Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE (Vamorolone) in the United States

• AGAMREE is U.S. FDA approved and now available in the United States for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older
• This follows the first commercial launch of AGAMREE in Germany in January 2024 by Santhera
• AGAMREE is the first DMD treatment approved across the U.S., EU and UK

Pratteln, Switzerland, March 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) is pleased to note the launch of AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States (U.S.) by Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), the Company’s commercialization partner for North America.

“Congratulations to our partner Catalyst on the launch of AGAMREE in the United States. Following the first global market introduction of this novel product in Germany in January, this launch represents an important next step in making AGAMREE available to as many patients with DMD as soon as possible,” said Dario Eklund, CEO of Santhera.

The launch of AGAMREE in the U.S. follows the approval of the product by the U.S. Food and Drug Administration (FDA) on October 26, 2023, based on data from the pivotal VISION-DMD study, recently published in Neurology, and supplemented with safety information collected from three open-label studies, including extension studies.

According to the license agreement between the companies, first announced in June 2023, Catalyst holds an exclusive North American license to commercialize AGAMREE for DMD and all potential future indications. Under the agreement, Catalyst will pay Santhera sales-based milestones of up to USD 105 million as well as up to low-teen percentage royalties and will assume Santhera's corresponding third-party royalty obligations on AGAMREE sales in all indications in North America.

Read more in Catalyst’s announcement here.

About AGAMREE (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4].