Emmaus to sell North American rights to sickle cell treatment Endari
Neoimmunetech will gain license to market, sell treatment in U.S., Canada
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Emmaus Life Sciences has entered into an agreement to sell the North American rights to Endari (oral L-glutamine), its oral treatment to prevent acute complications related to sickle cell disease (SCD), to Neoimmunetech.
Under the agreement, Neoimmunetech will receive an exclusive license to all rights for marketing, selling, and distributing Endari and any generic equivalents in the U.S., its territories, and Canada.
In exchange, Emmaus will get an upfront payment as well as royalties on sales. The agreement’s effective date is subject to Neoimmunetech securing all necessary regulatory approvals and licenses.
“The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialization of an FDA-approved therapy,” Tae Woo Kim, acting CEO of Neoimmunetech, said in a press release from Emmaus. The FDA, or U.S. Food and Drug Administration, approved Endari for SCD in 2017.
Endari designed to reduce type of cell damage
SCD is a genetic disorder marked by the production of an abnormal form of hemoglobin, the protein that red blood cells use to carry oxygen. This faulty hemoglobin is prone to clumping in red blood cells, causing them to acquire a sickle shape that marks them for destruction and can block small blood vessels. This can block blood flow, leading to acute complications such as painful vaso-occlusive crises.
Endari, administered in the form of an oral powder, is designed to reduce oxidative stress, a type of cell damage that is increased in sickled red blood cells of SCD patients and contributes to disease activity.
In the U.S., it’s been approved to reduce severe SCD-related complications in patients ages 5 and older. The approval was primarily based on data from a year-long Phase 3 clinical trial (NCT01179217) that evaluated the therapy against a placebo in SCD patients as young as 5 years old. Results showed that the therapy significantly reduced rates of pain crises and hospitalizations.
“Emmaus has continuously reassessed its commercialization strategy to maximize global value of Endari,” said Willis Lee, chairman and CEO of Emmaus. “While the U.S. market represents a mature and stable revenue base, we believe other regions such as the Middle East, Brazil, and Europe offer greater growth potential.”
Outside the U.S., Endari has been approved in some Middle East countries, including Qatar, the United Arab Emirates, and Oman. It is currently being reviewed for approval in Saudi Arabia.
Emmaus had applied for the therapy’s approval in the European Union, where it would have been sold under the name Xyndari, but withdrew its application in 2019 after an advisory committee recommended against approval. Endari is not currently approved in Canada or in Brazil.
