This follows Kitov’s announcement in December 2015, that KIT-302’s pivotal Phase III trial successfully met its primary efficacy endpoint.
Kitov CEO Isaac Israel said: "We are fortunate to have Dexcel as our manufacturing partner for KIT-302. Dexcel’s state-of-the-art manufacturing capabilities enabled us to reach this CMC milestone in record time, and bring KIT-302 one step closer to the NDA submission and marketing approval."
According to the Development Services Agreement executed between Kitov and Dexcel in April 2014 for KIT-302’s chemical manufacturing and control (CMC), Dexcel oversees all CMC aspects of KIT-302 including analytical methods and validation, stability testing, and production of batches for pharmacokinetics and bioequivalence studies and scale-up required for New Drug Application (NDA) submission to the FDA, expected at the end of 2016.
As part of the terms of this strategic agreement, Dexcel will pay Kitov $250,000 as a milestone payment for its right of first negotiation with regard to future marketing rights for KIT-302 and for an option to negotiate the future commercial manufacture of KIT-302. Kitov will make a milestone payment to Dexcel, which will consist of a $500,000 cash payment and 3,009,888 ordinary shares of Kitov (which are equivalent to 150,494 ADSs traded on the NASDAQ).
Dexcel is a global pharmaceutical company active in more than 30 countries including the U.S., the U.K., and Germany. Dexcel’s portfolio includes some 55 drug products, both branded and generic, and Dexcel produces some 5 billion tablets and capsules in its Israeli manufacturing facilities, which meet cGMP standards with routine oversight by the FDA.