DURHAM, N.C., Jan. 6, 2003 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) announced today that the
Marketing Authorisation Application (MAA) for emtricitabine for the treatment
of HIV infection was submitted to the European Agency for the Evaluation of
Medicinal Products (EMEA) and that the EMEA has accepted the application for
review. Triangle previously submitted a New Drug Application (NDA) for
emtricitabine for the treatment of HIV infection to the U.S. Food and Drug
Administration (FDA) which was accepted for review on November 1, 2002.
Emtricitabine is a once-a-day nucleoside reverse transcriptase inhibitor
(NRTI). The tradename for emtricitabine in Europe is under review. In the
United States and other countries, emtricitabine will be marketed under the
Coviracil(R) tradename.
"We are very pleased to have delivered on our earlier commitment to
complete the European filing around the end of 2002," commented Daniel G.
Welch, Chairman and Chief Executive Officer of Triangle. He continued, "We
believe, pending marketing clearance, emtricitabine may offer patients and
physicians in Europe an important new medicine for the management of HIV
disease."
The MAA includes data from over 2,000 patients and is supported by two
pivotal trials, FTC-303 and FTC-301. The MAA will be reviewed under the
centralized licensing procedure, which, if approval is granted, provides a
marketing license valid in all member states of the European Community.
On December 4, 2002, Gilead Sciences, Inc. (Nasdaq: GILD) and Triangle
announced that they signed a definitive agreement under which Gilead plans to
acquire Triangle. The transaction has been structured as a two-step
acquisition comprised of a cash tender offer for all of the outstanding
Triangle common stock at $6.00 per share, followed by a cash merger in which
Gilead would acquire any remaining outstanding Triangle common stock at $6.00
per share. The transaction is expected to close in the first quarter of this
year, subject to customary closing conditions.
Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the development of new antiviral drug candidates, with a particular
focus on therapies for the human immunodeficiency virus (HIV) and the
hepatitis B virus. Triangle's proprietary drug candidates under development
for HIV and/or hepatitis B include Coviracil (emtricitabine), amdoxovir
(formerly DAPD), and clevudine (formerly L-FMAU). More information about
Triangle's portfolio, management and product development strategy is available
on Triangle's website.
Statements in this press release that are not historical facts are
forward-looking statements and are subject to numerous risks and
uncertainties, including the risk that our NDA or MAA may not receive
regulatory approval, or if approved, may not achieve market acceptance or the
medical results we expect. In addition, the ability of Gilead and Triangle
to close the transaction by the end of the first quarter of 2003 will depend
on a number of factors outside the parties' control including the satisfaction
of closing conditions. These and other risks are discussed in detail from
time to time in our filings with the Securities and Exchange Commission. As a
result of these and other risks and uncertainties, actual results may differ
materially from those predicted in this press release. Triangle disclaims any
obligations to update any forward-looking statements in this press release.
SOURCE Triangle Pharmaceuticals, Inc.
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Related links:
http://www.tripharm.com
CONTACT:
Andrew Finkle, Executive Vice President &
General Counsel, +1-919-493-5980 , or Thomas R. Staab, II,
Vice President & Treasurer, +1-919-493-5980, both of Triangle
Pharmaceuticals, Inc.
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