Kowa Pharmaceuticals America, a specialty pharmaceutical company, has plans to divest its franchise of diclofenac products, including PRO-513 for the treatment of acute migraine headache pain and PRO-571 for the treatment of acute pain.
After a thorough review of its research & development portfolio, Kowa Pharmaceuticals America (KPA) has determined that the migraine and pain product candidates are not strategically aligned with KPA’s long-term vision to become a leader in the cardiometabolic therapeutic arena. KPA has appointed Robert Baird & Co as its exclusive financial advisor with regard to a transaction involving these assets.
The assets to be divested are patent protected diclofenac-based non-steroidal anti-inflammatory drugs that are combined with potassium bicarbonate, resulting in rapid and consistent absorption of diclofenac, leading to faster and higher peak blood concentrations than other approved dosage forms of diclofenac.
KPA licensed rights to PRO-513 (Cambiatm) and PRO-571 from Applied Pharma Research (APR) of Balerna, Switzerland. The APR license provides KPA with exclusive rights to market, distribute and commercialize Cambiatm and PRO-571, as well as other yet to be developed products in the US and Canada.
Cambiatm is a powder for oral solution that will compete in the migraine pain market, while PRO-571 is formulated as a tablet intended for use in the broader acute pain category. The NDA for Cambiatm is currently being reviewed by the FDA. PRO-571 is currently entering into late-stage clinical trials.
Ben Stakely, CEO and president of KPA, said: Although this novel diclofenac franchise represents an extremely compelling part of KPA’s portfolio, our foremost priority is our company’s extensive cardiometabolic pipeline. We will continue to focus our resources toward the successful sales and marketing of this pipeline, leveraging our current expertise with Lipofen.