Immune Pharmaceuticals signs letter of intent with Pint Pharma regarding license and commercialization of Ceplene in Latin America.
Immune Pharmaceuticals Inc. announced today that it has entered into a letter of intent with Pint Pharma GmnH, a pharmaceutical company focused on Latin America and other markets, which binds the parties to seek agreement regarding an exclusive license by Pint of the rights to commercialize Ceplene throughout Latin America, including Argentina, Brazil, Chile, Colombia and Mexico. Immune and Pint target closing a final agreement within 30 days.
Pursuant to the anticipated final agreement, Pint will be responsible for registration of Ceplene in Latin American countries based on the existing European marketing authorization and will carry out the full commercialization of the licensed product in the territory, including Ceplene registration, pricing and reimbursement, and sales and marketing activities.
In conjunction with the anticipated final agreement, Pint will make an investment of $4 million into Immune Pharma’s oncology subsidiary, Cytovia, Inc. to be used by Cytovia exclusively for oncology related activities.
Ceplene has been approved in Europe for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML) in combination with interleukin-2 (IL-2). According to Pint, there are approximately 10,000 new cases of AML diagnosed per year in Latin America and there is currently no approved treatment for the maintenance of AML remission.
“We are excited about the possibility of partnering with Pint Pharma, a market leader in Latin America with strong commercialization capabilities in the field of oncology. Pint Pharma’s desire to bring Ceplene/IL-2 immunotherapy to patients in Latin America complements our strategy,” said Dr. Daniel Teper, CEO of Immune.
“Adding Ceplene to our portfolio of products will further leverage our experience and presence in the oncology field in Latin America,” said David Munoz, Chief Executive Office at Pint. “We are delighted to potentially have Immune as a committed partner to help strengthen our product portfolio.”
Dr. Massimo Radaelli, Executive Chairman of Pint Pharma, has served as an independent director of Ariad Pharmaceuticals Inc. until 2016. He has held the position of President and CEO of Dompe International SA and previously held senior executive positions at Roche, Menarini and DuPont Merck.
“We are very enthusiastic about this potential partnership with Immune and Cytovia which is developing much needed therapies in oncology,” said Radaelli. “We believe we can leverage the high unmet need for relapse preventive immunotherapy to potentially accelerate the registration and commercial availability of Ceplene in Latin America for patients suffering from AML.”
Ceplene (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). It has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment.
Ceplene acts by enhancing the immunostimulatory effect of IL-2 and countering ROS-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 confirmed the safety and efficacy of Ceplene in the international study that supported European approval.
(Source: PR Newswire)