OPKO’s Citicoline Products Approved for Commercialization in Spain
MIAMI -- July 24, 2013
OPKO Health, Inc. (NYSE:OPK) announced that its Barcelona, Spain subsidiary,
Pharmadiet, S.L.U., received regulatory approval from Spain’s health authority
(Agencia Española de Medicamentos y Productos Sanitarios) for
commercialization of its oral and injectable formulations of citicoline. Final
marketing authorization is expected within 60 to 90 days.
Sales of the other citicoline product presently available in Spain, Somazina®,
exceeded $80 million in 2012. Citicoline also enjoys strong sales throughout
Latin America, including those countries where OPKO maintains a growing
"OPKO plans to commercialize its oral and injectable citicoline products in
Europe, Latin America, and other markets as well,” said Phillip Frost, M.D.,
OPKO's Chairman and Chief Executive Officer.
Citicoline products are indicated for the treatment of memory disorders and
behavior related to stroke, head injury, chronic disease, as well as
degenerative brain disorders. Citicoline enhances the level of
phosphatidylcholine in the brain.
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that seeks
to establish industry-leading positions in large and rapidly growing medical
markets by leveraging our discovery, development and commercialization
expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is
defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
which statements may be identified by words such as "expects," "plans,"
"projects," "will," "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including statements
regarding expected financial performance, the market for and expected sales of
citicoline products, our ability to commercialize citicoline products in
Spain, Europe, Latin America and other markets, and expectations regarding
timing for final marketing authorization for our citicoline products, as well
as other non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products, financial
condition, strategies or prospects. Many factors could cause our actual
activities or results to differ materially from the activities and results
anticipated in forward-looking statements. These factors include those
described in our filings with the Securities and Exchange Commission, as well
as the risks inherent in funding, developing and obtaining regulatory
approvals of new, commercially-viable and competitive products and treatments.
In addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory process for new
products and indications, manufacturing issues that may arise, patent
positions and litigation, among other factors. The forward-looking statements
contained in this press release speak only as of the date the statements were
made, and we do not undertake any obligation to update forward-looking
statements. We intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Juan F. Rodriguez, 305-575-4100
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