Santhera enters exclusive license agreement with Sperogenix for Vamorolone in rare diseases

pharmafile | January 4, 2022 | News story | Manufacturing and Production  

Santhera Pharmaceuticals has announced that it has entered into an exclusive license agreement with China-based company, Sperogenix Therapeutics, specialising in orphan diseases. Under the terms of the agreement, Sperogenix will receive exclusive rights for development and commercialization of vamorolone for the treatment of Duchenne muscular dystrophy (DMD) and any other rare disease indications for Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

“We look forward to working with Sperogenix, a strong rare disease partner and well positioned for bringing vamorolone to patients in China,” said Dario Eklund, CEO of Santhera. “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.”

Santhera will remain responsible for manufacturing and supply. Sperogenix, a company financed by Lilly Asia Ventures and Morningside Ventures, will focus on regulatory and development work and future commercialisation. Sperogenix 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.

There are significant opportunities in the healthcare business in China due to the large patient base and high unmet needs. Regulatory reforms have led to an increasing number of approvals and launches of innovative medicines. The estimated prevalence of DMD could be as high as 70,000 patients with increasing rate of diagnosis giving more patients access to care in expert centres. There is currently no approved treatment for DMD in China.

“We are pleased to partner with Santhera. We believe in the potential of vamorolone as a treatment for Duchenne muscular dystrophy and are excited about its potential in the treatment of other rare diseases. The extensive regulatory, clinical and commercialisation experience in rare disease products of our team will help to bring this differentiated product candidate to benefit patients in the Greater China region,” said Alan (Zhiyu) Yan, Co-founder, Chairman and CEO of Sperogenix.

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