Blog Coverage Kitov Received a $2 Million Filing Waiver from FDA

Upcoming AWS Coverage on Protalix BioTherapeutics Post-Earnings Results

LONDON, UK / ACCESSWIRE / April 4, 2017 / Active Wall St. blog coverage looks at the headline from Kitov Pharmaceuticals Holdings LTD (NASDAQ: KTOV) as the Company announced that the US Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. Register with us now for your free membership and blog access at:

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One of Kitov Pharma’s competitors within the Biotechnology space, Protalix BioTherapeutics, Inc. (NYSE MKT: PLX), reported on March 16, 2017, its financial results for the full-year ended December 31, 2016, and provided a corporate update. AWS will be initiating a research report on Protalix BioTherapeutics in the coming days.

Today, AWS is promoting its blog coverage on KTOV; touching on PLX. Get all of our free blog coverage and more by clicking on the link below:

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KIT-302

Kitov’s flagship combination drug, KIT-302 is a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5 mg, 5 mg, or 10 mg of amlodipine, indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant pre-existing condition. KIT-302 is comprised of two US Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase-III trial, with the US FDA during Q1 2017.

J. Paul Waymack, M.D., Sc.D., Kitov’s Chairman of the Board and Chief Medical Officer, commented:

“We are pleased to receive this NDA fee waiver for KIT-302 and look forward to continuing to work with the FDA through the NDA submission and review process. We are focused on finalizing our NDA submission to the FDA, which we expect will occur during the current calendar quarter.”

The fee waiver, which Kitov requested in accordance with sections 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for its first human drug application submitted to the FDA for review. The Company will not be required to remit the NDA filing fee, provided that the marketing application for KIT-302 is filed prior to March 27, 2018.

Kit -302 Recent Developments

On December 07, 2017, Kitov announced that KIT-302 met the US FDA standards for establishing six months’ stability.

The study, conducted by Kitov’s manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three in each dosage forms met the criteria demonstrating stability for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application (NDA) submission which is planned during Q1 2017. The Certificate of Analysis demonstrated adequate stability required for submission, in accordance with FDA’s guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend the labeled shelf life.

On February 01, 2017, Kitov 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.

On March 08, 2017, Kitov signed a definitive License Agreement for its lead product candidate, KIT-302, for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd. Upon receipt of marketing authorization in South Korea, Kuhnil Pharma will have the exclusive right and license to manufacture, distribute, and sell KIT-302 in South Korea. Kuhnil Pharma will be responsible for seeking regulatory approval for KIT-302 in South Korea.

Under terms of the agreement, Kitov is entitled to receive milestone payments upon achievement of certain predefined regulatory milestones, as well as double digit royalties on net sales. The initial terms of the definitive agreement with Kuhnil Pharma is for ten years from the date of first commercial sale and will automatically renew for an additional one-year term. Commercial launch in South Korea is estimated to take place in 2019.

Stock Performance

At the close of trading session on Monday, April 03, 2017, Kitov Pharma’s stock price jumped 5.70% to end the day at $2.04. A total volume of 70.61 thousand shares were exchanged during the session. Kitov Pharma’s stock has gained 4.08% in the past one month The stock currently has a market cap of $160.18 million.

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