Clinigen partners with Santhera Pharmaceuticals to expand access to treatment for Duchenne Muscular Dystrophy (DMD) patients

Clinigen, the global pharmaceutical services company, today announces it has signed an exclusive supply and distribution agreement with Santhera Pharmaceuticals (SIX: SANN) to provide AGAMREE® (Vamorolone) for Duchenne muscular dystrophy patients in countries where the product is not otherwise commercially available / product cannot currently be commercially obtained via Santhera or one of its current distribution partners. This partnership furthers Clinigen’s mission of accelerating access to medicines for patients worldwide.

The partnership is possible following the European Commission’s approval of AGAMREE for the treatment of DMD, in patients 4 years of age and older in December 2023, based on data from Santhera’s pivotal VISION-DMD study and three open-label studies.

This collaboration is a part of Clinigen’s objective to provide patients access to orphan drugs and other treatments that are approved for their condition but not commercially available in their region. By partnering with Clinigen’s product access and commercialisation teams pharmaceutical and biotech companies can navigate demand and facilitate access outside the global commercial roll-out. This partnership gives clinicians caring for DMD patients a new additional treatment pathway option.

Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera comments: “This distribution agreement with Clinigen, which is complementary to other, earlier announced, partnerships and agreements, will allow Santhera to significantly increase our service level to healthcare professionals through individual requests for AGAMREE from geographies in which Santhera is not directly represented or while negotiations with local partners are ongoing. Partnering with Clinigen will supercharge our efforts to get this DMD treatment option into the hands of patients who really need it”.

Senior Vice President, Europe and Partner Markets at Clinigen, Julie Gosper, comments: “DMD is one of the most common and devastating types of muscular degeneration, it is a progressive condition diagnosed in childhood and it is encouraging to be able to help healthcare professionals support appropriate patients with an additional treatment option. We look forward to working with Santhera to make AGAMREE available globally on an unlicensed basis in those territories where it is not currently licensed or reimbursed. This partnership demonstrates our ongoing commitment to accelerate access to medicines, to improve the quality of people’s lives around the world.”