Turkish company to sell Duchenne MD steroid therapy Agamree
The drug will initially be available next year on a named patient basis
The steroid therapy Agamree (vamorolone), which is used for helping to preserve muscle function in people with Duchenne muscular dystrophy (DMD), will be sold and promoted in Turkey by Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN), per an agreement with Santhera Pharmaceuticals.
“As leaders in the Turkish specialty pharmaceuticals market, GEN were a natural choice for Santhera as we looked for a high-quality distribution partner,” Dario Eklund, CEO of Santhera, said in a company press release.
According to the companies, the supply and sale of Agamree in Turkey for DMD patients ages 4 and older is expected to start in the first half of 2026. The therapy will initially be available on a named patient basis, followed by wider commercial availability.
“We look forward to working closely in the run-up to launching in the country in 2026, to provide access to the many DMD patients lacking suitable treatment options,” Eklund said.
DMD features chronic damage to muscle fibers that’s driven in part by inflammation. Corticosteroids, which mimic the naturally occurring hormone cortisol, are anti-inflammatory medications that are a staple treatment for DMD to help preserve muscle function. However, traditional corticosteroids can cause side effects that are seen in people with high cortisol, such as weight gain and mood swings.
What is Agamree?
Agamree is a so-called dissociative steroid, meaning it’s designed to interact with cortisol receptors to promote the anti-inflammatory effects of traditional corticosteroids, while causing fewer side effects.
Data from a clinical trial called VISION-DMD (NCT03439670) showed Amagree preserved muscle function in DMD much the way the traditional corticosteroid prednisone does, but those given Amagree tended to report fewer side effects.
Agamree has been approved in the U.S. for DMD patients, ages 2 and older, since 2023. It’s also approved in Europe and other markets, though specific indications and age ranges may vary.
“The potential for Agamree is clear and we are determined to ensure this DMD therapy reaches patients in Türkiye without delay,” said Abidin Gülmüş, chairman and CEO of GEN. “We understand the rare disease market deeply, use our longtime experience on neuromuscular diseases and look forward to partnering with Santhera in the months and years ahead.”
Santhera owns an exclusive worldwide license from the therapy’s original developer Reveragen BioPharma to market Agamree. Per previous deals, Agamree is distributed in North America by Catalyst Pharmaceuticals and in China by Sperogenix Therapeutics.
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