Michael L. Sabolinski, M.D. Resigns from NitroMed
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NitroMed, Inc. (NASDAQ:NTMD) announced that Michael L. Sabolinski, M.D.
will resign as chief medical officer of the Company, effective at the
end of the month. After fourteen months in this role and four years with
the company, Dr. Sabolinski is leaving to become a partner at FOXKISER a
public health policy, regulatory and drug development firm.
Dr. Sabolinski succeeded company co-founder Manuel Worcel, M.D. in the
role of chief medical officer. Dr. Worcel continues to support the
Company part-time as medical and scientific advisor. In this capacity,
Dr. Worcel supports various clinical and marketing efforts, and
participates in key decision-making processes relative to the
development of BiDil®
(isosorbide dinitrate/hydralazine hydrochloride) outside of the United
States as well as the development of an extended release formulation of
BiDil. Dr. Worcel co-founded NitroMed to develop nitric oxide-based
drugs. He served from 1993 to 1997 as NitroMed’s
chief executive officer, and from 1997 until last year as chief medical
officer.
Dr. Sabolinski joined NitroMed in 2002 as senior vice president for
clinical development and regulatory affairs, with over twenty years of
experience in the pharmaceutical industry. Dr. Sabolinski joined
NitroMed from Organogenesis, Inc. where he held several positions
including president and chief executive officer, head of clinical
research and regulatory affairs, and corporate development.
"We greatly appreciate Mike’s
enduring contribution to the company including his instrumental role in
guiding BiDil®
through the FDA regulatory approval process and his contribution to the
field of drug development for sub-populations,”
said Ken Bate, NitroMed’s chief executive
officer. "He will be missed.” About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical
company and the maker of BiDil®
(isosorbide dinitrate/hydralazine hydrochloride), an orally administered
medicine available in the United States for the treatment of heart
failure in self-identified black patients. In this population, BiDil®
is indicated as an adjunct to current standard therapies such as ACE
inhibitors and/or beta blockers. BiDil®
was approved by the U.S. Food and Drug Administration, primarily on the
basis of efficacy data from the Company’s
landmark A-HeFT (African American Heart Failure Trial) clinical trial,
and is marketed by NitroMed.
For full prescribing information, visit: www.BiDil.com.
BiDil® is a
registered trademark of NitroMed, Inc.
Forward Looking Statements
Statements in this press release about future expectations, plans and
prospects for the Company, including the Company’s
expectations regarding the effect of its operational restructurings, its
expectations regarding cash management and operating expenses in 2007,
its positioning to achieve the Company’s
goals and objectives in 2007, and its plans to increase value for the
Company and its stockholders, 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 in successfully developing,
obtaining regulatory approval for, manufacturing and commercializing
BiDil XR™, including the Company’s
ability to maintain third-party relationships for the development and
manufacture of clinical and commercial quantities of BiDil XR on
favorable terms, if at all; the Company’s
ability to execute on its revised sales and marketing strategy including
without limitation, the Company’s inability
to achieve anticipated cost reductions, the Company’s
ability to successfully market and increase the sales of BiDil with
limited sales force support and centralized marketing efforts, the
Company’s ability to recruit the specialized
sales representatives necessary to execute on this strategy, and the
Company’s ability to successfully enter into
a co-promotion agreement for BiDil on favorable terms, if at all; the
Company’s ability to enter into collaboration
or licensing arrangements with strategic partners related to its product
candidate portfolio on favorable terms, if at all; the Company’s
ability to obtain the substantial additional funding required to conduct
manufacturing, marketing and sales of BiDil and to develop, conduct
clinical trials for and, if approved, commercialize BiDil XR; patient,
physician and third-party payer acceptance of BiDil and/or BiDil XR as a
safe and effective therapeutic; the Company’s
ability to obtain or maintain intellectual property protection and
required licenses; unanticipated operating expenses for the remainder of
fiscal year 2007 and beyond; and other important factors discussed in
the Section titled "Risk Factors”
in the Company’s Quarterly Report on Form
10-Q for the period ended September 30, 2006, which has been filed with
the SEC. The forward-looking statements included in this press release
represent the Company’s views as of the date
of this release. The Company anticipates that subsequent events and
developments will 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.
