Santhera Pharmaceuticals has entered agreements with Idorsia and ReveraGen BioPharma to gain exclusive global rights to Duchenne muscular dystrophy (DMD) drug, called vamorolone.
The agreements provide Santhera with a licence from ReveraGen, the originator of the drug, in all indications worldwide.
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In addition, the deals cover rights for the previously excluded Japan and South Korea markets, right to grant sub-licences and a share in the expected priority review voucher.
Under the terms of the latest agreements, Idorsia will receive 366,667 Santhera shares and an exchangeable note worth Sfr10m ($10.9m) while ReveraGen will receive $7m in monthly instalments to support the clinical development of vamorolone.
An anti-inflammatory drug candidate, vamorolone is currently being studied in the Phase IIb VISION-DMD clinical trial in DMD patients by ReveraGen.
Santhera Pharmaceuticals CEO Dario Eklund said: “We look forward to contributing our significant expertise to advancing vamorolone in DMD and exploring additional business development opportunities.
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By GlobalData“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.”
Idorsia has assigned its original deal with ReveraGen to Santhera, making Santhera a direct contracting party with ReveraGen. This provides Santhera immediate access to the drug and defers certain early milestone payments.
ReveraGen BioPharm research vice-president Eric Hoffman said: “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.”
Santhera estimates that the peak sales potential for vamorolone in the DMD indication alone would be in excess of $500m in the US and the largest five European Union markets.
In August last year, Santhera licensed a drug called Raxone, indicated for the treatment of Leber’s hereditary optic neuropathy (LHON), to Chiesi Farmaceutici (Chiesi Group).
