Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) has recently announced an exclusive license, supply, and commercialization agreement with Kye Pharmaceuticals Inc. for Agamree® (vamorolone) in Canada. This agreement marks a significant milestone in Catalyst's strategic initiative to expand the product's footprint in North America.
Under the terms of the agreement, Catalyst will supply the product to Kye, which will assume full responsibility for obtaining regulatory approval for Agamree for the treatment of Duchenne Muscular Dystrophy (DMD) from Health Canada and all future aspects of commercialization of the product within Canada. Kye Pharmaceuticals Inc. will have the exclusive Canadian rights to commercialize Agamree (vamorolone) oral suspension and will be responsible for funding all regulatory, marketing, and commercialization activities in Canada.
The collaboration between Catalyst and Kye Pharmaceuticals demonstrates a sustained commitment to patient care and improving health outcomes across the U.S. and Canada. Catalyst will also provide support to Kye Pharmaceuticals in its efforts to obtain regulatory approval for the product from Health Canada.
Agamree, a novel corticosteroid designed to achieve dissociative properties while maintaining efficacy, has shown potential to demonstrate comparable efficacy to steroids with a potentially better-tolerated side effect profile. In the pivotal Vision-DMD study, Agamree met the primary endpoint time to stand (ttstand) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile.
This partnership comes on the heels of Catalyst's acquisition of the exclusive license for North America for Agamree® (vamorolone) oral suspension in 2023. Agamree previously received FDA orphan drug and fast track designations and was approved by the FDA for commercialization in the U.S. on October 26, 2023.
With this agreement, Catalyst will receive an upfront payment and be eligible to receive further reimbursement and sales milestones and sales royalties for Agamree.
The move is seen as a significant step forward in bringing innovative treatments for rare diseases, including DMD, to patients in Canada and further solidifies Catalyst's position as a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases. The market has reacted to these announcements by moving the company's shares 1.3% to a price of $17.59. Check out the company's full 8-K submission here.
