President Describes Settlement as 'Important Step'
DURHAM, N.C., June 10 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) today announced the final
settlement among Emory University (Emory), GlaxoSmithKline and Shire
Pharmaceuticals Group plc (Shire) of longstanding patent disputes involving
lamivudine and Triangle's drug candidate Coviracil (emtricitabine), a
nucleoside reverse transcriptase inhibitor in Phase III development for the
treatment of HIV and hepatitis B. Triangle plans to submit a New Drug
Application for Coviracil for the treatment of HIV to the FDA in the third
quarter of this year.
Chris A. Rallis, President of Triangle, commented, "We are very pleased
that the parties have been able to finalize this settlement. We particularly
want to thank Emory University for its efforts in resolving this dispute.
Obviously, our objective is to maximize the potential commercial value of
Coviracil, and this settlement is an important step in that process. The
settlement allows us to eliminate future legal costs and other patent-related
uncertainties associated with this dispute. We can now continue to focus our
efforts on the planned third quarter submission of an NDA for Coviracil."
Under the terms of the settlement, Emory receives an exclusive license
from Shire under Shire's patents relating to Coviracil and Shire and
GlaxoSmithKline receive exclusive licenses under Emory's patents relating to
lamivudine.
Triangle holds the worldwide rights to Coviracil under an exclusive
license agreement with Emory and, under the terms of this license agreement,
automatically acquires an exclusive sublicense to the Shire patents relating
to Coviracil granted under the terms of the settlement to Emory. Triangle's
milestone and royalty obligations relating to Coviracil under its license
agreement with Emory will not be affected.
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 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 patents may not adequately protect the
technology we own or license. Additionally, other risks include the fact that
clinical trials for our drug candidates may not proceed as planned and
regulatory submissions for those drug candidates may be delayed, the Company
may be unable to successfully complete pivotal clinical trials or that its
trials could be halted or terminated by regulatory authorities, regulatory
submissions may be delayed, its inability to commercialize amdoxovir and ISS-
based therapies due to patent rights held by third parties, 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.
 back to top
Related links:
http://www.tripharm.com
CONTACT:
Chris A. Rallis, President and Chief
Operating Officer, Robert Amundsen, Jr., Chief Financial Officer,
of Triangle Pharmaceuticals, Inc., +1-919-493-5980
|
