AMRI Announces First Product Approval Out of its Massachusetts Aseptic Fill Finish Site

First Alcohol-Free Formulation Provides U.S. Patients with Alternative to Traditional Docetaxel Injection Treatment

Jan 11, 2016, 06:45 ET from AMRI

ALBANY, N.Y., Jan. 11, 2016 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced that Docetaxel Injection (non-alcohol formula) has been approved for commercial manufacture at its Burlington, Mass. aseptic fill-and-finish facility following U.S. Food and Drug Administration's (FDA) pre-approval inspection for this drug product.

Eagle Pharmaceuticals, Inc., which entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the United States, announced the FDA's U.S. approval of Docetaxel Injection in December 2015. Docetaxel Injection is the first alcohol-free formulation approved in the United States for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

William S. Marth, President and CEO, of AMRI, said, "AMRI is excited to have been able to work with Eagle to meet this important unmet medical need in the market. The Docetaxel non-alcohol drug product attributes, as well as the manufacturing process itself, are considered to be both unique and challenging with the process containing several critical process control parameters. This commercial scale process has been successfully developed and validated at the AMRI Burlington facility."

AMRI provides integrated development, formulation, and commercial parenteral solutions, which includes pre-formulation, formulation and process development; cGMP injectable formulation development and clinical drug product; and late phase and commercial parenteral manufacturing. AMRI's Burlington, Mass. facility is expertly equipped to provide formulation development, cGMP manufacturing and sterile filling of parenteral drugs – including both small molecule drug products as well as biologicals – using various specialized technologies.   

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 (DPM). 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 supports the chemical development and cGMP manufacture of complex API, including potent, controlled substances, biologics, peptides, steroids, hormones, cytotoxic compounds and sterile API. DPM supports development through commercial scale production of complex liquid-filled and lyophilized parenterals, sterile suspensions and ophthalmic formulations. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle's strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the company's website at www.eagleus.com.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties.  These statements include, but are not limited to, statements regarding expected future performance of AMRI, statements regarding U.S. Food and Drug Administration approval, and statements made by AMRI's President and CEO.  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 AMRI's control.  Factors that could cause differences include, but are not limited to, decisions by the FDA; trends in pharmaceutical and biotechnology companies' outsourcing of chemical research and development, including softness in these markets; 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 AMRI's Annual Report on Form 10-K for the fiscal year ended December 31, 2014 as filed with the Securities and Exchange Commission on March 16, 2015, and AMRI's other SEC filings.

SOURCE AMRI



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