Kitov Pharma Ltd. (NASDAQ:KTOV)

WEB NEWS

Thursday, May 12, 2016

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TEL-AVIV, Israel, May 12, 2016 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today the U.S. Patent and Trademark Office has issued a Notice of Allowance to the Company for claims covering important treatment methodologies, which form the basis of its lead drug candidate, KIT-302, and that ameliorate celecoxib-induced elevation of blood pressure, which can result from prolonged use of the drug. 

A combination drug, KIT-302 simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain.   KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension. The Company plans to file a New Drug Application for KIT-302 at the end of 2016.

"This patent is expected to provide Kitov a proprietary position and long-term market exclusivity for its lead compound, KIT-302, creating a high barrier to entry for potential competitors in the U.S., our major target market" stated Kitov CEO, Isaac Israel.

In other news today...

KTOV announced it has received, from the U.S. Food and  Drug Administration (FDA), meeting minutes from its recent pre-New Drug Application meeting for KIT-302 . Based on the details of the FDA's response, Kitov is on track to submit the NDA for marketing approval of KIT-302 by the end of 2016.    

The meeting, which took place on April 11, 2016, had been requested by Kitov to seek FDA concurrence that the NDA content will meet the agency's requirements for NDA submission.

The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission. Furthermore, based on  the minutes, the Company will include additional information as part of the planned NDA submission, such as market data and a medical literature review on the use of amlodipine and celecoxib in animals. The  FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint.

"These minutes bring us closer to submitting an NDA to the FDA for KIT-302 via the 505(b)(2) path at the end 2016, as currently planned. This paves the way for potential regulatory approval in 2017," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain.  KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.