Defeat Duchenne Canada is pleased to share this update from Catalyst Pharmaceuticals with our Canadian Duchenne community. We will continue to communicate with Catalyst Pharmaceuticals and Kye Pharmaceuticals and will share any additional information as it becomes available.

Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it has entered into a License, Supply, and Commercialization Agreement with Kye Pharmaceuticals Inc., (“Kye” or “Kye Pharmaceuticals”) granting Kye the exclusive Canadian commercial rights to AGAMREE^® (vamorolone), a novel corticosteroid for the treatment of Duchenne Muscular Dystrophy (“DMD”) and potentially other indications. 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 DMD from Health Canada and all future aspects of commercialization of the product within Canada. Kye currently markets FIRDAPSE^®, Catalyst’s flagship product for the treatment of Lambert Eaton myasthenic syndrome, in Canada.

“We are pleased to enter into this agreement with Kye Pharmaceuticals for AGAMREE, marking a pivotal milestone in our strategic initiative to expand the product’s footprint in North America. This collaboration leverages our combined expertise, fortifies our alliance by licensing our second therapeutic rare disease product for Canada, and demonstrates our sustained commitment to patient care.”

“Building upon the U.S. approval of AGAMREE, we are committed to helping facilitate access to this novel corticosteroid treatment to DMD patients and their healthcare providers in Canada. We look forward to working closely with our partner, who will spearhead the regulatory approval process for AGAMREE, with application submission to Health Canada anticipated by early 2025.”

Richard J. Daly, CEO and President of Catalyst

“Our expanded partnership with Catalyst highlights the intrinsic value of our collaboration in developing innovative treatments for rare diseases, including DMD, and exemplifies our shared dedication to improving health outcomes across the U.S. and Canada. Together, we are committed to delivering novel therapies and bridging clinically significant treatment gaps.”

John McKendry, CEO and President of Kye Pharmaceuticals.

Under the terms of the agreement, 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. Catalyst will be responsible for clinical and commercial supply and provide support to Kye Pharmaceuticals in its efforts to obtain regulatory approval for the product from Health Canada. Subject to the satisfaction of terms and conditions set forth in the License, Supply, and Commercialization Agreement, Catalyst will receive an upfront payment and be eligible to receive further reimbursement and sales milestones and sales royalties for AGAMREE.

Read the full press release below.