New River (NASDAQ:NRPH)
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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.