Santhera Pharmaceuticals has signed an exclusive agreement with Ikris Pharma Network to distrubute Agamree (vamorolone) in India, targeting the treatment of Duchenne muscular dystrophy (DMD) in those aged four years and above.

The five-year agreement aligns with Santhera's previous distribution deals, entitling the company to a portion of the net sales.

The sales of the drug to the Indian market will commence in the fourth quarter of 2025, beginning with a named patient programme.

Santhera Pharmaceuticals CEO Dario Eklund stated: “We are pleased to partner with Ikris Pharma Network in India, which is part of our wider strategy to increase global access to Agamree for patients with DMD.

“Ikris has been actively working in the area of DMD, and their expertise and dedication to ensuring rare disease drugs reach patients make them an ideal partner in the region.”

The collaboration is part of Santhera's ongoing efforts to extend Agamree's reach globally, building on recent distribution agreements in Turkey and Gulf Cooperation Council nations.

Ikris Pharma Network CEO and founder Praveen Sikri stated: “This collaboration with Santhera aligns with our focus of addressing unmet medical needs in the rare disease community.

“We look forward to leveraging our distribution network to help DMD patients in India access this life-changing treatment.”

According to Santhera, in the VISION-DMD trial, Agamree achieved its primary endpoint by improving the time to stand velocity compared to a placebo at the 24-week mark, while also exhibiting a good tolerability and safety profile.

The most common side effects included cushingoid features, weight gain, irritability and vomiting.

Agamree has shown no adverse effects on growth or bone metabolism, a notable distinction from conventional corticosteroids, which can negatively impact these areas.

In 2024, Agamree secured approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of DMD.