Emmaus Life Sciences has entered into a licensing and exclusive distribution agreement with NeoImmuneTech (NIT) for Endari, a prescription-grade L-glutamine oral powder.
The agreement grants NIT exclusive rights to distribute, market, and sell Endari and its generic equivalents for sickle cell disease in Canada, and the US, its territories.
Under the terms of the agreement, Emmaus will receive an upfront payment and a royalty on NIT’s product sales.
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The effective date of the agreement is subject to NIT securing the required regulatory licences and approvals for the sale and distribution of Endari in the agreed regions.
Endari is indicated to reduce acute complications of sickle cell disease in adults and children aged five years and above. It is currently approved for marketing in the US, Kuwait, Bahrain, Israel, Qatar, Oman, and United Arab Emirates.
The product is also available on a named patient or early access basis in the Netherlands, France, and the Kingdom of Saudi Arabia, with an application for marketing authorisation anticipating final action by the Saudi Food & Drug Authority.
Emmaus chairman and CEO Willis Lee said: “Emmaus has continuously reassessed its commercialisation strategy to maximise global value of Endari. While the US market represents a mature and stable revenue base, we believe other regions such as the Middle East, Brazil, and Europe offer greater growth potential.”
NIT acting CEO Tae Woo Kim said: “The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialisation of an FDA-approved therapy.
“The US distribution, reimbursement, and marketing infrastructure built through Endari will also create significant synergies for the future commercialisation of our proprietary pipeline, including NT-I7.”
In July 2023, Emmaus received marketing authorisation from the Oman Ministry of Health for Endari (L-glutamine oral powder) for the treatment of sickle cell disease in patients aged five years and above.
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