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.
New River (NASDAQ:NRPH)
Historical Stock Chart
Von Mai 2024 bis Jun 2024 Click Here for more New River Charts.
New River (NASDAQ:NRPH)
Historical Stock Chart
Von Jun 2023 bis Jun 2024 Click Here for more New River Charts.