Swiss company Santhera Pharmaceuticals (SPHDF.OB), said on Tuesday that it has signed a $124-million license agreement with Sperogenix Therapeutics, a Chinese firm specializing in orphan diseases, for Vamorolone, a drug used for the treatment of Duchenne muscular dystrophy or DMD.
Santhera will receive an upfront cash compensation and DMD-related American-regulatory milestone payments totaling $20 million, as well as further double-digit royalties on net sales.
Dario Eklund, Chief Executive Officer of Santhera, commented: "…This agreement enables us to continue our focus on US and EU regulatory activities on our own while also gaining access to one of the largest pharmaceutical markets globally."
Under the terms of the deal, Santhera will grant Sperogenix with exclusive development and commercialization rights for Vamorolone in DMD and all other rare disease indications for China. This includes mainland China, Hong Kong, Macau, and Taiwan.
The Swiss firm will make and supply the drug, while Sperogenix, will focus on regulatory and development work and future commercialization.
Lilly Asia Ventures and Morningside Ventures backed Chinese drug maker plans to initiate a regulatory filing for Vamorolone for DMD in China upon US FDA approval which could lead to market entry in China as early as in 2024.
Santhera estimates the peak product sales potential for Vamorolone in the indication DMD alone to be in excess of $500 million in the U.S. and the largest five European countries combined.
The estimated prevalence of DMD in China could be as high as 70,000 patients with increasing rate of diagnosis giving more patients access to care in expert centers. There is currently no approved treatment for DMD in China, Santhera said in a statement.
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