ALBANY, N.Y., Jan. 12, 2015 /PRNewswire/ — AMRI (NASDAQ: AMRI) today announced that it has entered into several development and supply agreements with Genovi Pharmaceuticals Limited ("Genovi"), a specialty generic pharmaceutical company, to manufacture select generic parenteral drug products for registration and subsequent commercialization in the U.S., Europe, and select emerging markets.
Under the terms of the agreements, AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. AMRI will be reimbursed for technology transfer activities, analytical development and manufacture of regulatory submission batches. In addition, AMRI is eligible to receive additional payments for achieving product delivery milestones. Following U.S. Food and Drug Administration approval, AMRI will supply the products to Genovi pursuant to the agreements, and for some products, receive payments based on Genovi’s sales of the products. Financial details of the agreements have not been disclosed.
"We are very pleased that Genovi has chosen AMRI for these services as this validates our stated strategy of providing an integrated service offering for development, analytical services, and commercial scale manufacturing of strategic and complex injectable products," said Milton Boyer, Vice President, Parenterals. "We continue to build the pipeline for 2015 and appreciate the opportunity that Genovi has provided AMRI, based on its experience and capabilities to address customer’s sterile fill/finish needs from early stage development to commercial scale for these important products."
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.
About Genovi Pharmaceuticals Limited
Genovi Pharmaceuticals Limited, along with it affiliates, is an emerging leader in specialty parenteral pharmaceutical products with operations in North America and Asia. Genovi engages in the research, development, manufacturing and marketing of high-barrier generic products as well as enhanced versions of drugs following the 505(b)(2) regulatory pathway. Genovi’s vision is to become an integral and indispensable provider of specialty parenteral pharmaceutical products to pharmacists, physicians, and ultimately patients.
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 each of AMRI and Genovi under the agreements, statements regarding U.S. Food and Drug Administration approval, and statements made by the company’s Vice President, Parenterals. 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 differences include, but are not limited to, Genovi’s ability to terminate the agreements on short notice; 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; the company’s ability to effectively maintain compliance with applicable FDA and DEA regulations; the ability of the company’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.