Santhera joins GENESIS Pharma in an exclusive sales association for AGAMREE® (Vamorolon) in Zentral- and Osteurope ab

Pratteln, Switzerland, September 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) has offered an exclusive sales agreement with GENESIS Pharma for AGAMREE® (Vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD) in 20 markets in Central and Eastern Europe.

Santhera Pharmaceuticals and GENESIS Pharma are a Vertriebsvereinbarung for 20 brands in Mittel- und Osteuropa eingegaan. This strategic analysis of the Soul, the uncovered medical spoilage, indem GENESIS Pharma AGAMREE in Greece, Zypern, Malta, Romania, Bulgaria, Slowenia, Croatia, Poland, the Czech Republic, Ungarn, the Slovakia, Lithuania, Latvia, Estonia, Serbia, Nordmazedonia, Bosnia and Herzegovina, Montenegro, Albania and Kosovo.

“The Vertriebsvereinbarung with GENESIS Pharma is a partner for Santhera, which is discontinuing the global sales of AGAMREE. Indem with our experts, who know the specific market knowledge of it, we ensure optimal care for the patients who are sure of it,” says Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera“It is a different story in our strategy, one of our own Santhera teams in the European market for economic and commercial partnerships with the best cooperation for the European core markets.”

Constantinos Evripides, Managing Director of GENESIS Pharmaexplained: “Our company has a sharp focus on a selective disease and is lagging behind in the marketing of orphan therapies. While this is the case, Santhera has a high quality in the CEE region and a great opportunity, a broad and robust portfolio for a select amount of money in a different way. We will work with Santhera, a reimbursement and unhindered care for all patients, who can perform innovative, profitable treatments.”

The European Commission established AGAMREE in December 2023 for the treatment of DMD in patients for 4 years. The basis for this was the data from positive DMD approval studies and more objectionable studies. Patients, who are busy with AGAMREE or placebo, look at a normal and normal guard, which happens in children, who were treated with prednisone, a guard care was observed. If patients use a standard corticosteroid on AGAMREE in patients, its effect is carried out in a safe way in your guard and in your Knochengesundheit.

About AGAMREE® (Vamorolone)
AGAMREE is a new device with a working mechanism, which acts on the binding and the dense range with short-term reductions, but it is possible that the action is changed. This is an essential substrate for the 11-β-Hydroxysteroid-Dehydrogenase (11β-HSD) Enzyme, which is responsible for the local high Active substance level and the short steroid-association toxin in local connections during the duration (1-4). By this mechanism it is possible that the action of the Sicherheitsbedenkende steroids is coupled, we will use AGAMREE as a dissociative agent and alternative to the best short steroids, of the standard therapy for children and adolescents with DMD, positioned (1-4).

In the relevant VISION-DMD study, AGAMREE achieved the first study endpoint (TTSTAND) in the placebo study (p = 0.002) after 24 studies and a clear Sicherheits and Vertraglichkeitsprofil (1, 4). Die am häufsten reportedeten Nebenwirkungen were cushingoides Aussehen, Erbrechen, Wetzunahme und Reizbarkeit. I was all involved in the Nebenwirkungen von leichtem bis mittlerem Schweregrad.

The data in question, that AGAMREE in the short steroid of the guard are not included (5) and no negative effects on the button substance exchange cap, were invested by normal serum markers for bone formation and resorption (6).

AGAMREE (Vamorolon), an Arzneimittel for seltene Krankheiten, ist in de USA (prescribing information), de European Union (Zusammenfassung der Merkmale des Arzneimittels) en in de Vereinigten Königreich voor de Anwendung Zugelassen.

Literature reference:
(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., MDA 2022 Posterpresentation. Link.

Uber Duchenne Muscular Dystrophy
The Duchenne-Muskeldystrophy (DMD) is a seltene, which is formed by the X-chromosome effect, the rapid elimination of males. DMD is a component that is used in the burt or the kurz danach auftritt. The treatment with a fibrosis of the muskeltone is clinically clinical by the enhanced musk generation and -swäche. The weight of the disease depends on the delight of the disease, the delight of self-healing, the beginning of the support of the disease and the disease of a cardiomyopathy. DMD reduces the life-threatening consequences of air and/or heart failure up to the fourth life-threatening period. Short steroids are the time standard for the treatment of DMD.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company engaged in the development and marketing of innovative drugs for neuromuscular and pulmonary medicine with a special drug. This drug provides an exclusive solution for all indications for AGAMREE® (Vamorolone), a dissociative steroid with novel synthetic drugs, which is being investigated in a specific disease trial in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard short-term steroids. AGAMREE is approved for the treatment of DMD in the US 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) in the US. Santhera has established an AGAMREE for North America, Catalyst Pharmaceuticals and China for Sperogenix Therapeutics. For more information, please visit www.santhera.com.

AGAMREE® is a Brand of Santhera Pharmaceuticals.

About GENESIS Pharma
GENESIS Pharma is a regional biopharmaceutical company, which focuses on the innovative biopharmaceutical products of the trade and the selection of diseases in Central and Eastern Europe. GENESIS Pharma has fought and fought a war in 1997 with the first pharmaceutical companies in Europe, which were engaged in Marketing, Sale and Sales of biopharmaceutical products that were specially developed. GENESIS Pharma has developed a large portfolio in therapies with a high Mediterranean character through long-term strategic alliances with a well-developed biopharmaceutical company. More information can be found at www.genesispharmagroup.com.

For more information, please read the following:
[email protected] oder
Eva Kalias, Head of Investor Relations & Communications
Phone: +41 79 875 27 80
[email protected]

For more information about GENESIS Pharma, please know:
Natalia Karahaliou, Communications Manager
[email protected]
Phone: +30 210 87 71 605

Haftungsausschluss / Zukunftsgerichtete Aussagen
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