Santhera Partners with GENESIS Pharma for AGAMREE® Distribution

Santhera Pharmaceuticals Establishes Strategic Partnership

Santhera Pharmaceuticals (SIX: SANN) recently took a significant step in enhancing the availability of AGAMREE® (vamorolone), a novel treatment for Duchenne muscular dystrophy (DMD). In a landmark move, Santhera entered into an exclusive distribution agreement with GENESIS Pharma aimed at expanding the distribution of AGAMREE across 20 markets in Central and Eastern Europe.

Collaboration to Meet Critical Patient Needs

This collaboration with GENESIS Pharma is not just a business agreement; it represents a deep commitment to addressing the unmet medical needs of DMD patients. By leveraging GENESIS Pharma's expertise in the region, Santhera will provide improved access to AGAMREE in countries such as Greece, Cyprus, Malta, and several others in Central and Eastern Europe.

Strategic Vision for Patient Access

“This distribution agreement marks a significant achievement for Santhera as we expand the global availability of AGAMREE,” stated Geert Jan van Daal, MD, PhD, Chief Commercial Officer of Santhera. He emphasized the importance of collaborating with specialized organizations to optimize patient reach and provided insight into Santhera's broader strategy, which focuses on key European markets while partnering with adept companies for non-core markets.

GENESIS Pharma's Commitment

Constantinos Evripides, Managing Director of GENESIS Pharma, expressed enthusiasm about the partnership, highlighting their long-standing expertise in handling rare diseases and orphan therapies. With over two decades of experience, GENESIS Pharma aims to ensure seamless access to AGAMREE for all patients who can benefit from this innovative treatment.

Approval and Clinical Insights on AGAMREE

The European Commission's approval of AGAMREE for DMD treatment for patients aged 4 and older in December 2023 underscores the drug's potential. The approval was based on significant data from pivotal and open-label studies demonstrating that AGAMREE offered comparable growth outcomes to placebo, whereas prednisone typically stunted growth in children.

Innovative Mechanism of Action

AGAMREE operates differently from conventional corticosteroids, presenting a unique mechanism that allows it to bind to glucocorticoid receptors but modifies the downstream activity. This revolutionary approach offers the promise of cortisol safety while managing inflammation effectively.

Promising Results from Clinical Trials

In clinical studies, specifically the VISION-DMD trial, AGAMREE met its primary endpoint, showing a statistically significant improvement in the Time to Stand (TTSTAND) velocity compared to placebo. Reports indicate that side effects were predominantly mild to moderate, emphasizing AGAMREE's good safety profile.

Growth and Bone Health Under AGAMREE

A crucial finding from the studies is that AGAMREE did not restrict growth or negatively impact bone metabolism, distinguishing it from traditional corticosteroid treatments. This makes AGAMREE an appealing option for families coping with DMD, as it addresses critical health concerns while promoting growth.

Understanding Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a serious, inherited condition that primarily affects males and leads to severe muscle degeneration and weakness. Symptoms often begin early in life, progressing to significant health challenges over time. Current standard treatments have limitations, making innovative solutions like AGAMREE all the more vital for improving patient outcomes.

Santhera's Mission and Future Directions

Santhera continues to pursue its mission to provide transformative therapeutics for rare neuromuscular and pulmonary diseases. As part of this mission, AGAMREE, an orphan medicinal product, is already approved in the United States and the European Union. The agreement with GENESIS Pharma is a key part of Santhera's larger strategy to ensure that patients across Europe gain access to this critical therapy as part of their treatment journey for DMD.

A Bright Future for DMD Patients

With impending partnerships and innovative drug development, patients suffering from DMD can look forward to a better quality of life, backed by the commitment of leading pharmaceutical companies dedicated to finding solutions to rare diseases.

Frequently Asked Questions

What is AGAMREE® used for?

AGAMREE® (vamorolone) is primarily used for treating Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.

What are the benefits of AGAMREE® compared to corticosteroids?

AGAMREE offers similar efficacy without the growth restrictions and negative side effects commonly associated with standard corticosteroid treatments.

Which regions will benefit from the new distribution agreement?

The distribution agreement will enhance the availability of AGAMREE in 20 Central and Eastern European markets, including countries like Greece, Cyprus, and Poland.

Who are the key players in this partnership?

Santhera Pharmaceuticals and GENESIS Pharma are the key players in this alliance focused on increasing access to AGAMREE.

How does AGAMREE® work?

AGAMREE acts on glucocorticoid receptors, modulating their activity to provide anti-inflammatory effects while minimizing safety concerns associated with traditional steroids.

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