Kitov Pharmaceuticals, based in Israel, announces their lead product KIT-302. It combines Celecoxib (a COX-2 selective NSAID, the active ingredient in Pfizer’s Celebrex®) and Amlodipine (a neuronal calcium channel blocker), both successful products on the market.
KIT-302 (Pending FDA approval will be named Concensi for the US market) demonstrated 2.5x better blood pressure reduction than the FDA requirement and also demonstrated consistent reduction in all measures of blood pressure. In addition, the Phase 3 study observed beneficial renal functions. A second Phase III study also met all its clinical endpoints and confirmed the findings of the first study. KIT-302 is a fixed dose combination for the treatment of patients with osteoarthritic pain who experience a rise in blood pressure.
The product treats both conditions simultaneously and is expected to improve compliance. It is very late stage with two successful Phase III trial both of which met the primary efficacy endpoint at a very high level of significance (P=0.001 in one and 0.019 in another). An additional clinical trial was also completed to scientifically validate the renal benefits (not required for NDA submission). Topline results were announced in October, 2017.
The U.S. regulatory path includes both a Special Protocol Assessment (SPA) and 505(b)2. An NDA has been filed with FDA, and the company currently has a PDUFA date of end of May 2018. It also has strong IP protection in the US.
KIT-302 is formulated with 200 mg celecoxib and three different dosages (2.5, 5, 10 mg) of amlodipine in an oral dosage format. It has a low cost of goods which allows for attractive pricing and high margins. Manufacturing is currently in Israel with a third party but could be moved to India or elsewhere.
Kitov want to enter into a commercialization agreement either via a licensing agreement or through M&A. The Company has already reached a licensing agreement with a major Korean pharmaceutical company.
In the USA, there are more than 50 million patients with osteoarthritis and 25% of all adults will suffer from hypertension (65% over 60). And overall, about 45% of these adults suffer from both hypertension and osteoarthritis. A known side effect of celecoxib (which appears as a Black Box Warning on Celebrex’ package insert) is the risk of heart attack, stroke and death due to elevated blood pressure. Concensi addresses these issues by lowering blood pressure, and this may be positioned as the only NSAID that prevents these side effects.
For further information, please contact
Dr. Bill Mason
Director, The Sage Group
The Old Black Barns
Lord’s Lane, Ousden CB8 8TX UK
Phone: +44 1638 500775
Mob: +44 7785 950134