AMRI Receives NIH Contract Award for the Formulation Development and Manufacture of Pre-Clinical and Clinical Drug Product

- 10-year Federal Contract Award Valued at up to $37 Million -

Jan 19, 2015, 08:00 ET from AMRI

ALBANY, N.Y., Jan. 19, 2015 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced it received a 10-year federal contract award from the National Institutes of Health (NIH) for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke (NINDS) award will support NIH's Drug Manufacturing and Formulation Program (DMFP), which is a component of the Blueprint Neurotherapeutics Network (BPN). AMRI has supported the NIH BPN since 2011, providing chemistry services and discovery technologies. Since 2005 AMRI has collaborated with NINDS in the area of medicinal chemistry on novel treatments for spinal muscular atrophy, a degenerative neuromuscular disease.

The ultimate goal of the DMFP is to support the NINDS and their BPN Contributors - drug companies and academic researchers – in the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical and clinical studies of neurological disease/disorders. This 10-year contract provides AMRI with funding of up to $37.3 million, based on the number of approved projects and availability of funds, to advance BPN projects having positive results in early stage drug discovery into clinical trials. Services to be provided under this contract will include the manufacture of active pharmaceutical ingredients (API); drug product formulation; analytical testing; and clinical trial supply chain management, including packaging, labeling, storage, and distribution of the completed drug product.   

"AMRI was selected for this contract award because of our proven track record on projects with NIH and our demonstrated expertise in drug manufacture and formulation, which is enriched by our integrated pharmaceutical services platform," said AMRI's President and CEO, William S. Marth. "Since our initial NIH BPN award in 2011, AMRI has provided discovery chemistry services to NINDS and its private sector BPN members on 15 drug candidate programs, and two of these programs have advanced to the stage where a pre-clinical candidate has been declared, with a third candidate pending.

This significant award demonstrates the NIH's continued focus on addressing high unmet clinical needs for patients with inadequate treatment options. We are pleased to support NIH/NINDS' efforts and provide our end-to-end expertise to the neuroscience research community and to patients who suffer from devastating neurological and degenerative diseases," added Mr. Marth.

Under the DMFP, AMRI will be responsible for completing manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for BPN compounds. AMRI will leverage its integrated service offering for formulation development, analytical services and API manufacturing, and distribution of the completed drug product.

About The National Institutes of Health (NIH) The National Institutes of Health (www.nih.gov) includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.

About AMRI Albany Molecular Research Inc. (AMRI) is a global contract research and manufacturing organization that has been working with the Life Sciences industry to improve patient outcomes and the quality of life for more than two decades. With locations in North America, Europe and Asia, our key business segments include Discovery and Development Services (DDS), Active Pharmaceutical Ingredients (API), and Drug Product Manufacturing. Our DDS segment provides comprehensive services from hit identification to IND, including expertise with diverse chemistry, library design and synthesis, in vitro biology and pharmacology, drug metabolism and pharmacokinetics, as well as natural products. API Manufacturing supports the chemical development and cGMP manufacture of complex API, including potent, controlled substances, biologics, peptides, steroids, and cytotoxic compounds. Drug Product Manufacturing supports pre-clinical through commercial scale production of complex liquid-filled and lyophilized parenteral formulations. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).

About AMRI Drug Product Manufacturing Albany Molecular Research Inc.'s (AMRI) Drug Product Manufacturing business supports the clinical formulation development and cGMP aseptic formulation and filling of complex Active Pharmaceutical Ingredients (API), including potent, controlled substances, biologics, peptides, steroids, and cytotoxic compounds. On the Drug Product side, we have expertise with supporting formulation through commercial scale production of complex liquid-filled and lyophilized parenteral formulations. We specialize in vial and pre-filled syringe manufacturing and have lyophilization capabilities for vials. AMRI has the capability to perform small batch manufacturing, but has the capacity to perform filling for larger batches to support Phase III, registration batches and commercial.

AMRI 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. Readers should not place undue reliance on our forward-looking statements. AMRI's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which AMRI may not be able to predict and may not be within the AMRI's control. Factors that could cause such differences include, but are not limited to: the quantity, nature and value of projects or programs selected by the NIH/NINDS to participate in the BPN; the quantity and value of projects or programs awarded to AMRI by NIH/NINDS under the contract; AMRI's capacity and ability to perform the services under the contract; the risk that clients may terminate or reduce demand under any strategic or multi-year deal; AMRI's ability to effectively maintain compliance with applicable FDA and DEA regulations; the ability of AMRI's strategic investments and acquisitions to perform as expected; as well as those risks discussed  in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2013 as filed with the Securities and Exchange Commission on March 17, 2014, and the company's other SEC filings.

SOURCE AMRI



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