AGAMREE to Treat DMD in Canada Through Catalyst-Kye Partnership

A license, supply, and commercialisation agreement has been reached between Catalyst Pharmaceuticals Inc., a commercial-stage biopharmaceutical company that specialises in in-licensing, developing, and commercialising novel medicines for patients with rare and difficult-to-treat diseases, and Kye Pharmaceuticals Inc., giving Kye the exclusive right to commercialise AGAMREE (vamorolone), a novel corticosteroid for the treatment of Duchenne Muscular Dystrophy (DMD) and possibly other indications.

As per the agreement, Catalyst will provide the medicine to Kye, which will take full responsibility for securing regulatory clearance from Health Canada for AGAMREE for the treatment of DMD and for all subsequent elements of the product's commercialisation inside Canada. In Canada, Kye is already selling Catalyst's main medication for Lambert Eaton myasthenic syndrome, FIRDAPSE.

"We are happy to sign this deal with Kye Pharmaceuticals for AGAMREE, which represents a significant step forward in our strategic plan to increase the product's market share in North America. Richard J. Daly, CEO and President of Catalyst, said, "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." "We are excited to collaborate closely with our partner, who will lead the regulatory approval process for AGAMREE. It is our goal to submit the application to Health Canada by the beginning of 2025."

"Our extended cooperation with Catalyst demonstrates the inherent value of our joint effort to improve health outcomes in the United States and Canada by working together to find novel medicines for rare illnesses, such as DMD. As a team, we are dedicated to providing innovative treatments and closing important gaps in clinical care', said Kye Pharmaceuticals CEO and President John McKendry.

As per the agreement, Kye Pharmaceuticals, Inc. will be in charge of financing all regulatory, marketing, and commercialisation initiatives in Canada and will have the only Canadian rights to market AGAMREE (vamorolone) oral suspension.In addition to supporting Kye Pharmaceuticals in its attempts to secure regulatory clearance for the medicine from Health Canada, Catalyst will handle clinical and commercial supplies.

Catalyst will be paid in advance and may earn further reimbursement, sales milestones, and sales royalty for AGAMREE, provided that the terms and conditions outlined in the License, Supply, and Commercialisation Agreement are met.