DURHAM, N.C., Jan. 17, 2002 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) today provided updated
information on the development of two of its HIV compounds, Coviracil and
Coactinon.
Following recent discussions with the FDA, Triangle now plans to submit a
New Drug Application (NDA) early this fall for Coviracil in the treatment of
HIV. The Company expects Coviracil to become its first product for which an
NDA is submitted, marking a critical milestone in the Company's history.
Triangle further intends to terminate development of Coactinon, another of
its HIV compounds. The Company recently completed a planned interim analysis
of 24-week data from study MKC-401. Although the results of this interim
analysis did not trigger the pre-defined criteria for stopping the study, the
interim analysis indicated that Coactinon was not performing as well as its
comparator drug, abacavir, across the full study population. Therefore,
Triangle has elected to discontinue development of Coactinon and allocate the
Company's personnel and other resources to more promising drug candidates
within its portfolio. Those drug candidates include: (1) Coviracil, for which
a 3rd quarter NDA submission is planned for the treatment of HIV disease and a
pivotal trial is ongoing in the treatment of hepatitis B infection; (2)
amdoxovir (DAPD), for which the Company plans to initiate several Phase II
trials in HIV during 2002; and (3) clevudine (L-FMAU), which is currently in
an ongoing Phase I/II study in the treatment of hepatitis-B infection and for
which a Phase II program is planned to be commenced during 2002. Triangle
will provide a full update on these programs and the Company's 2002 financial
and operating plans in conjunction with its earnings release scheduled for
early February 2002.
"We are very pleased to be in a position to submit the Coviracil NDA in
the third quarter of this year," stated Dr. David Barry, Chairman and CEO of
Triangle. Dr. Barry continued, "With the expected Coviracil NDA submission
now only two quarters away, we must prioritize our efforts and resources to
ensure that this timeline is met, and to advance the most promising programs
in our pipeline as aggressively as possible."
Triangle stands to receive potential reimbursement milestones from Abbott
Laboratories of up to $85 million upon obtaining regulatory approval and the
launch of Coviracil for the treatment of HIV in the U.S. and Europe. In
addition, despite the termination of the Coactinon program, Triangle stands to
receive additional potential reimbursement milestones of up to $35 million
upon obtaining regulatory approvals of amdoxovir and clevudine in the U.S.
Under a 1999 agreement, Triangle and Abbott have joint rights to commercialize
Coviracil, amdoxovir, and clevudine in the U.S. Outside the U.S., Abbott will
have exclusive commercialization rights for these drug candidates.
The Company will hold a conference call on Friday, January 18, 2002 at
11:30 a.m. EST. Interested parties in the U.S. may join the call by dialing
toll free 877-679-9055. International callers may dial 952-556-2808. The
confirmation number is 5788516 and the moderator is Dr. David Barry. The call
will be Webcast on the Triangle Pharmaceuticals Web site at http://www.tripharm.com
and archived for replay on the site for one week after the call.
Triangle Pharmaceuticals is engaged in the development of new antiviral
drug candidates, with a particular focus on therapies for the human
immunodeficiency virus (HIV) and hepatitis. Triangle's proprietary drug
candidates under development for HIV and/or hepatitis include Coviracil(R)
(emtricitabine), amdoxovir and clevudine. Triangle is also developing
immunotherapies for HIV and hepatitis in collaboration with Dynavax Technology
Corporation utilizing Dynavax' ImmunoStimulatory Sequence (ISS) technology.
More information about Triangle's portfolio, management and product
development strategy is available on Triangle's website at: http://www.tripharm.com.
Statements in this press release that are not historical facts are
forward-looking statements and are subject to numerous risks and
uncertainties, including the fact that clinical trials for our drug candidates
may not proceed as planned and regulatory submissions for our drug candidates
may be delayed. Additionally, other risks include the fact that the Company
may be unable to successfully complete pivotal clinical trials or that its
trials could be halted or terminated by regulatory authorities, the Company
may be unable to commercialize Coviracil, DAPD and ISS-based therapies due to
patent rights held by third parties, that cash usage targets may not be met
for a number of reasons, including the risk that changes in our drug
development strategies or unpredictable events may impact the timing and
degree of actual spending, the Company's ability to obtain additional funding
(including contingent contractual milestone payments), patent protection and
required regulatory approvals for its drug candidates, the development of
competitive products by others, the cost of coactive therapy and the extent to
which coactive therapy achieves market acceptance, the Company's success in
identifying new drug candidates, acquiring rights to the candidates on
favorable terms and developing any candidates to which the Company acquires
any rights, and that the Company's collaborations with third parties may not
prove successful. These and other risks are discussed in detail from time to
time in the Company's 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. The Company 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:
Mr. Robert Amundsen, Executive Vice
President, Chief Financial Officer, +1-919-493-5980, or Mr. Chris
Rallis, President, Chief Operating Officer, +1-919-493-5980, both
of Triangle Pharmaceuticals, Inc.
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