OPKO Acquires Rights to Novel Phase II Agent to Treat Viral Conjunctivitis
--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.
Contacts: Corporate: Steven D. Rubin 305 575-6015 Media: GendeLLindheim BioCom Partners Barbara Lindheim 212 918-4650
SOURCE OPKO Health, Inc.
Released June 12, 2008