Novartis acquires Kyorin's preclinical chronic hives drug for $55M upfront

Novartis has entered into a significant agreement with Kyorin Pharmaceutical, investing $55 million for worldwide rights to Kyorin's preclinical drug aimed at treating inflammatory diseases. This partnership comes nearly twenty years after Novartis first collaborated with the Japanese pharmaceutical company. As part of the deal, Novartis will gain exclusive rights to develop, produce, and commercialize Kyorin's MRGPRX2 antagonist, named KRP-M223. According to a company announcement made on Monday, Kyorin stands to earn up to $777.5 million in milestone payments in addition to tiered royalties based on sales. However, the timeline for the drug's progression to clinical trials has not been disclosed.

Under this agreement, Novartis will oversee the global development of KRP-M223, while Kyorin retains the option to manufacture and market the drug within Japan. KRP-M223 is designed to address a variety of conditions triggered by mast cells, such as chronic spontaneous urticaria (CSU). CSU is characterized by spontaneous outbreaks of hives and swelling that can persist for over six weeks and is estimated to impact approximately 40 million individuals globally.

Kyorin’s therapy operates by inhibiting MRGPRX2, a protein associated with the activation of mast cells. These cells release substances like histamine and tryptase, which cause symptoms such as itching and swelling. This mechanism potentially offers a new avenue for treating CSU and other similar conditions.

The progress of medications targeting MRGPRX2 has faced challenges, as evidenced by Incyte’s INCB000262. In November, Incyte encountered preclinical safety issues that led to a suspension of enrollment in a Phase 2 trial for CSU. In the landscape of CSU treatments, other more advanced drug candidates target the c-Kit protein. Notable among these are Celldex’s barzolvolimab and Jasper Therapeutics’ briquilimab, both of which are undergoing mid-stage clinical testing.

Novartis' history with Kyorin dates back to 2006, when it acquired rights to Kyorin’s immunosuppressant drug KRP-203. However, that project was eventually discontinued. In a related development, 2020 saw two former Novartis executives initiate a company called Priothera Limited. This new venture aims to further develop KRP-203, specifically targeting patients with acute myeloid leukemia undergoing hematopoietic stem cell transplants. While Novartis and Kyorin’s past collaboration did not fully materialize, the renewed partnership signifies a continued interest in exploring innovative treatments for challenging conditions.