Kitov's Lead Drug Achieves Manufacturing Milestone Ahead of Planned NDA Filing With US FDA
Kitov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, recently announced that Dexcel Pharma, Kitov’s manufacturing partner, has successfully completed an initial stability study for its lead drug candidate KIT-302. 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 US 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 composed of two US 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,” said 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 US, the UK, 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.
Kitov Pharmaceuticals is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s pipeline currently features two combination drugs intended to treat osteoarthritis pain and hypertension simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. Lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information, visit www.kitovpharma.com.
Total Page Views: 1144
