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Santhera: Exclusive North America License for Vamorolone to Catalyst Pharmaceutical

June 20, 2023

Santhera has entered into an exclusive licensing and collaboration agreement for vamorolone in Duchenne muscular dystrophy and all future indications in North America with Catalyst Pharmaceuticals. This collaboration agreement provides Catalyst with commercialization rights to vamorolone for Duchenne and to all potential additional indications in North America, comprising the U.S., Canada, and Mexico.

“Duchenne muscular dystrophy is a devastating condition. Everyone at Santhera has been working diligently to advance vamorolone in order to make this important treatment option available to patients. We believe Catalyst is well placed to maximize the value of vamorolone and, subject to regulatory approval, ensure patients in North America receive this transformational therapy as quickly as possible. Catalyst has a track record of success in the rare disease and neuromuscular space and is our commercial partner of choice for North America with an established infrastructure and commitment to patients. With our new partner, we also look forward to jointly addressing the benefits of vamorolone in additional indications. As part of this agreement, Santhera benefits from upfront, milestone and royalty payments which allows us to focus on the commercial roll-out of vamorolone in DMD and future other indications in Europe.”

Dario Eklund, Chief Executive Officer of Santhera

“We want to take this opportunity to thank all of the patients and families who participated in the vamorolone clinical studies, and who have supported Santhera over the years. It has been a distinct honour for us to learn from and engage with Patient Advocacy Groups in NA, and we are deeply grateful for your collaboration. We are confident that the strong relationships today will continue with the team at Catalyst, whom you will meet in the near future. If you have any questions, please do not hesitate to contact Santhera’s Patient Advocacy Consultant, Mindy Cameron, at [email protected].”

Mindy Cameron, Patient Advocacy Consultant at Santhera

Defeat Duchenne Canada has funded the research and development of vamorolone, an anti-inflammatory therapy currently under investigation for Duchenne muscular dystrophy, that has shown promising benefits with a better safety profile than traditional corticosteroids.

We will continue to follow the progress of this agreement and look forward to sharing the news from the United States regarding the Food and Drug Administration’s (FDA) decision regarding vamorolone approval, expected October 26, 2023.

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