MIAMI, March 18 OPKO Health, Inc. (Amex: OPK)today announced that it has been issued a key patent by the United StatesPatent and Trademark Office (USPTO) for methods related to the use andadministration of small interfering RNAs (siRNAs) for targeting vascularendothelial growth factor (VEGF), including OPKO's siRNA drug candidate,bevasiranib, which is currently in a Phase III trial for the treatment of wetage-related macular degeneration (AMD).
The claims of the newly issued patent cover a broad range of methods forthe use of a specific sequence of siRNA, including bevasiranib, to targetVEGF. The patent also covers application of this specific sequence of siRNAto inhibit the expression of VEGF and to treat VEGF-related angiogenicdisorders including age-related macular degeneration, diabetic retinopathy andcancer. In addition, the claims cover any methods of administering the siRNA,including intravenous administration, retinal injections and oraladministration. This newly issued patent broadly protecting the applicationsof OPKO's siRNA bevasiranib is the second for the compound. In late 2006, theUSPTO issued a patent covering bevasiranib's composition of matter.
"This patent marks another important step in establishing OPKO'sleadership position in the promising field of siRNA-based therapeutics," saidSamuel Reich, Executive Vice President of OPKO Ophthalmics. "Bevasiranib wasthe first siRNA to enter human trials, the first siRNA to demonstrateclinically relevant activity in patients, the first siRNA to enter a Phase IIIpivotal trial and now, one of the first siRNAs to receive a U.S. patentcovering its broad therapeutic use. This second issued patent coveringbevasiranib and its anti-VEGF applications further reinforces our confidencein our strong and growing intellectual property position in this importantspace. "
The newly issued patent is exclusively licensed to OPKO on a worldwidebasis through an agreement with the University of Pennsylvania.
Bevasiranib is a first-in-class siRNA drug designed to silence the genesthat produce vascular endothelial growth factor, believed to be largelyresponsible for the vision loss of wet AMD. Bevasiranib is the first therapybased on the Nobel Prize-winning RNA interference (RNAi) technology to advanceto Phase III clinical trials.
The multi-national Phase III COBALT (Combining Bevasiranib And LucentisTherapy) clinical trial of bevasiranib for the treatment of wet AMD iscurrently enrolling patients at multiple clinical sites. For more informationabout the COBALT trial, please visit www.opko.com/clinicaltrials.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its leadinvestigational drug, the pioneering gene silencing agent bevasiranib, hasentered a pivotal Phase III trial after successfully completing Phase IItrials for wet age-related macular degeneration and diabetic macular edema.OPKO is developing a preclinical pipeline of novel agents for ophthalmicdiseases, and it markets innovative diagnostic imaging systems that complementthe company's therapeutic products. For more information visit the company'swebsite at www.opko.com.
This press release contains "forward-looking statements," as that term isdefined 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 statementsregarding the potential benefits of bevasiranib, our ability to establishOPKO's leadership position, our ability to aggressively engage in R&Dactivities and advance clinical testing of bevasiranib and our ability todevelop a preclinical pipeline of novel agents for ophthalmic diseases, aswell as other non-historical statements about our expectations, beli