Santhera Enters Key Distribution Agreement for AGAMREE® in Russia

Santhera Pharmaceuticals Collaborates with Biomedica for AGAMREE® Distribution

Santhera Pharmaceuticals has made a significant leap in expanding the availability of AGAMREE® (vamorolone) by signing an exclusive distribution agreement with Biomedica. This partnership aims to provide access to this groundbreaking treatment for Duchenne muscular dystrophy (DMD) in Russia, tailored for patients aged four years and older. The collaborative effort emphasizes the need for innovative therapies in regions with substantial unmet health needs.

Details of the Distribution Agreement

As part of this agreement, Santhera will benefit through a percentage of net sales generated from AGAMREE's distribution. Sales are anticipated to kick off in the first quarter of 2026, providing new hope to the roughly 1,400 DMD patients currently living in Russia. The partnership not only ensures access to AGAMREE through various managed access programs but also enhances the support network for patients and their families.

Dario Eklund, the CEO of Santhera, articulated optimism regarding the agreement, stating, "This collaboration will significantly improve access to vital DMD treatment for children. It is one of several global agreements we have secured this year, and we anticipate a fruitful relationship with Biomedica in the coming months." Such collaborations are essential for companies like Santhera, aiming to reach a broader audience and deliver innovative solutions to rare diseases.

Biomedica's Role in the Collaboration

Biomedica, known for its expertise in neurology and rare diseases, will play a crucial role in distributing AGAMREE. Oleg Parosin, Biomedica's CEO, expressed confidence in their ability to ensure timely access to AGAMREE for patients. His assertion reflects the company’s commitment to leveraging its deep understanding of the therapeutic landscape to optimize patient outcomes in Russia.

Understanding AGAMREE® (vamorolone)

AGAMREE represents a novel approach to treating DMD, functioning as a dissociative steroid with unique mechanisms that differentiate it from traditional corticosteroids. Researchers indicate that AGAMREE interacts with the same receptor as glucocorticoids while modifying the receptor's activity to mitigate potential side effects commonly associated with steroid treatments. This significant difference positions AGAMREE as an innovative choice for managing DMD without the common drawbacks of corticosteroids.

Clinical Evidence Supporting AGAMREE

The efficacy of AGAMREE has been highlighted in clinical studies, notably the pivotal VISION-DMD trial. This study established that AGAMREE significantly improves the 'Time to Stand' (TTSTAND) velocity when compared with placebo, marking it as a promising alternative for DMD patients facing mobility challenges. The results showed that AGAMREE has a good safety profile; most adverse effects reported were mild to moderate. Unlike traditional corticosteroids, initial data suggest AGAMREE does not restrict growth or adversely impact bone metabolism, a considerable benefit for pediatric patients.

AGAMREE's Regulatory Status

AGAMREE has gained substantial recognition and approval across various markets, including the U.S., EU, UK, China, Hong Kong, and Canada. This regulatory success underscores the drug's therapeutic promise and Santhera's dedication to providing effective alternatives for patients suffering from DMD. The strategic licensing agreements with companies like Catalyst Pharmaceuticals and Sperogenix Therapeutics denote a focused effort to maximize AGAMREE's reach and availability in key markets.

Santhera's Mission and Vision

At the core of Santhera Pharmaceuticals’ mission is a commitment to developing innovative therapies for rare neuromuscular diseases, where there remains a high unmet medical need. With AGAMREE as a pivotal part of their portfolio, Santhera is actively working to change the landscape for DMD treatments worldwide. Their collaboration endeavors reflect a broader strategy to enhance patient care and access to groundbreaking therapies.

Biomedica's Expertise in Rare Diseases

Biomedica, with its deep roots in Central and Eastern Europe and beyond, specializes in commercializing therapies for rare diseases. Their collaborations with innovative biotech and pharmaceutical companies amplify their impact on providing new treatments to underserved populations. Biomedica's established market access strategies and dedication to addressing unmet medical needs position them as a formidable partner for Santhera in Russia.

Frequently Asked Questions

What is the purpose of the agreement between Santhera and Biomedica?

The agreement facilitates the distribution of AGAMREE® in Russia, improving access to this innovative treatment for Duchenne muscular dystrophy.

When are sales of AGAMREE expected to start?

Sales are anticipated to begin in the first quarter of 2026, marking a crucial milestone for patient access.

What makes AGAMREE different from traditional corticosteroids?

AGAMREE is a dissociative steroid that modifies receptor activity, aiming to reduce the adverse effects typically associated with corticosteroid use.

How does AGAMREE impact young patients with DMD?

Clinical studies indicate AGAMREE may provide effective management for DMD without negatively impacting growth or bone health.

What is Santhera's primary focus as a pharmaceutical company?

Santhera specializes in developing innovative medicines for rare neuromuscular diseases, specifically targeting high unmet medical needs.

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