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 Dr. 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."