Santhera Grants North America License For Vamorolone To Catalyst Pharma

(RTTNews) - Santhera Pharmaceuticals said that it has signed a license and collaboration agreement for vamorolone in North America with Catalyst Pharmaceuticals Inc. (CPRX). Total consideration to Santhera is up to $231 million, plus royalty payments from product sales, with near-term cash proceeds for Santhera of $126 million.

As per the terms of the agreement, Santhera will grant Catalyst exclusive commercialization rights to vamorolone in North America, comprising the U.S., Canada and Mexico.

Santhera said it will receive $90 million upfront at closing ($75 million in cash and $15 million equity investment), an additional $10 million upon U.S. FDA approval of vamorolone in Duchenne muscular dystrophy or DMD plus $ 26 million to pay approval related regulatory milestones to third parties, and potential sales milestones of up to $105 million.

The agreement covers commercialization of vamorolone in DMD and rights to all potential future indications in North America.

Catalyst noted that it will pay Santhera up to low-teen percentage royalties and will assume corresponding third-party royalty obligations on vamorolone sales in North America.

Santhera said it will continue to focus on European commercialization of vamorolone in Duchenne muscular dystrophy, and further development of its clinical pipeline.

Santhera and Catalyst intend to collaborate on joint clinical development and funding of vamorolone for additional indications beyond DMD.