Kitov Pharmaceuticals Holdings Ltd., an innovative biopharmaceutical company, has announced that the US Patent and Trademark Office has issued a notice of allowance to the company related to claims expanding the patent coverage for its lead drug candidate, KIT-302, to include oral dosage compositions containing both amlodipine and celecoxib.

"This notice of allowance should result in the issuance of an additional patent, which is expected to further strengthen Kitov's proprietary position and long-term US market exclusivity for our lead compound, KIT-302, creating a higher barrier to entry for potential competitors. We plan to continue to evaluate and grow intellectual property rights of our amlodipine/celecoxib combination platform," stated Kitov chief executive officer, Isaac Israel.  

Israel further noted, "The preparation of our New Drug Application (NDA) for KIT-302 to be submitted to the US Food and Drug Administration is continuing and is expected to be completed within the first quarter of 2017, as scheduled."

In August 2016, Kitov Pharmaceuticals Ltd., Kitov's wholly owned subsidiary, was awarded US Patent 9,408,837. That patent covers methods of ameliorating celecoxib-induced elevation of blood pressure by providing a subject with celecoxib and amlodipine, where the amlodipine reduces blood pressure elevation caused by the celecoxib.  Kitov Pharmaceuticals, Ltd. has now obtained a notice of allowance on a continuation application filed from the application which yielded Patent 9,408,837. The new patent, which is expected to issue from the continuation application in the next few months, is expected to expand the sphere of protection over Kitov's amlodipine/celecoxib combination therapy by having claims which cover oral dosage compositions containing both amlodipine and celecoxib. Examples of oral dosage compositions include capsules, gelcaps, caplets, tablets, and liquids.  These claims are expected to cover oral dosage compositions containing both the combination of amlodipine and celecoxib alone or together with other compounds or ingredients.

Kitov Pharmaceuticals is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare and research professionals maintains a proven track record in streamlined end-to-end drug development and approval.