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Merck and NitroMed Advance First Nitric Oxide-Enhancing
Cox-2 Inhibitor into Phase II Clinical Testing
BEDFORD, MA
June 22, 2004
NitroMed, Inc. (NASDAQ: NTMD) announced that Merck & Co., Inc.
(NYSE:MRK) has advanced its lead nitric oxide-enhancing COX-2 inhibitor
into Phase II clinical trials. NitroMed and Merck are engaged
in a three year collaboration to develop proprietary nitric oxide
COX-2 inhibitors to treat pain and inflammation and other conditions
and diseases.
"This is an important step for NitroMed in advancing its nitric
oxide technology and know-how to the next level of clinical development,"
said Michael D. Loberg, Ph.D., President and Chief Executive Officer,
NitroMed. "We are very pleased to be partnering with Merck and
recognize that this program has been steadily progressing because
of their expertise and commitment."
In January 2003, NitroMed and Merck launched a three-year exclusive,
worldwide licensing and research collaboration. To date, NitroMed
has received $23 million in payments and the research collaboration
has achieved two milestones. In December 2004, NitroMed received a
$5 million milestone payment from Merck for advancing the lead compound
into Phase I clinical testing. Under the research agreement, which
can be extended beyond the initial three year term by mutual agreement
of the parties, Merck has agreed to provide funding for scientists
and equipment, an up-front fee, certain research-based milestone payments,
and royalty payments upon successful product developments. Merck is
responsible for worldwide clinical, regulatory and commercial activities.
Under the agreement NitroMed could potentially receive up to $350
million in research and development payments, assuming multiple products
are developed for several major therapeutic areas.
About NitroMed, Inc.
NitroMed is an emerging pharmaceutical company that discovers, develops
and seeks to commercialize proprietary pharmaceuticals based on the
therapeutic benefits of the naturally occurring molecule nitric oxide.
The Company uses its expertise in nitric oxide biology and chemistry
in an effort to develop both novel drugs, as well as safer, more effective
versions of existing drugs. Research and development efforts focus
on major diseases that are characterized by a deficiency in nitric
oxide, such as cardiovascular and inflammatory diseases. BiDil, the
Company's lead product in development, is an orally administered nitric
oxide-enhancing medicine being investigated for the treatment of heart
failure in African Americans. A late-stage confirmatory trial targeted
to enroll 1,100 patients is underway in more than 160 sites throughout
the United States. The Association of Black Cardiologists is a joint
sponsor of the study. Collaborative partnerships are a key element
of the Company's business strategy. NitroMed has agreements with Merck
to jointly develop nitric oxide COX-2 inhibitors and with Boston Scientific
to jointly develop nitric oxide coated cardiovascular stents.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, as well as statements containing the
words "believes," "anticipates," "plans," "expects," "will," and similar
expressions, constitute forward-looking statements within the meaning
of The Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including risks
relating to: difficulties or delays relating to obtaining required
regulatory approvals to develop, market and sell BiDil and the Company's
other products under development; the Company's ability to successfully
complete clinical trials of BiDil and its other products under development;
the Company's dependence on corporate collaborators to develop, conduct
clinical trials of, manufacture, market and sell products based upon
its technologies, including without limitations the Company's dependence
on Merck to successfully complete clinical trials of nitric oxide-enhancing
COX-2 inhibitors; the Company's ability to obtain or maintain intellectual
property protection and required licenses for its technologies and
products under development; the Company's ability to obtain the substantial
additional funding required to conduct research and development, manufacturing,
marketing and sales of its products under development; and other factors
discussed in its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2004 and other filings that it periodically makes with the
SEC. In addition, the forward-looking statements included in this
press release represent the Company's views as of the date of this
release. Subsequent events and developments may cause the Company's
views to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company's
views as of any date subsequent to the date of this release.
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