GENESIS Pharma announces an exclusive distribution agreement with Santhera Pharmaceuticals to commercialize vamorolone in 20 markets in Central and Eastern Europe
GENESIS Pharma announces an exclusive distribution agreement with Santhera Pharmaceuticals (SIX: SANN) for vamorolone, indicated for the treatment of Duchenne muscular dystrophy (DMD), in 20 markets in Central and Eastern Europe. This strategic collaboration aims to address unmet medical needs by allowing GENESIS Pharma to commercialize vamorolone in Greece, Cyprus, Malta, Romania, Bulgaria, Slovenia, Croatia, Poland, Czech Republic, Hungary, Slovakia, Lithuania, Latvia, Estonia, Serbia, North Macedonia, Bosnia & Herzegovina, Montenegro, Albania, and Kosovo.
The European Commission approved vamorolone for the treatment of DMD, in patients 4 years of age and older, in December 2023.
“This distribution agreement with GENESIS Pharma marks a significant achievement for Santhera as we expand the global availability of vamorolone. By partnering with expert organizations with a strong understanding of specialist markets, we ensure optimal patient access,” said Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera. “This is a further step in our strategy to allow focus on key European markets with dedicated Santhera teams while partnering with the best companies for non-core European markets.”
Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “Our company has a strong focus on rare diseases and an established expertise of more than twenty years in the commercialization of orphan therapies. We are delighted that Santhera has trusted our capabilities across the CEE region, giving us the opportunity to add vamorolone to our broad and robust orphans’ portfolio. We will work closely and diligently with Santhera to ensure a smooth and unhindered access to all patients that can benefit from this innovative treatment.”
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.
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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 vamorolonen, 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. Vamorolonen 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.
The product’s trademark is registered by Santhera Pharmaceuticals.
For more information, please contact:
public-relations@santhera.com or
Eva Kalias, Head Investor Relations & Communications
Phone: +41 79 875 27 80
eva.kalias@santhera.com
About GENESIS Pharma
GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com και www.genesispharmargoup.com.
For more information, please contact:
Natalia Karahaliou, Communications Manager
nkarahaliou@genesispharma.com
+30 210 87 71 605
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
