Immune Pharmaceuticals said today it has signed a letter of intent to license the lead asset of its oncology subsidiary Cytovia, the cancer treatment Ceplene® (histamine dihydrochloride), throughout Latin America to Pint Pharma.
As part of the deal, set to be finalized within 30 days, Pint has agreed to invest $4 million into Cytovia. The money will be used exclusively for oncology-related activities, the companies said.
Under the licensing agreement, Pint will oversee registration of Ceplene in Latin American countries that include Argentina, Brazil, Chile, Colombia, and Mexico. In addition to registration, Pint agreed to oversee commercialization activities for Ceplene, such as pricing and reimbursement and sales and marketing activities.
The companies’ agreement is based on the existing marketing authorization of Ceplene in Europe, where the treatment is approved for maintaining first remission in patients with acute myeloid leukemia (AML) in combination with interleukin-2 (IL-2).
Ceplene is designed to work by enhancing the immunostimulatory effect of IL-2 and countering reactive oxygen species-induced dysfunction and apoptosis of T and natural killer (NK) cells, thus inducing immune-mediated killing of leukemic cells.
According to Pint, approximately 10,000 new cases of AML are diagnosed per year in Latin America, with no treatment currently approved for the maintenance of AML remission
“Pint Pharma's desire to bring Ceplene/IL-2 immunotherapy to patients in Latin America complements our strategy,” Immune Pharma CEO Daniel Teper, Ph.D., MBA, said in a statement.
As articulated on Immune Pharma’s blog on Monday, that strategy calls for creating a global specialty immuno-oncology pharmaceutical company around Ceplene.
“Cytovia would have the opportunity, leveraging the European Medicine Agency approval, to commercialize in Latin America through a regional commercial partner,” Immune Pharma stated. “Cytovia would also pursue opportunities in other regions through strategic alliances and acquisition of complementary commercial assets. Cytovia would become a new specialty oncology pharmaceutical company with product sales and licensing revenues to fuel its growth.”
While Cytovia would focus on commercialization and late-stage development of immuno-oncology drugs, Immune Pharma would specialize in clinical proof-of-concept development for immuno-inflammation and immuno-dermatology drugs, Immune added.
Pint was established in 1993 as a spinout of the University of Austria. Initially focused on marketing prostaglandins, which it still sells under its own brand, Pint has since built a portfolio of in-licensed and internally developed drugs for oncology, rare disease, and specialty pharma indications.
Pint has direct commercial operations in Colombia, Mexico, Brazil, Venezuela, Peru, and the Dominican Republic.
“Adding Ceplene to our portfolio of products will further leverage our experience and presence in the oncology field in Latin America,” added Pint CEO David Muñoz.