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02.06.2009 12:00

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AMRI Advances New Obesity Treatment Toward IND Submission

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AMRI (NASDAQ:AMRI) today announced the selection of a compound from its proprietary obesity treatment research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2010.

AMRI’s drug candidate is a novel MCH-1 receptor antagonist offering a promising new approach for the treatment of obesity. Melanin concentrating hormone (MCH) is a potent appetite stimulating peptide known to exert an effect on food intake and body weight regulation. In preclinical disease models, AMRI’s small molecule antagonists of the MCH-1 receptor have demonstrated efficacy in rodent models of obesity, delivering weight loss that rivals currently available therapeutics, suggesting the potential for improved therapy in humans.

Pending favorable results in toxicity and safety pharmacology testing, AMRI estimates that it will submit an IND for this compound in the first half of 2010. Subject to FDA review, the submission of an IND would allow subsequent initiation of Phase I human clinical trials.

"We are pleased to announce this latest achievement emerging from our R&D efforts. This development results from our strategy of deploying dedicated resources and talent to create long term value for AMRI and its stakeholders,” said Chairman, CEO and President Thomas E. D’Ambra, Ph.D. "This research program leveraged AMRI’s exceptional strength in medicinal chemistry and depth of expertise in metabolic diseases.”

AMRI has filed a series of patent applications to protect the intellectual property associated with this program, and plans to ultimately seek a licensee to commercialize the technology.

Today’s announcement marks the sixth AMRI compound transitioned into an early stage preclinical candidate. Three of these candidates have moved into Phase I clinical testing, including two compounds from AMRI’s biogenic amines program being studied for the treatment of central nervous system (CNS) disorders by Bristol-Myers Squibb Company (NYSE:BMY) as part of a licensing arrangement, and one from AMRI’s independent tubulin inhibitor program, which is currently in Phase I testing in cancer patients.

About the MCH-1 Receptor

Antagonism of the MCH-1 receptor is a promising new approach for the treatment of obesity. The endogenous peptide MCH is believed to regulate energy homeostasis through neurons in the lateral hypothalamic area of the central nervous system (CNS). It is known to stimulate feeding in rats and promote increases in glucose, insulin and leptin levels, mimicking the human metabolic syndrome. Antagonism of the MCH-1 receptor has been shown to reduce food intake and hence reduce body weight, selectively reducing fat stores. This target has been a focus of interest in many pharmaceutical companies but most programs have stalled in the face of preclinical safety challenges. AMRI’s candidate compound has performed remarkably well in early preclinical safety studies and has potential to demonstrate an appropriate balance of efficacy to safety.

About AMRI

Founded in 1991, Albany Molecular Research, Inc. (AMRI) provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the U.S., Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.

Forward-Looking Statement

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 regarding the company's clinical development plans for its proprietary compounds, the company’s research programs and the license arrangement with BMS concerning the company’s biogenic amines program. 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 delay or denial of approvals from the FDA, potential changes in the cost, scope and duration of clinical trials as compared to the company’s current expectations, 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, 2008 as filed with the Securities and Exchange Commission on March 13, 2009 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.

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