Generex Biotechnology signed a letter of intent to acquire a controlling 51% interest in Emmaus Life Sciences for $225 million in cash and shares. Emmaus’s lead product, an orally administered pharmaceutical-grade L-glutamine (PGLG) product for the treatment of sickle cell disease (SCD), is under FDA review, with a PDUFA date of July 7, 2017. Emmaus says it will have the opportunity to earn back 36% of its capital stock, out of the 51% interest sold to Generex, upon achieving certain milestones. 

Generex separately confirmed that it had closed its previously reported deal to acquire 51% of infectious disease in vitro diagnostics (IVD) developer Hema Diagnostic Systems. The $15 million share-based deal for Hema was originally announced back in 2015.

Emmaus is focused on the development of treatments for rare and orphan diseases. The PGLG therapy has been granted orphan drug designation in the U.S. and Orphan Medicinal Product designation in the EU. Reporting on the PDUFA data back in November 2016, Emmaus also confirmed plans to submit a marketing authorization application to the European Medicines Agency. The firm says that Generex is working toward rebuilding its company, with a plan toward up-listing to a major stock exchange. 

Commenting on the deal with Generex, Yutaka Niihara, M.D., M.P.H., Emmaus CEO, stated: “It is with great anticipation that we have forged this relationship with Generex, setting the stage for great successes for both companies and their stockholders…. Emmaus and Generex will collaborate to rebuild Generex as well as to grow Emmaus in a synergistic fashion.” Joseph Moscato, Generex president and CEO, added, “We at Generex very much look forward to working with Dr. Niihara and his team at Emmaus. Our objective will be to help Emmaus build on the solid scientific successes it has already enjoyed with a view to achieving myriad product commercializations.”

The L-glutamine product for SCD represents Emmaus’s flagship product. The firm is separately working with Tokyo-based CellSeed to jointly develop and commercialize the U.S. CellSeed’s regenerative autologous corneal epithelial sheet technology for restoring vision in patients with limbal stem cell deficiency. The technology has previously been evaluated in European clinical studies.