AMRI Announces Long-Term Manufacturing Agreement with New River Pharmaceuticals
2006年7月24日 - 10:41PM
ビジネスワイヤ(英語)
Albany Molecular Research, Inc. (Nasdaq: AMRI) today announced a
multi-year drug substance manufacturing agreement with New River
Pharmaceuticals Inc. (Nasdaq: NRPH). Financial terms were not
disclosed. Under the agreement, AMRI will manufacture the active
pharmaceutical ingredient in New River's compound, NRP104, a new
treatment for attention deficit hyperactivity disorder (ADHD) that
is currently under review with the U.S. Food and Drug
Administration. AMRI participated with New River in the development
of the chemical process to manufacture NRP104. "AMRI is delighted
to continue its relationship with New River Pharmaceuticals," said
AMRI Chairman, President and Chief Executive Officer Thomas E.
D'Ambra, Ph.D. "We are well positioned to manufacture this compound
based on our long history of manufacturing, as well as our strength
in chemical development. Our expertise and specialized capabilities
in the area of active ingredient manufacturing provide a unique and
value-added capability to AMRI customers." Krish Krishnan, New
River's Chief Financial Officer and Chief Operating Officer,
commented, "We are confident that AMRI is a solid choice for
manufacture. AMRI has the current capability of delivering a
quality product in a timely manner, leading us to conclude that it
is the best candidate for manufacturing NRP104 for an expected
product launch in the first quarter of 2007." About NRP104 NRP104
was designed as a pharmacologically inactive prodrug in which
d-amphetamine is covalently bonded to l-lysine, a naturally
occurring amino acid. It is not until undergoing hydrolysis that
the pharmacologically active d-amphetamine molecule is gradually
released, which may make drug tampering difficult and impractical.
NRP104 was designed with the expectation to have comparable
efficacy and tolerability to currently marketed once daily
extended-release stimulants with reduced potential for abuse,
diversion and overdose toxicity. NRP104 is the subject of a
collaborative development and commercialization agreement between
New River and Shire plc (LSE: SHP; Nasdaq: SHPGY; TSX: SHQ). Albany
Molecular Research, Inc. Albany Molecular Research, Inc. is a
global drug discovery company that provides chemistry services to
pharmaceutical and biotechnology companies and conducts its own
proprietary R&D programs. Statements in this press release that
are not historical facts are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. These statements may be
identified by forward-looking words such as "may," "could,"
"should," "would," "will," "intend," "expect," "anticipate,"
"believe" and "continue" or similar words and include, without
limitation, statements by the company's Chairman, CEO and President
and statements regarding the company's agreement with New River
Pharmaceuticals. Readers should not place undue reliance on our
forward-looking statements. The company's actual results may differ
materially from such forward-looking statements as a result of
numerous factors, some of which the company may not be able to
predict and may not be within the company's control. Factors that
could cause such differences include, but are not limited to the
company's ability to attract and retain experienced scientists,
trends in pharmaceutical and biotechnology companies outsourcing of
chemical research and development, the company's ability to enforce
its intellectual property and technology rights, the risks posed by
international operations to the company, and the company's ability
to effectively manage its growth as well as those factors discussed
in the company's Annual Report on Form 10-K for the year ended
December 31, 2005 as filed with the Securities and Exchange
Commission on March 16, 2006 and the company's other SEC filings.
The company does not undertake any duty to and does not intend to
update any forward-looking statements contained in this press
release after the date of this press release. New River
Pharmaceuticals Inc. New River Pharmaceuticals Inc. is a specialty
pharmaceutical company developing novel pharmaceuticals that are
generational improvements of widely prescribed drugs in large and
growing markets. For further information on New River, please visit
the company's website at www.nrpharma.com. NEW RIVER'S "SAFE
HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995 This press release contains certain forward-looking
information that is intended to be covered by the safe harbor for
"forward-looking statements" provided by the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
statements that are not historical facts. Words such as
"expect(s)," "feel(s)," "believe(s)," "will," "may,"
"anticipate(s)" and similar expressions are intended to identify
forward-looking statements. These statements include, but are not
limited to, financial projections and estimates and their
underlying assumptions; statements regarding plans, objectives and
expectations with respect to future operations, products and
services; and statements regarding future performance. Such
statements are subject to certain risks and uncertainties, many of
which are difficult to predict and generally beyond the control of
New River Pharmaceuticals, that could cause actual results to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. These risks and
uncertainties include: those discussed and identified in the New
River Pharmaceuticals Inc. annual report on Form 10-K, filed with
the SEC on March 15, 2006; the timing, progress and likelihood of
success of our product research and development programs; the
timing and status of our preclinical and clinical development of
potential drugs; the likelihood of success of our drug products in
clinical trials and the regulatory approval process; our drug
products' efficacy, abuse and tamper resistance, resistance to
intravenous abuse, onset and duration of drug action, ability to
provide protection from overdose, ability to improve patients'
symptoms, incidence of adverse events, ability to reduce opioid
tolerance, ability to reduce therapeutic variability, and ability
to reduce the risks associated with certain therapies; the ability
to develop, manufacture, launch and market our drug products; our
projections for future revenues, profitability and ability to
achieve certain sales targets; our estimates regarding our capital
requirements and our needs for additional financing; the likelihood
of obtaining favorable scheduling and labeling of our drug
products; the likelihood of regulatory approval under the Federal
Food, Drug, and Cosmetic Act without having to conduct long and
costly trials to generate all of the data which are often required
in connection with a traditional new chemical entity; our ability
to develop safer and improved versions of widely prescribed drugs
using our Carrierwave (TM) technology; and our ability to obtain
favorable patent claims. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof. New River Pharmaceuticals does not undertake any
obligation to republish revised forward-looking statements to
reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events. Readers are also urged to
carefully review and consider the various disclosures in New River
Pharmaceuticals' annual report on Form 10-K, filed with the SEC on
March 15, 2006, as well as other public filings with the SEC.
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