OPKO Health, Inc. (NYSE:OPK), a multinational biopharmaceutical and diagnostics company, today announced that the European Patent Office granted OPKO a patent covering the company’s long-acting CTP-enhanced human growth hormone product (Lagova), including composition of matter and associated methods.
The new patent provides OPKO with additional intellectual property protection covering Lagova in Europe, on top of other patents that were previously granted in the U.S. by the U.S. Patent and Trademark Office. OPKO recently announced strong positive results from a Phase 2 study of Lagova in children with growth hormone deficiency. A Phase 3 of Lagova in adults with growth hormone deficiency is ongoing.
About Lagova (hGH-CTP)
In June 2013, OPKO initiated a multi-center worldwide pivotal Phase 3 clinical trial in adults for its proprietary long-acting version of Lagova. Lagova has been awarded orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.ABOUT OPKO HEALTH OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com. SAFE HARBOR STATEMENT 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 Lagova, whether additional patents will issue for Lagova, whether our clinical trials for Lagova will be successful, whether we will successfully develop or commercialize Lagova, 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, and 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.