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news.Immune Pharmaceuticals has signed an agreement with Mylan company Meda to repurchase assets relating to Ceplene, including the right to commercialize it in Europe and to register and commercialize in several other countries.
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Immune sold certain of these Ceplene-related assets to Meda AB in 2012. Immune intends, through its Immuno-Oncology subsidary, Cytovia, Inc. ('Cytovia') to undertake commercialization efforts in Europe, Asia and Latin America. In addition, Cytovia intends to pursue continued development of Ceplene towards potential regulatory approval in the United States.
"We are excited to regain Ceplene's European and Asian rights from Mylan and to transition Immune, through Cytovia, into a revenue-generating phase of the company's evolution. This agreement is an additional step forward towards our previously stated objective of executing a plan to establish an independent oncology business through Cytovia and follows the execution of the Letter of Intent with Pint Pharma related to licensing Ceplene in Latin America and investing in Cytovia," said Dr. Daniel Teper.
"Proactive maintenance treatment for Acute Myeloid Leukemia (AML) has been recognized as highly essential for relapse prevention, and we are pleased for the potential opportunity to become a leader in the AML remission maintenance space."
The assets acquired from Mylan include rights to marketing authorizations, trademarks, patents, and other intellectual property related to Ceplene and its use. Under the terms of the acquisition agreement, Immune has agreed to pay Mylan a fixed price, which is payable in installments, as well as additional amounts contingent on the achievement of certain milestones.
The market for AML therapeutics is steadily growing due to an aging population and medical need that has been unmet due to the complexity of AML.
Unfortunately, most patients with AML who are able to achieve complete remission will eventually relapse, and survival following such a relapse is poor, with rates of 33% in younger patients but only 15-20% in patients over 60 years of age.
In the therapeutic management of patients with AML, remission maintenance therapy is important for the prevention of relapse and the prolongation of disease-free survival.