DURHAM, N.C., Nov. 4, 2002 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) announced today that the
U.S. Food and Drug Administration (FDA) has notified the Company that its New
Drug Application (NDA) for marketing approval of Coviracil for the treatment
of HIV disease has been accepted for filing. Filing of the NDA is recognition
by the FDA that the application is sufficiently complete for review.
"We are very pleased with this notification," commented Daniel G. Welch,
Chairman and Chief Executive Officer of Triangle. He continued, "Consistent
with our previous guidance when we submitted our NDA, the FDA granted
Coviracil a standard review. This means that as early as the third quarter of
2003, we hope to have our first NDA approved. We believe, once approved,
Coviracil will offer patients and physicians an important new medicine for the
management of HIV disease. We will now turn our efforts to completion of the
review process with the FDA to work towards the timely approval of Coviracil."
Coviracil is a potent, once-a-day Nucleoside Reverse Transcriptase
Inhibitor (NRTI). The NDA includes data from over 2,000 patients and is
supported by two pivotal trials, FTC-303 and FTC-301. Triangle expects to
file a European Marketing Authorisation Application (MAA) by December 31,
2002.
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(R) (emtricitabine), amdoxovir
(formerly DAPD), and clevudine (formerly L-FMAU). Triangle is also developing
immunotherapies for hepatitis B in collaboration with Dynavax Technologies
Corporation (Dynavax) utilizing Dynavax' immunostimulatory sequence (ISS)
technology. 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 we may not submit our Coviracil MAA as
planned and our Coviracil NDA or MAA may not receive regulatory approval, or
if approved, Coviracil may not achieve market acceptance or the medical
results we expect. 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: Daniel G. Welch, Chairman and Chief Executive Officer, or Robert F. Amundsen, Jr., Executive Vice President and Chief Financial Officer, +1-919-493-5980 both of Triangle Pharmaceuticals, Inc.
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