Santhera Partners with Uniphar for AGAMREE Distribution in GCC

Santhera Pharmaceuticals Collaborates with Uniphar for AGAMREE® Distribution

Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) has recently announced a strategic agreement with Uniphar, granting exclusive rights for the distribution of AGAMREE® (vamorolone) in several GCC nations including the United Arab Emirates, Saudi Arabia, Kuwait, Oman, and Bahrain. This collaboration aims to facilitate the treatment of Duchenne muscular dystrophy (DMD) in patients aged four and above.

Anticipated sales of AGAMREE are set to commence on a named patient basis in the first quarter of 2026, with broader commercial availability expected by late 2026, pending authorization and pricing arrangements. Under the terms of the agreement, Santhera will earn a percentage of the net sales, consistent with their previous distribution partnerships. This significant deal underscores the commitment of both companies to ensure that patients in these regions receive timely access to this groundbreaking therapy.

Leadership Insights on the Partnership

Chief Executive Officer of Santhera, Dario Eklund, expressed enthusiasm about the alliance, stating, “Partnering with Uniphar for the distribution of AGAMREE in the GCC is thrilling. Their extensive regional reach and experience in access programs are crucial in addressing the critical need for effective treatments for DMD in this region. This agreement is a vital advancement in our global strategy, reflecting our dedication to making rare disease treatments more accessible.”

Santhera is committed to propelling the global launch of AGAMREE, which is already paving the way for patients across North America, Europe, and Asia who urgently require DMD treatment. The company continues to gather momentum as it expands its footprint in the pharmaceutical sector, aligning with partners who share the goal of improving patient outcomes.

Uniphar's Role in Enhancing Treatment Access

Brian O’Shaughnessy, Chief Commercial Officer at Uniphar, also shared his thoughts: “We are honored to collaborate with Santhera to make AGAMREE available in GCC countries. Our comprehensive knowledge of the region and commitment to increasing access to innovative therapies aligns perfectly with Santhera’s mission. Together, we aim to ensure that patients living with DMD receive prompt and effective treatment.”

Understanding AGAMREE® (Vamorolone)

AGAMREE is an innovative medication designed to bind to the same receptor as glucocorticoids, yet it modifies the downstream activity differently, significantly reducing the risk of side effects commonly associated with traditional corticosteroids. This unique mechanism of action potentially separates its efficacy from the safety concerns of steroids, positioning AGAMREE as a promising alternative in the realm of anti-inflammatory treatments for DMD.

The pivotal VISION-DMD study demonstrated that AGAMREE successfully met its primary endpoint at 24 weeks, revealing a notable improvement in Time to Stand (TTSTAND) velocity when compared to placebo, which illustrates its effectiveness in a clinical setting. The safety profile of AGAMREE has also been promising, with reported side effects typically being mild to moderate, including manageable symptoms like weight gain and irritability.

Safety and Efficacy of AGAMREE

Research indicates that AGAMREE does not exhibit the growth restrictions observed with traditional corticosteroids and shows no adverse impacts on bone metabolism, which is crucial for young patients experiencing growth and development.

This medicinal product is subject to additional monitoring to quickly identify new safety information and healthcare professionals are encouraged to report any suspected adverse reactions.

About Santhera Pharmaceuticals

Santhera Pharmaceuticals (SIX: SANN) is dedicated to developing and commercializing innovative therapies aimed at treating rare neuromuscular diseases with significant unmet medical needs. The company holds an exclusive worldwide license for AGAMREE® (vamorolone) from ReveraGen. The drug serves as a groundbreaking treatment for DMD, challenging traditional corticosteroid approaches and aligning with Santhera's mission to provide comprehensive care for patients in need.

About Uniphar

Based in Dublin, Ireland, Uniphar is a trusted partner for pharmaceutical, medtech, and biotech companies, working relentlessly to improve patient access to essential medicines globally. With over 57 years of experience, Uniphar provides a full spectrum of integrated services tailored to extend market reach and enhance patient access, creating success stories across 180 countries.

Frequently Asked Questions

What is AGAMREE used for?

AGAMREE is used to treat Duchenne muscular dystrophy (DMD) in patients aged four and older.

When will AGAMREE be available in GCC countries?

Sales are expected to begin on a named patient basis in early 2026, with broader commercial sales following later in the year.

How does AGAMREE differ from traditional corticosteroids?

AGAMREE modifies receptor activity differently than glucocorticoids, thereby reducing the typical side effects associated with corticosteroids.

What is the role of Uniphar in this collaboration?

Uniphar will manage the distribution of AGAMREE in the GCC, leveraging their regional expertise to enhance access for patients.

What are the side effects of AGAMREE?

Common side effects include weight gain, irritability, and mild cushingoid features, but they are generally of mild to moderate severity.

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