June 12, 2008 8:00am EDT
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--Novel Agent Has Demonstrated Good Safety and Antiviral Activity in Viral Conjunctivitis--
--Unique Combination of Anti-Infective and Anti-Inflammatory Properties Offers Potential for Broad-Based Ocular Applications--
MIAMI, June 12 /PRNewswire-FirstCall/ -- OPKO Health, Inc. (AMEX: OPK)
today announced that it has acquired exclusive worldwide rights in the field
of ophthalmology to a novel small molecule agent in Phase II clinical
development for the treatment of viral conjunctivitis and other viral
infections. The agent, CTC-96, also known as Doxovir(TM), was developed by
Redox Pharmaceutical Corporation. It is a member of a novel drug class that
has demonstrated potent anti-viral activity and non-steroidal
anti-inflammatory properties with good safety in preclinical and human
clinical testing.
"Viral conjunctivitis, popularly known as "pink eye," is among the most
common eye disorders, yet patients have no real treatment options for this
unsightly, uncomfortable and debilitating condition," said Naveed Shams, M.D.,
Ph.D., Chief Medical Officer and Senior Vice President of Research and
Development of OPKO. "The potent anti-viral activity of CTC-96, its
anti-inflammatory properties and its good safety profile make it a potentially
ideal candidate for the treatment of viral conjunctivitis."
CTC-96's novel anti-viral mechanism has demonstrated efficacy against
multiple viral infections in preclinical studies. CTC-96 should be less
susceptible to development of viral resistance than other anti-viral drugs
because it disrupts the viral lifecycle by interfering with viral assembly.
CTC-96 has anti-inflammatory properties but it is a non-steroidal compound, an
important safety advantage for an ocular drug. CTC-96 has successfully
completed randomized double-blinded Phase I trials for the treatment of
adenovirus keratoconjunctivitis and for the treatment of ocular herpes
infection, a leading cause of persistent corneal disease in the developed
world.
"This product candidate illustrates our strategy of acquiring agents that
address unmet needs in ophthalmology and have a significant commercial
upside," said Samuel Reich, OPKO's Executive Vice President of Ophthalmics.
"We look forward to initiating Phase II trials assessing CTC-96 for the
treatment of viral conjunctivitis in the coming months."
About Viral Conjunctivitis
Adenovirus keratoconjunctivitis is a highly contagious epidemic disease.
Viral conjunctivitis is the most common source of acute care visits to eye
care professionals in the U.S. Symptoms of viral conjunctivitis include
redness, swelling, discharge from the eye, sticking of eyelids, pain or
discomfort in the eye and light sensitivity. In 20-50% of cases, corneal
opacities accompany the condition and can persist for weeks to months, or even
several years. Corticosteroids may be used to limit corneal damage but can
have significant side effects and also interfere with viral clearance.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead
investigational drug, the gene silencing agent bevasiranib, is in Phase III
trials after successfully completing Phase II trials for wet age-related
macular degeneration and diabetic macular edema. OPKO is developing a
pipeline of novel agents for ophthalmic diseases, and it markets innovative
diagnostic imaging systems that complement the company's therapeutic products.
For more information visit the company's website at www.opko.com .
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 our product development efforts, our ability to develop a
preclinical pipeline of novel agents for ophthalmic diseases, the
effectiveness of CTC-96 in treating viral conjunctivitis and its potential for
broad spectrum ocular use, the timing of Phase II trials for CTC-96, and the
safety, costs, and effectiveness of CTC-96, 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 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.
Steven D. Rubin
GendeLLindheim BioCom Partners
Barbara Lindheim
SOURCE OPKO Health, Inc.
Released June 12, 2008
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