Clinigen partners with Santhera Pharmaceuticals to expand access to treatment for Duchenne Muscular Dystrophy (DMD) patients
LONDON, UK, 6 January 2025: 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."
Clinigen’s experienced Partnering teams and operations in Europe, Japan, Asia Pacific and Africa have unrivalled global reach and local expertise built up over 35 years of partnering with pharmaceutical and biotechnology companies. They provide a full-service affiliate-like commercialisation and distribution partnership model to take the complexity out of access and offer a seamless and efficient path to market. Clinigen supports access from development through to commercialisation, holding 100+ products under exclusive unlicensed distribution, supporting 300+ active managed access programmes and holding 400+ product licenses globally.
Contact details
C: Fight or Flight on behalf of Clinigen
E: : clinigen@fightorflight.com
Notes to Editors
About Clinigen
Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 15 countries and provides access in more than 130 countries every year.
For more information on Clinigen, please visit http://www.clinigengroup.com.
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to vamorolone for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com.
AGAMREE® is a trademark of Santhera Pharmaceuticals.
About AGAMREE® (vamorolone)
AGAMREE (vamorolone), an orphan medicinal product, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics) and the United Kingdom.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD.