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OPKO Health Announces Issuance of U.S. Patent
Tuesday, March 18, 2008
Second Issued Patent for Bevasiranib Broadly Covers siRNA Targeting of VEGF Expression, Further Strengthening OPKO's RNAi Intellectual Property Portfolio
Miami, FL -- OPKO Health, Inc. today announced that it has been issued a key patent by the United States Patent and Trademark Office (USPTO) for methods related to the use and administration of small interfering RNAs (siRNAs) for targeting vascular endothelial growth factor (VEGF), including OPKO's siRNA drug candidate, bevasiranib, which is currently in a Phase III trial for the treatment of wet age-related macular degeneration (AMD).
The claims of the newly issued patent cover a broad range of methods for the use of a specific sequence of siRNA, including bevasiranib, to target VEGF. The patent also covers application of this specific sequence of siRNA to inhibit the expression of VEGF and to treat VEGF-related angiogenic disorders including age-related macular degeneration, diabetic retinopathy and cancer. In addition, the claims cover any methods of administering the siRNA, including intravenous administration, retinal injections and oral administration. This newly issued patent broadly protecting the applications of OPKO's siRNA bevasiranib is the second for the compound. In late 2006, the USPTO issued a patent covering bevasiranib's composition of matter.
"This patent marks another important step in establishing OPKO's leadership position in the promising field of siRNA-based therapeutics," said Samuel Reich, Executive Vice President of OPKO Ophthalmics. "Bevasiranib was the first siRNA to enter human trials, the first siRNA to demonstrate clinically relevant activity in patients, the first siRNA to enter a Phase III pivotal trial and now, one of the first siRNAs to receive a U.S. patent covering its broad therapeutic use. This second issued patent covering bevasiranib and its anti-VEGF applications further reinforces our confidence in our strong and growing intellectual property position in this important space. "
The newly issued patent is exclusively licensed to OPKO on a worldwide basis through an agreement with the University of Pennsylvania.
Bevasiranib is a first-in-class siRNA drug designed to silence the genes that produce vascular endothelial growth factor, believed to be largely responsible for the vision loss of wet AMD. Bevasiranib is the first therapy based on the Nobel Prize-winning RNA interference (RNAi) technology to advance to Phase III clinical trials.
The multi-national Phase III COBALT (Combining Bevasiranib And Lucentis Therapy) clinical trial of bevasiranib for the treatment of wet AMD is currently enrolling patients at multiple clinical sites. For more information about the COBALT trial, please visit http://www.opko.com/clinicaltrials.
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 preclinical 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 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 benefits of bevasiranib, our ability to establish OPKO's leadership position, our ability to aggressively engage in R&D activities and advance clinical testing of bevasiranib and our ability to develop a preclinical pipeline of novel agents for ophthalmic diseases, 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, 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.
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