Santhera Enters into Supply and Distribution Agreement for AGAMREE ® (Vamorolone) with Clinigen Group By Investing.com

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Pratteln, Switzerland, January 6, 2025 “ Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with the Clinigen Group to manage the supply and distribution of AGAMREE ® (vamorolone) in countries where the product is not otherwise commercially available.

Santhera Pharmaceuticals and Clinigen Group announce that they have signed a supply and distribution agreement for AGAMREE in countries where the product is not currently commercially available through Santhera or one of its current distribution partners. The agreement will provide access to AGAMREE on a case-by-case basis for patients with Duchenne muscular dystrophy (DMD) in situations where the physician believes there are no suitable alternatives and when regulations permit. This agreement allows Santhera to receive a majority share of the revenue generated by sourcing products in these additional countries.

This distribution agreement with Clinigen, which is complementary to other previously announced partnerships and agreements, will allow Santhera to significantly increase our level of service to patients and healthcare professionals by processing individual requests for AGAMREE from areas where Santhera is not directly represented or pending negotiations with local to partners are ongoing, he said Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera.

DMD is one of the most common and devastating types of muscle degeneration, it is a progressive condition that is diagnosed in childhood and it is encouraging to be able to help healthcare professionals support appropriate patients with additional treatment options. We look forward to working with Santhera to make AGAMREE available globally to patients on an unlicensed basis in those territories where it is not currently licensed or reimbursed. This partnership demonstrates our continued commitment to accelerating access to medicines to improve the quality of life for people around the world, he said Julie Gosper, Senior Vice President, Europe and Partner Markets at Clinigen.

With the opening of this distribution channel, Santhera continues with the gradual introduction of AGAMREE in key European areas. Commercialization of AGAMREE in Germany and Austria, where the reception was very positive, started in Q1-2024. Santhera plans to launch AGAMREE in other major European markets, with the UK (including Scotland) in early 2025. The rollout will continue throughout 2025 in France, Italy, Spain and other European countries. Santhera continues to expand its partner network, which already includes multiple geographies, to bring AGAMREE to DMD patients in need of treatment.

About AGAMREE ® (vamorolone)
AGAMREE (vamorolone), an orphan drug, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics), the United States Kingdom (TADAWUL:), Mainland China and Hong Kong.

References:
[1] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
[2] Guglieri M et al. (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.
[3] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293
[4] Heier CR et al. (2019). Life Science Alliance DOI: 10.26508
[5] Ward et al., WMS 2022, FP.27 – Poster 71. Link.
[6] Hasham et al., Poster presentation MDA 2022. Link.

About Duchenne muscular dystrophy
Duchenne muscular dystrophy (DMD) is a rare X-linked inherited disease that almost exclusively affects males. DMD is characterized by inflammation that is present at birth or shortly thereafter. Inflammation leads to muscle fibrosis and is clinically manifested by progressive muscle degeneration and weakness. The main milestones in the disease are the loss of the ability to move, the loss of independent feeding, the start of assisted ventilation and the development of cardiomyopathy. DMD reduces life expectancy before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for DMD.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical needs. The company holds an exclusive license from ReveraGen for all indications worldwide for AGAMREE ® (vamorolone), a dissociative steroid with a novel mode of action, which has been tested 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 US by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) , in China by the National Medical (TASE:) Products Authority (NMPA) and Hong Kong by the Department of Health (DoH). Santhera has out-licensed rights to AGAMREE for North America Catalyst Pharmaceuticals (NASDAQ:), and for China and certain countries in Southeast Asia Sperogenix Therapeutics. For further information, visit www.santhera.com.

AGAMREE ® is a trademark of Santhera Pharmaceuticals.

For additional information, please contact:
public-relations@santhera.com or
Andrew Smith, Chief Financial Officer
andrew.smith@santhera.com

About Clinigen
Clinigen is a global specialty 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 world. The group supports pharmaceutical and biotechnology companies throughout the life cycle of medical products, from clinical to commercial, and operates from locations in North America, Europe, Africa and the Asia-Pacific region. Clinigen has more than 1,100 employees on five continents in 15 countries and provides access to more than 130 countries each year. For more information about Clinigen, visit http://www.clinigen.com.

Disclaimer / Looking to the future
This communication does not constitute an offer or invitation to subscribe or purchase securities Santhera Pharmaceuticals Holding (SIX:) AG. This publication may contain certain forward-looking statements regarding the company and its operations. Such statements involve certain risks, uncertainties and other factors that could cause the Company’s actual results, financial condition, performance or achievements to differ materially from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

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