-- Significantly Expands AMRI's Portfolio of Controlled
Substances --
ALBANY, New York, Aug. 31, 2015 /PRNewswire/ -- 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."
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 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.