Albany, New York - AMRI (NASDAQ: AMRI) and Saneca Pharmaceuticals, a.s. today announced a strategic collaboration focused on the development, manufacture and marketing of a portfolio of opium-derived active pharmaceutical ingredients, (“APIs”).
The collaboration combines Saneca’s strength in extracting opiates from plant biomass and their expertise in developing and manufacturing controlled substance APIs with AMRI’s U.S. assets and their ability to tech transfer processes into these facilities. The collaboration will also capitalize on AMRI’s sales and marketing strength in the U.S. market.
Under terms of the collaboration, Saneca will supply intermediates, and where appropriate, process transfer technology to enable AMRI to develop over two dozen APIs. Based on customer demand, AMRI will prepare the U.S. regulatory filings, and following FDA approval, will manufacture the APIs at its U.S. DEA approved facilities. The companies will share revenue of any marketed APIs resulting from the collaboration. Additional details of the agreement have not been disclosed.
“We very pleased to be entering into this strategic collaboration with Saneca,” said George Svokos, Senior Vice President and Chief Commercial Officer, AMRI. “This alliance allows us to not only expand our portfolio of controlled substance APIs, but it also allows us to be fully integrated with a competitive cost structure.”
“Collaborating with AMRI will allow us to mutually benefit from our strengths and capabilities in developing and manufacturing controlled substance APIs, further accelerating and strengthening our ability to expand into new markets with existing and new opium-derived products,” said Anthony Sheehan, Group CEO, Saneca. “Coupled with its robust operating procedures and strong quality management systems, the key to AMRI’s success is its unique ability to implement and validate a diverse range of technical processes at their U.S. facilities. This will ultimately provide us with the ability to manufacture and market opiates in the U.S. market in compliance with cGMP regulations.”
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 Solutions (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 Saneca Pharmaceuticals, a.s.
Saneca Pharmaceuticals is a supplier to the global pharmaceutical and healthcare industry. The company develops and produces high quality pharmaceutical dosage forms, including solid, liquids, gels and creams. In addition, we have a portfolio of synthetic APIs, and opiate APIs from plant biomass. Our entire portfolio covers a wide range of therapeutic categories, and reaction capabilities. Established originally in 1940 with regular investments, the company has developed an experienced management team, covering formulation production and development, API synthesis and development and distribution, with an established regulatory and HSE record, and modern plant operating under cGMP conditions.
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 the abilities of AMRI to successfully transfer certain product manufacturing processes from Saneca, obtain necessary import and other regulatory licenses required to import certain materials, obtain US FDA regulatory approval of drug master files to manufacture and supply certain products to the commercial market, and successfully sell to third parties various APIs covered under the collaboration. 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 ability of the company to successfully manufacture the APIs covered under the collaboration; trends in pharmaceutical and biotechnology companies’ outsourcing of manufacturing services, including softness in these markets; changes in US and ex-US regulatory and legal provisions applicable to the import, export, manufacture and possession of opium-derived products; the success of the sales of products covered under the collaboration; the company’s ability to manufacture and sell APIs free of intellectual property infringement claims by third parties; the company’s ability to enforce its intellectual property and technology rights; the company’s ability to obtain financing sufficient to meet its business needs; the company’s ability to successfully comply with applicable controlled substance regulatory requirements, including but not limited to those of the US DEA; the results of further FDA inspections; the company’s ability to effectively maintain compliance with applicable FDA regulations; the company’s ability to take advantage of proprietary technology and expand the scientific tools available to it, as well as those risks discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2014 as filed with the Securities and Exchange Commission on March 16, 2015, and the company’s other SEC filings.