Santhera Partners with Clinigen for AGAMREE® Distribution

Santhera's Strategic Agreement with Clinigen Group

Santhera Pharmaceuticals has entered into a significant partnership with Clinigen Group, aiming to facilitate the supply and distribution of AGAMREE® (vamorolone) in markets where it is not currently available. This exclusive agreement marks a pivotal moment for both organizations as they strive to increase access to this vital medication for patients with Duchenne muscular dystrophy (DMD).

Improved Access for Duchenne Muscular Dystrophy Patients

The collaboration aims to ensure that AGAMREE can be accessed on a case-by-case basis, particularly for patients deemed suitable by their physicians. This initiative is crucial for those who have no other treatment alternatives available. The agreement allows Santhera to benefit financially, securing a majority of the revenue generated from additional countries where AGAMREE is dispensed.

Supporting Patients and Healthcare Professionals

Geert Jan van Daal, MD, PhD, and Chief Commercial Officer of Santhera, expressed enthusiasm about the partnership, stating that it complements existing collaborations. He highlighted how the agreement would enhance the service provided to both patients and healthcare professionals by expediting the processing of individual requests for AGAMREE in regions where Santhera is not currently represented. This step signifies a deeper commitment to patient care.

Clinigen's Role in Broader Access

Julie Gosper, Senior Vice President, Europe and Partner Markets at Clinigen, emphasized the importance of this distribution agreement. She remarked that DMD is a progressive condition, typically diagnosed in childhood, and having the ability to support healthcare professionals in offering additional treatment options is gratifying. The partnership aims to provide AGAMREE to patients globally, especially in territories where it remains unlicensed or lacks reimbursement.

Ongoing Rollout of AGAMREE in Europe

Beyond establishing this new distribution channel, Santhera is actively rolling out AGAMREE in key markets throughout Europe. The commercialization in countries like Germany and Austria, which commenced in early 2024, has shown positive reception. Santhera intends to introduce AGAMREE to other major European markets, including the UK, by early 2025, with plans to extend throughout France, Italy, Spain, and more countries during the year. This expansion reflects Santhera's commitment to reach DMD patients who require urgent treatment.

Understanding AGAMREE® (vamorolone)

AGAMREE® (vamorolone) is recognized as an orphan medicinal product and has gained regulatory approval in various regions across the globe, including the U.S. and Europe. Its innovative approach provides an alternative treatment for DMD patients, targeting the muscle degeneration associated with the disease.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a rare genetic disorder that predominantly affects males. The condition leads to inflammation and progressive muscle deterioration, ultimately affecting mobility and quality of life. Early detection and intervention are essential, as DMD can significantly reduce life expectancy due to complications like respiratory and cardiac failure. Current standard treatments involve corticosteroids, which AGAMREE aims to complement.

About Santhera Pharmaceuticals

Santhera Pharmaceuticals is a Swiss biotech firm focused on developing innovative treatments for rare neuromuscular diseases. With a unique license for AGAMREE® and a commitment to addressing high unmet medical needs, the company plays a crucial role in the pharmaceutical landscape. Their collaboration with Clinigen is a strategic move to enhance the distribution and access of AGAMREE.

Frequently Asked Questions

What is AGAMREE® (vamorolone)?

AGAMREE is an orphan medicinal product approved for treating Duchenne muscular dystrophy, offering a novel approach compared to traditional treatments.

How does the Santhera and Clinigen partnership benefit patients?

The partnership improves access to AGAMREE in regions where it is not otherwise available, providing patients with essential treatment options.

What does the rollout plan for AGAMREE include?

Santhera plans to launch AGAMREE in major European markets throughout 2025, starting with the UK and extending to France, Italy, and Spain.

Why is early intervention important in DMD?

Early intervention can help manage symptoms and potentially prolong quality of life, delaying the progression of muscle degeneration associated with DMD.

What is the focus of Santhera Pharmaceuticals?

Santhera Pharmaceuticals focuses on developing and commercializing innovative treatments for rare neuromuscular diseases, significantly impacting patient care.

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