Santhera and GEN Join Forces for AGAMREE® Distribution in Türkiye
Santhera Pharmaceuticals Partners with GEN in Türkiye
Pratteln, Switzerland - Santhera Pharmaceuticals (SIX: SANN) has made a significant stride in patient care by securing an exclusive agreement with Gen ?laç ve Sa?l?k Ürünleri San. ve Tic. A.?. (GEN). The partnership focuses on the distribution and promotion of AGAMREE® (vamorolone) in Türkiye, specifically targeting treatment options for Duchenne muscular dystrophy (DMD) in patients aged four and up.
The collaborative efforts are set to initiate supply and sales in the first half of 2026, initially commencing on a named patient basis before transitioning into broader commercial sales. Santhera will benefit from an upfront payment along with a continuous share of net sales, highlighting a mutually beneficial arrangement for both parties.
Dario Eklund, the Chief Executive Officer of Santhera, expressed excitement about this partnership: "Choosing GEN as our distribution partner was natural given their established reputation in the Turkish specialty pharmaceuticals market. We are eager to work collaboratively towards launching AGAMREE in Türkiye in 2026, ensuring that DMD patients have access to essential treatment options that are currently lacking."
Abidin Gülmü?, Chairman/CEO of GEN, shared similar enthusiasm: "The potential of AGAMREE is immense, and our priority is clear: to facilitate timely access to this crucial therapy for DMD patients in Türkiye. Our deep understanding of the rare disease market and experience with neuromuscular disorders position us well for this partnership with Santhera."
Understanding AGAMREE® (vamorolone)
AGAMREE is an innovative therapeutic option that operates by interacting with the same receptors as traditional glucocorticoids, but with a unique mechanism that modifies its downstream activity. Notably, AGAMREE is not affected by the 11-?-hydroxysteroid dehydrogenase (11?-HSD) enzymes, which can lead to adverse reactions typically associated with corticosteroids. This unique profile allows AGAMREE to distinguish efficacy from the safety concerns commonly linked to steroid treatments, making it a promising alternative for existing corticosteroids that are currently the standard surgical treatment for children and adolescents with DMD.
In the pivotal VISION-DMD study, AGAMREE demonstrated a significant effect at the 24-week mark, notably achieving its primary endpoint of Time to Stand (TTSTAND) velocity when compared to placebo (p=0.002). The drug exhibited a favorable safety and tolerability profile, with the most reported side effects being mild to moderate, including cushingoid features, vomiting, weight gain, and irritability.
Importantly, current data suggests that AGAMREE avoids some of the common growth restrictions associated with corticosteroids and does not negatively impact bone metabolism, evidenced by normal serum markers for bone formation and resorption.
This medication is under continuous monitoring to swiftly identify any new safety information. Healthcare professionals are encouraged to report any suspected adverse reactions.
About Santhera Pharmaceuticals
Santhera Pharmaceuticals (SIX: SANN) is a specialized Swiss pharmaceutical firm dedicated to developing and marketing innovative therapies for rare neuromuscular diseases. The company holds an exclusive license for all global indications related to AGAMREE® (vamorolone), which has been studied as an alternative to traditional corticosteroids for DMD. AGAMREE has received approvals from various regulatory bodies including the FDA in the U.S., the EMA in the EU, the MHRA in the UK, and the NMPA in China, emphasizing its global significance in treating DMD.
For further inquiries, please visit www.santhera.com.
About GEN
Gen ?laç ve Sa?l?k Ürünleri San. ve Tic. A.?. (BIST: GENIL.IS) stands as Türkiye's premier specialty pharmaceutical entity, devoted to advancing innovative treatments across various therapeutic areas, including neuromuscular conditions such as DMD and spinal muscular atrophy (SMA) since its inception in 1998. GEN is recognized for producing high-quality products at its GMP-certified facility and engages actively in original drug development through two specialized R&D centers.
For additional information, visit www.genilac.com.tr.
Contact Information
Santhera Pharmaceuticals
Catherine Isted, Chief Financial Officer: IR@santhera.com
GEN Pharmaceutical Company Contacts
Deniz Karagulle, Chief Commercial Officer: d.karagulle@genilac.com
Bulutay Gunes, Senior Head of Corporate Brand: b.gunes@genilac.com
Ali Ketencioglu, Investor Relations Manager: a.ketencioglu@genilac.com
Frequently Asked Questions
What is AGAMREE® and its primary use?
AGAMREE® is a novel medication designed to treat Duchenne muscular dystrophy (DMD) by offering a safer alternative to traditional corticosteroids.
When is AGAMREE® expected to be available in Türkiye?
Santhera reports that sales by GEN for AGAMREE® are anticipated to begin in the first half of 2026.
Who is responsible for the distribution of AGAMREE® in Türkiye?
The exclusive distribution of AGAMREE® in Türkiye will be managed by GEN ?laç ve Sa?l?k Ürünleri San. ve Tic. A.?. (GEN).
What advantages does AGAMREE® offer over corticosteroids?
AGAMREE® has shown a unique mechanism that minimizes common side effects associated with corticosteroids, particularly avoiding growth restrictions and preserving bone metabolism.
How can I find more information on Santhera or GEN?
For more details, you can visit Santhera's website at www.santhera.com or GEN's website at www.genilac.com.tr.
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