October 21, 2013 1:11pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK) announced that its Barcelona, Spain
subsidiary, Pharmadiet, S.L.U. (“Pharmadiet”), received final marketing
approval from Spain's health authority (Agencia Española de Medicamentos
y Productos Sanitarios) for commercialization of its oral and injectable
formulations of citicoline. OPKO expects to begin commercialization in
Spain of its citicoline products during the first quarter of 2014. OPKO
expects that the products will be significant contributors to
Pharmadiet’s sales and earnings.
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 presence.
About Citicoline
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 and other markets, and
expectations regarding timing for commencement of sales and that sales
of the products will be a significant contributor to Pharmadiet’s sales
and earnings, 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,
Source: OPKO Health, Inc.
Released October 21, 2013
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