OPKO Health and Pathogenics Announce Data Publication Demonstrating the Potential Utility of NCT in a Severe Eye Infection



-In Vitro Data Shows OPKO’s Formulation of NCT Has Promising Activity
Against Acanthamoeba Keratitis, a Serious Ocular Infection-
-Provides Additional Evidence That This Phase II Agent Has Good
Tolerability and Broad Anti-Microbial Activity Against a Wide Range of
Pathogens-

MIAMI and HINGHAM, Mass., Feb. 25 /PRNewswire-FirstCall/—OPKO
Health, Inc. (Amex: OPK) and Pathogenics, Inc. (PTGN.PK) today announced
the publication of preclinical data demonstrating the potential therapeutic
utility of their proprietary formulation of N-Chlorotaurine (NCT) in the
treatment of Acanthamoeba keratitis (AK), a serious eye infection that can
result in vision impairment or blindness. AK, which in its ocular form most
commonly infects contact lens wearers, is caused by a microscopic amoeba
parasite that is present in water, soil and air. Current treatments for
ocular AK are potentially toxic and difficult-to-handle. The study was
published in the current edition of Antimicrobial Agents and Chemotherapy.*

Led by Dr. Ursula Furnkranz of the Clinical Institute of Hygiene and
Medical Microbiology, Medical University of Vienna, Austria, the study
authors assessed NCT’s microbicidal effect on different strains of the
parasite Acanthamoeba, including both the free-living and
difficult-to-treat cystic form. The authors showed that, in vitro, NCT
clearly demonstrated amoebicidal activity at concentrations that are likely
to be well tolerated in humans. They also reported that co-treatment with
ammonium chloride appeared to further enhance NCT’s anti-parasitic
activity, including its activity against Acanthamoeba cysts, resulting in
the complete loss of viability of the infection-causing parasites. The
authors concluded that NCT might be useful as a topical drug for the
treatment of AK infections.

NCT is a derivative of a naturally occurring substance in the body with
broad anti-microbial properties. OPKO has in-licensed exclusive worldwide
development and commercialization rights to a proprietary formulation of
NCT for ocular uses from Pathogenics, Inc. OPKO is currently developing NCT
for the treatment of viral conjunctivitis, while Pathogenics is assessing
NCT in Phase II studies for topical and body cavity infections.

“These encouraging new data provide further evidence of the safety and
anti-microbial efficacy of ACU-NCT-001, OPKO’s formulation of
N-Chlorotaurine,” said Samuel Reich, Executive Vice President of OPKO
Ophthalmics. “If the broad spectrum activity of NCT continues to be
confirmed in clinical trials, its combination of tolerability and
anti-infective efficacy could make it a potentially valuable new agent for
addressing a variety of ocular infections.”

NCT has been shown to have promising anti-microbial activity against
bacteria, yeasts and molds, as well as antiviral activity against a number
of viruses. To date, NCT has been shown to be safe and well tolerated in
multiple applications, including sinus and ear infections, as well as in
viral conjunctivitis, or pink eye. Its natural sterility and absence of
preservatives make NCT especially well-suited for ocular applications.

About Acanthamoeba keratitis (AK)

Acanthamoeba keratitis is an infection of the transparent outer
covering of the eye, or the cornea, caused by a microscopic, free-living
amoeba. Acanthamoeba is commonly found in water, soil and air. AK infection
is uncommon in healthy individuals, but contact lens wearers who improperly
store or disinfect their lenses or who wear lenses while showering or
swimming are at higher risk of developing an infection. Current treatment
regimens can last a year or more and include a combination of prescription
eye medications. Severe vision impairment or loss of the eye may occur,
even if the condition is diagnosed early and managed appropriately.

* “Cytotoxic Activity of N-Chlorotaurine on Acanthamoeba spp,”
Antimicrobial Agents and Chemotherapy. (Furnkranz, U et al. Antimocrob.
Agents Chemother.2008;52:470-476).

About Pathogenics, Inc.

Pathogenics, Inc. (PTGN.PK) is a biopharmaceutical company focused on
developing its proprietary formulations of N-Chlorotaurine (NCT) for the
treatment or prevention of infections. After NCT kills a pathogen, the
agent quickly breaks down into natural substances already found in the
human body, and therefore it is likely to be extremely safe, non-toxic and
hypoallergenic. Unlike antibiotics, the way NCT kills pathogens prevents
development of drug resistance. NCT has successfully completed Phase II
studies for several topical and body cavity infections. For more
information, visit the company’s website at http://www.pathogenics.com

About OPKO Health, Inc.

Miami-based OPKO is a specialty healthcare company. Its lead
investigational drug, the pioneering gene silencing agent bevasiranib, has
entered a pivotal Phase III trial 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
markets innovative diagnostic imaging systems that complement the company’s
therapeutic products. For more information visit the company’s website at
http://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 the potential utility and benefits of NCT in treating
serious ocular infections, and our ability to develop a preclinical
pipeline of novel agents for ophthalmic diseases and to develop NCT as a
treatment for viral conjunctivitis, 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 factors 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, including
the risks that enrollment of patients for the Phase III clinical trial for
bevasiranib, may not be successful, that the Phase III clinical trial
itself may not be completed on a timely basis or at all, that any of our
compounds under development, including bevasiranib and NCT, may fail, may
not achieve the expected results or effectiveness and may not generate data
that would support the approval or marketing of products for the
indications being studied or for other indications. 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.

Contacts:

OPKO Corporate:  Pathogenics, Inc.  OPKO Media:
Steven D. Rubin Fred Zotos GendeLLindheim BioCom Partners
305 575-6000 781 556-1090 Barbara Lindheim
212 918-4650

SOURCE OPKO Health, Inc.