AMRI 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."
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