Kitov Pharma (KTOV)
Market Cap: $16 Million
Cash $17 Million
Shares Out: 10.6 Million
Kitov Updates on KIT-302 New Drug Application
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Presentation June 2017
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
On June 26th, Kitov Pharmaceuticals (NasdaqCM: KTOV) announced it has started assembling documents required for the NDA submission of its lead asset KIT-302. KIT-302 is a fixed dose combination of celecoxib plus amlodipine being developed as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation (NasdaqGS: PRXL) to digitalize and formally submit its NDA.Recall the Company completed a Phase III trial with KIT-302 in patients with hypertension and found that the therapy significantly reduced systolic pressure in the KIT-302 treatment arm compared to competing amlodipine treatment arm. Kitov expects to file an NDA for KIT-302 during the third quarter of 2017 and potentially receive FDA approval during the second quarter of 2018. Kitov Received a $2 Million Filing Waiver from FDA
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. 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. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.
Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.
Kitov Pharma’s Arthritis Drug Meets Main Goal in Late-Stage Study
“KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers. There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”
Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib which had global sales of $2.7 billion in 2014, 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.
Dec. 17, 2015 : Kitov Pharmaceuticals Reports Additional Data from its Phase III Trial on the Beneficial Blood Pressure Effects of KIT-302
November 20, 2015 : Kitov Pharmaceuticals Holdings Announces Pricing of U.S. Initial Public Offering and NASDAQ Listing
October 21, 2015 : Kitov Pharma Announces Completion of Patient Recruitment for the Phase III Clinical Trial for KIT-302