on analyses of surrogate endpoints in
clinical studies of up to 48 weeks. VIRACEPT is the first protease inhibitor
to receive simultaneous approval of an indication for both adults and children
in Canada.
VIRACEPT has been available in Canada without charge since May 1997 to
more than 1200 qualified adults with advanced HIV disease through the largest
Canadian protease inhibitor expanded access program. HIV-infected children
aged two to twelve years with no alternatives have received the drug through
the Special Access Program (previously referred to as the Emergency Drug
Release Program).
VIRACEPT has been evaluated in clinical trials involving more than 8000
people throughout the world and is now approved for marketing in more than 30
countries worldwide. More than 120,000 people are estimated to be taking
VIRACEPT.
The most commonly observed adverse event of moderate or greater severity
in clinical trials of VIRACEPT was diarrhea, which was generally controlled
with over-the-counter medications. New onset or exacerbation of diabetes
mellitus and hyperglycemia, as well as increased bleeding in patients with
hemophilia types A and B, have been reported with protease inhibitors.
Agouron Pharmaceuticals Canada Inc. established headquarters in
Mississauga, Ontario in March 1998 and will market VIRACEPT in Canada.
Agouron Pharmaceuticals Canada Inc. has established a patient assistance
program to actively help people find drug reimbursement options.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical company
committed to the discovery, development, manufacturing, and marketing of
innovative therapeutic products engineered to inactivate proteins that play
key roles in cancer, AIDS, and other serious diseases.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please see Agouron's website at agouron.com. To receive
full prescribing information for VIRACEPT via fax, dial US number
1-888-288-9639.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
-0- 08/12/98
/CONTACT: Investors: Donna Nichols, Vice President, Head of Corporate
Communications, 619-622-3009, or Media: Joy Schmitt, Associate Director,
Product Public Relations, 619-622-3220, both of Agouron Pharmaceuticals, Inc./
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 019650/
/Web site: agouron.com |
