To become a direct license holder of vamorolone, Santhera Pharmaceuticals announced that it has moved into agreements with Idorsia and ReveraGen BioPharma Inc. Following the agreements, Santhera has now an exclusive license obtained from ReveraGen. These licenses are regarding the originator of vamorolone for the authority indications worldwide.
Santhera will attain further value because of agreement by transfering the rights for Japan and South Korea markets, the markets that were previously excluded. Japan and South Korea markets will get the right to grant sublicenses and show up in the Priority Review Voucher. It will also surface the path to partnering in additional indications.
Vamorolone is a anti-inflammatory drug candidate which is first in its categaoy and comes with a novel mode of action. It is currently under investigation in the pivotal Phase 2b VISION-DMD study in the Duchenne muscular dystrophy (DMD) patients by the originator of the drug ReveraGen while the study enrollment is expected to complete shortly.
Santhera antcipated that there will be a reduction in cash outflow to the range of USD 18-24 million following the amended terms during the next 12-18 months time period. Idorsia is projected to get Santhera’s 366,667 shares and an exchangeable note of CHF 10 million ammount in the substitute to the giving revised license rights. ReveraGen will also receive USD 7 million in the form of monthly instalments amounting up to USD 500,000, for the purpose of funding the ongoing vamorolone clinical development.
Santhera CEO, Dario Eklund said, “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.”
ReveraGen BioPharma’s Vice President of Research, Eric Hoffman said: “We are delighted about the revised contractual arrangement and being able to work directly with Santhera as the licensee for vamorolone.”
While Idorsia has assigned its agreement to Santhera which was signed earlier with ReveraGen.