On July 11, 2017 Cytovia Inc. ("Cytovia") the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune") reported that it has entered into a licensing agreement with Pint Pharma International S.A. ("Pint") a pharmaceutical company focused on Latin America and other markets, for the marketing and distribution of Ceplene throughout Latin America (the "territory") (Press release, Immune Pharmaceuticals, JUL 11, 2017, View Source [SID1234519793]). Pint Gmbh will separately enter into an investment agreement, which will lead to an investment of $4 million into Cytovia. Dr. Massimo Radaelli, Executive Chairman of Pint, will also join the board of Cytovia upon completion of the investment and effective spin off of Cytovia from Immune. Schedule your 30 min Free 1stOncology Demo!
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"Following the acquisition from Mylan of Ceplene rights in Europe and Asia, Cytovia is pleased to confirm the partnership with Pint for Latin America markets. This will provide Cytovia an opportunity to generate revenues from Latin American sales of Ceplene. This potential is incremental to revenues expected from European sales where Ceplene is approved in thirty countries." said Daniel Teper, of Cytovia.
"We intend to immediately initiate regulatory registration of Ceplene in the LATAM markets based on the European approval. Furthermore, Pint has extensive experience with Early Access Programs for orphan drugs and is planning to offer a similar program to AML patients who are candidates for treatment with Ceplene" added David Munoz, CEO of Pint.
Ceplene is the only drug currently approved in 30 European countries and Israel for the maintenance of first remission in Acute Myeloid Leukemia (AML). Ceplene has a reimbursed cost of therapy of approximately $25,000/year in Europe based on a full course of treatment. The addressable market for remission maintenance in AML is estimated at 7000 patients in Europe. Additionally the addressable market in Latin America is estimated at 4000 patients. There are currently no alternative drugs approved in the remission setting.
About Ceplene
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 reactive oxygen species-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 (AACR) (Free AACR Whitepaper) in 2016 confirmed the safety and efficacy of Ceplene in the international study that supported European approval.
About Acute Myeloid Leukemia (AML)
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis and typically become free of detectable leukemia, achieving "complete remission." However, within 1-2 years, the majority (75-80%) of adult patients will experience a relapse of leukemia, with a survival prognosis of 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. The prognosis following first remission is poor and there are no other effective remission therapies currently available. AML represents an orphan condition with high unmet need.