Emmaus Life Sciences Grants Exclusive North American Rights for Sickle Cell Drug Endari to NeoImmuneTech
Key Insights
Emmaus Life Sciences (search) has entered into a licensing and exclusive distribution agreement with NeoImmuneTech (search) for Endari, granting exclusive rights to distribute the sickle cell disease (search) treatment in the US, its territories, and Canada.
The agreement includes an upfront payment and royalties on product sales, with the effective date contingent on NeoImmuneTech (search) securing necessary regulatory approvals and licensing.
Endari is currently approved for marketing in multiple countries including the US, Israel, Kuwait, Qatar, UAE, Bahrain and Oman, and is indicated to reduce acute complications of sickle cell disease (search) in adults and children aged five years and older.
Emmaus Life Sciences (search) has entered into a licensing and exclusive distribution agreement with NeoImmuneTech (search) (NIT) for Endari, a prescription-grade L-glutamine oral powder used to treat sickle cell disease (search). The agreement grants NIT exclusive rights to distribute, market, and sell Endari and its generic equivalents for sickle cell disease in Canada, the US, and its territories.
Financial Terms and Regulatory Requirements
Under the terms of the agreement, Emmaus will receive an upfront payment and a royalty on NIT's product sales. The effective date of the agreement is subject to NIT securing the required regulatory licenses and approvals for the sale and distribution of Endari in the agreed regions.
Current Market Presence
Endari is indicated to reduce acute complications of sickle cell disease (search) in adults and children aged five years and above. The drug 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 authorization anticipating final action by the Saudi Food & Drug Authority.
Strategic Rationale
Willis Lee, Chairman and CEO of Emmaus, explained the company's strategic shift: "Emmaus has continuously reassessed its commercialization strategy to maximize 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."
Tae Woo Kim, Acting CEO of NeoImmuneTech (search), highlighted the significance of the agreement: "The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialization of an FDA-approved therapy. The US distribution, reimbursement, and marketing infrastructure built through Endari will also create significant synergies for the future commercialization of our proprietary pipeline, including NT-I7."
About Endari and Sickle Cell Disease
Endari was approved by the U.S. Food and Drug Administration in July 2017 for treating sickle cell disease (search) in adult and pediatric patients five years of age and older. The most common adverse reactions in clinical studies included constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
There are approximately 100,000 people living with sickle cell disease (search) in the United States and millions more globally. In the United States, an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with sickle cell disease. The genetic mutation responsible for the disease causes red blood cells to distort into a sickle shape, reducing their ability to transport oxygen throughout the body and leading to incapacitating pain, tissue and organ damage, and early death.
Company Backgrounds
Emmaus Life Sciences (search) is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease (search). NeoImmuneTech (search) is a clinical-stage biopharmaceutical company specializing in T cell-based immunotherapy, with a mission to expand the potential of immuno-oncology and enhance immune responses to infectious diseases.