PPMD has learned that Santhera Pharmaceuticals has entered into an agreement granting exclusive North America license for vamorolone to Catalyst Pharmaceuticals. Santhera will continue to keep commercialization rights in Europe, while Catalyst will obtain commercialization rights in the U.S., Canada, and Mexico.
Vamorolone in an investigational dissociative steroid for individuals with Duchenne. A new drug application (NDA) for vamorolone in DMD is under review in the U.S. by FDA with a Prescription Drug User Fee Act (PDUFA) date for its regulatory decision on approval set for October 26, 2023. We will continue to share updates with the community as we learn more about this partnership and the regulatory decision for vamorolone.
Read the community letter from Santhera:
Dear Duchenne Community,
We are writing to provide some additional information to accompany our press release issued today about the announcement of an agreement for vamorolone with Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX).
As the press release states, Santhera has entered into an exclusive licensing and collaboration agreement for vamorolone in Duchenne muscular dystrophy (DMD) and all future indications in North America (NA) with Catalyst Pharmaceuticals, Inc. This collaboration agreement provides Catalyst with commercialization rights to vamorolone in DMD and to all potential additional indications in North America, comprising the U.S., Canada, and Mexico. At closing of the deal, Santhera will obtain upfront payments and is eligible for future milestones in addition to royalty payments. Most importantly, this partnership will ensure that patients and families will have access to vamorolone for DMD, once approved, as rapidly as possible following launch in both the US and around the globe.
We have chosen to partner with Catalyst due to their passion and expertise in commercialization of medicines to treat rare diseases. They currently market two medicines in the US, for Epilepsy and a rare neuromuscular condition called LEMS. Over the coming months, Santhera and Catalyst will work closely together to ensure a smooth transition with minimal disruption to ongoing projects and plans for launch.
We encourage you to read the attached press release for more details about the partnership, the overall strategy for Santhera moving forward and commercialization plans outside the U.S.
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 honor 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 firstname.lastname@example.org.