Santhera to Obtain Worldwide Rights to Vamorolone

Santhera Pharmaceuticals has signed agreements with Idorsia and ReveraGen BioPharma, making Santhera a direct license holder of vamorolone. Under the agreements, Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for all indications worldwide. The agreements create further value for Santhera through the transfer of rights for the previously excluded markets Japan and South Korea, the right to grant sublicenses and a share in the expected Priority Review Voucher. Vamorolone, a first-in-class anti-inflammatory drug candidate with a novel mode of action, is currently being investigated in the pivotal Phase 2b VISION-DMD study in patients with Duchenne muscular dystrophy (DMD) by originator ReveraGen and completion of study enrollment is expected shortly.

Under the amended terms, Santhera expects a reduction in cash outflow in the range of USD 18-24 million in the next 12-18 months. In exchange for the revised license rights, Idorsia will receive 366,667 Santhera shares and an exchangeable note in the amount of CHF 10 million and ReveraGen will receive USD 7 million, in monthly instalments of up to USD 500,000, to fund the ongoing clinical development of vamorolone.

“We are excited about the license transfer of vamorolone to Santhera. Our decision to exercise the option now has been driven by a combination of factors including the availability of encouraging clinical efficacy and safety data with vamorolone, enhanced deal terms and the ability to gain full control over the asset,” Dario Eklund, Chief Executive Officer of Santhera, said. “We look forward to contributing our significant expertise to advancing vamorolone in DMD and exploring additional business development opportunities. We believe that having two promising, complementary, late stage assets for DMD in our pipeline will enable increased access to potentially transformative treatments for a wider patient population. We are grateful to Idorsia, our anchor shareholder, for enabling early access to the license, highlighting its confidence in Santhera as the best suited company to bring vamorolone to patients.”

“We are delighted about the revised contractual arrangement and being able to work directly with Santhera as the licensee for vamorolone. Santhera’s experience in both development of DMD drug candidates and the commercialization of a rare disease product positions it well to bring vamorolone to patients. Our work to date clearly shows that vamorolone not only holds the potential to become a new standard of care for patients with DMD but also could benefit patients in a number of other inflammatory diseases,” Eric Hoffman, PhD, Vice President of Research of ReveraGen BioPharma, said.

Idorsia has assigned its original agreement with ReveraGen to Santhera. Santhera has thus become a direct contracting party with ReveraGen and with a signed early option exercise this allows Santhera to gain exclusive and immediate access to vamorolone and defers some early milestone-related payments until after study readout. Under the terms of the agreements now signed with ReveraGen and Idorsia, Santhera has obtained an exclusive license, including sublicensing rights, for vamorolone in all indications and all territories worldwide, now also including Japan and South Korea. Additionally, ReveraGen is the holder of a Rare Pediatric Disease designation, which may result in receipt of a Priority Review Voucher upon approval of vamorolone for DMD. Santhera will have a share in any revenues of a potential sale of such a voucher.