Emmaus Shifts Focus, Licenses Sickle Cell Drug Endari to NeoImmuneTech

TORRANCE, CA – December 30, 2025 – Emmaus Life Sciences, Inc., the biopharmaceutical firm behind the sickle cell disease treatment Endari®, announced a significant strategic shift today, granting NeoImmuneTech, Inc. an exclusive license to market and distribute the drug in the United States and Canada. The deal, which includes an upfront payment and future royalties for Emmaus, marks a pivotal move for both companies, realigning Emmaus's commercial focus toward international markets while providing NeoImmuneTech with a turnkey entry into the competitive North American pharmaceutical landscape.

Under the terms of the agreement, NeoImmuneTech (NIT) will take over all marketing, sales, and distribution for Endari® (prescription grade L-glutamine oral powder) and its generic equivalents for treating sickle cell disease. The deal's finalization is contingent on NIT securing the necessary regulatory approvals and licenses, a process both parties hope to conclude, with a termination clause set for October 1, 2026, if conditions are not met.

A Strategic Pivot to Global Growth

For Emmaus Life Sciences, the decision to license its flagship product in its home market represents a calculated pivot away from the high overhead of direct U.S. commercialization toward what it sees as more fertile ground for growth abroad. The company has been navigating an increasingly competitive environment, including the market entry of generic L-glutamine alternatives following the expiration of Endari's U.S. marketing exclusivity in July 2024.

“Emmaus has continuously reassessed its commercialization strategy to maximize global value of Endari®,” commented Willis Lee, Chairman and Chief Executive Officer 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.”

This transaction effectively de-risks the company's North American operations. In exchange for direct sales revenue, Emmaus secures an upfront payment and an ongoing stream of royalties from NIT's sales. Furthermore, Emmaus will act as the exclusive supplier of Endari® to NIT for the territory, manufacturing the drug at its production cost plus an agreed-upon margin. This royalty-and-supply model provides a more predictable, lower-cost revenue stream, a crucial consideration given the company's previously reported financial pressures and liquidity risks.

Emmaus's focus on international expansion is already well underway. The company has made significant inroads in the Middle East and North Africa (MENA), securing marketing authorizations for Endari® in the United Arab Emirates, Qatar, Kuwait, Bahrain, and Oman. It also holds market exclusivity in Saudi Arabia, where an estimated 225,000 sickle cell patients reside, and is available on an early access basis in parts of Europe. This deal allows Emmaus to redirect capital and resources to accelerate these global commercialization efforts.

NeoImmuneTech's Calculated Entry into Commercialization

For NeoImmuneTech, a clinical-stage biopharmaceutical company focused on T cell-based immunotherapies, the agreement is a transformative step. It provides the South Korean firm with an immediate commercial foothold in the world's largest pharmaceutical market with an established, FDA-approved product. This move allows NIT to bypass the lengthy and costly process of building a commercial operation from scratch.

“The completion of this definitive agreement is highly meaningful, as it establishes a foundation for direct commercialization of an FDA-approved therapy,” said Tae Woo Kim, Acting Chief Executive Officer of NeoImmuneTech. He emphasized that the infrastructure built for Endari® would be invaluable for the company’s future ambitions.

NIT’s strategy is clear: use Endari® to build a robust U.S. distribution, reimbursement, and marketing apparatus. This established infrastructure will then create “significant synergies for the future commercialization of our proprietary pipeline, including NT-I7,” a T cell amplifier being investigated for immuno-oncology and infectious diseases. To ensure a smooth transition and retain market expertise, selected members of Emmaus's existing U.S. sales force will be transferred to NIT, providing crucial continuity for healthcare providers and patients.

To protect its investment, Emmaus has included a clause requiring NIT to meet specified minimum annual sales targets to maintain its exclusive rights, ensuring a dedicated commercial effort behind the drug.

The Evolving Landscape of Sickle Cell Treatment

Endari® was approved by the FDA in 2017, becoming the first new treatment for sickle cell disease (SCD) in nearly two decades. The oral powder is indicated to reduce the acute complications of the debilitating genetic disorder, which affects approximately 100,000 people in the U.S. and millions worldwide. It offered a new option for patients who could not tolerate or did not respond adequately to hydroxyurea, the long-standing standard of care.

However, the SCD treatment landscape has evolved dramatically since Endari’s launch. It now competes with other branded therapies like crizanlizumab and voxelotor, both approved in 2019. More profoundly, late 2023 saw the landmark FDA approval of two potentially curative gene therapies, Casgevy and Lyfgenia. While these one-time treatments represent a monumental leap forward, their astronomical price tags—$2.2 million for Casgevy and $3.1 million for Lyfgenia—and complex administration logistics will likely limit their use to a small fraction of eligible patients in the near term.

This reality ensures that more accessible and affordable daily therapies like Endari® will remain a vital part of the treatment paradigm for the vast majority of SCD patients. The challenge for NIT will be to effectively position Endari® within this increasingly complex and stratified market, especially with the added pressure of generic competition.

Implications for Patients and Providers

The most immediate question for the sickle cell community is what this transition will mean for patient access and support. Emmaus had previously established programs to ease the burden on patients, including co-payment assistance and a support program offering low-cost or free access for uninsured or underinsured individuals. It also launched a telehealth service to facilitate remote consultations and home delivery.

Despite these efforts, studies have highlighted persistent barriers to Endari® access, including high rates of insurance denials and prohibitive deductibles, which led to significant numbers of patients never starting or discontinuing therapy. The success of this new partnership will largely depend on NeoImmuneTech's ability to navigate these existing reimbursement hurdles while maintaining—or enhancing—the patient support systems previously in place.

The transfer of experienced sales personnel from Emmaus to NIT is a promising sign for maintaining continuity in physician relationships and clinical support. However, the onus will be on NIT to manage a seamless transition, ensuring that healthcare providers and their patients experience no disruption in the supply chain or support services as the distribution of this important therapy changes hands.