Kitov’s KIT-302 drug achieves manufacturing milestone ahead of planned NDA Filing with FDA

This achievement follows Kitov’s announcement in May 2016 that Dexcel completed manufacturing pivotal batches of KIT-302.

Stability is a critical quality attribute of pharmaceutical products, and stability studies must be conducted in advance of registration of KIT-302 with the U.S. Food and Drug Administration (FDA). Additional stability studies required for the new drug application (NDA) are ongoing.

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 U.S. FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

"The successful completion of KIT-302’s pivotal batch initial stability study brings KIT-302 one step closer to NDA submission and market launch. We are fortunate to have Dexcel as our CMC partner for KIT-302," stated Kitov Chief Executive Officer Isaac Israel.

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 study, production of batches for pharmacokinetics and bioequivalence studies, and scale-up required for the NDA submission to the FDA.

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 approximately 5 billion tablets and capsules in its Israeli manufacturing facilities, which meet cGMP standards with routine oversight by the FDA.