Santhera Partners with Ikris for AGAMREE® Distribution
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) has recently formed a pivotal agreement with Ikris Pharma Network to distribute AGAMREE® (vamorolone) in India. This exclusive partnership is dedicated to providing a treatment option for Duchenne muscular dystrophy (DMD) in children four years and older.
Details of the Distribution Agreement
The collaboration extends for a five-year term, during which Santhera expects to benefit from a percentage of net sales, which aligns with their practices from previous distribution agreements. The product is anticipated to hit the market by the last quarter of 2025, available initially on a named patient basis.
This agreement builds on Santhera's commitment to expanding AGAMREE's availability from its recent successes in Turkey and several Gulf Cooperation Council countries. The aim is to facilitate widespread access to AGAMREE across diverse markets worldwide.
Leadership Insights
Dario Eklund, the CEO of Santhera, expressed his enthusiasm for the partnership, stating, “Teaming up with Ikris in India represents our broader strategy to enhance global patient access to AGAMREE. Ikris's experience in the field of DMD, coupled with their unwavering dedication to ensuring vital treatments reach patients, positions them as the perfect collaborator for us.”
Praveen Sikri, the founder and CEO of Ikris Pharma Network, echoed this sentiment, highlighting the importance of addressing the urgent medical needs within the rare disease sector, saying, “Our collaboration with Santhera aligns perfectly with our mission to provide access to crucial medications for rare diseases. We are committed to leveraging our distribution network to ensure that patients with DMD can access this significant treatment.”
Understanding AGAMREE® (vamorolone)
AGAMREE is a novel therapeutic that offers a unique mechanism of action by interacting with glucocorticoid receptors while differentiating its effects from traditional steroid treatments. This innovative approach potentially allows AGAMREE to minimize some of the common side effects associated with corticosteroids, particularly those affecting growth and bone metabolism.
In clinical trials, particularly the pivotal VISION-DMD study, AGAMREE demonstrated significant efficacy in improving the ability to stand, outperforming placebo treatments while maintaining a favorable safety profile. Despite some mild to moderate side effects such as weight gain and irritability, AGAMREE does not restrict growth or adversely influence bone metabolism, a notable advantage over standard corticosteroid therapies.
Regulatory Status and Future Plans
Currently, AGAMREE holds approvals across multiple global markets, including the United States, European Union, and parts of Asia. Santhera's strategy includes licensing agreements in North America and specific Southeast Asian territories, facilitating an extensive outreach to patients worldwide.
Challenges of Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscle degeneration, commonly diagnosed in early childhood. Without a curative approach, the primary treatment options have historically been corticosteroids and supportive care, which can only manage symptoms rather than halt progression.
By introducing AGAMREE into the treatment landscape in India, Santhera and Ikris Pharma aim to offer new hope to patients and families affected by DMD. Their collaboration is focused on addressing both access to medication and raising awareness for resources needed in managing this challenging condition.
Company Contacts
For further inquiries, please contact:
Santhera Pharmaceuticals
Catherine Isted, Chief Financial Officer: IR@santhera.com
ICR Healthcare: Santhera@icrhealthcare.com
Ikris Pharma Network
Praveen Sikri, Chief Executive Officer: info@ikrispharmanetwork.com
Bharat Sikri, Global Project Manager: Raredisease@ikrispharmanetwork.com
Frequently Asked Questions
1. What is AGAMREE®?
AGAMREE® (vamorolone) is a novel medication designed to treat Duchenne muscular dystrophy (DMD), offering an alternative to traditional corticosteroids.
2. What are the expected benefits of AGAMREE®?
AGAMREE® aims to provide effective treatment while minimizing common side effects related to growth and bone health, which are often seen with corticosteroids.
3. How will the partnership with Ikris enhance access to treatment in India?
Ikris Pharma Network specializes in rare disease logistics; their partnership with Santhera ensures that AGAMREE® reaches patients in India who need it most.
4. When will AGAMREE® be available in India?
Sales of AGAMREE® are set to start by late 2025, initially available for named patients.
5. Why is the collaboration between Santhera and Ikris significant?
This partnership represents a critical step in increasing the availability of vital treatments for DMD in India, addressing unmet medical needs effectively.
