Immune Pharmaceuticals Signs Letter of Intent with Pint Pharma Regarding License and Commercializion of Ceplene ® in Latin America

NEW YORK, April 20, 2017 -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or "Immune Pharma") 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 ("Pint"), 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 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."

 

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 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.

 

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.

 

About Immune Pharmaceuticals Inc.   

 

Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory liver disease. Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology subsidiary, Cytovia, plans to develop Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc., Immune's pain and neurology subsidiary, houses AmiKet™ and AmiKet™ Nano™, pipeline products for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.

 

About Pint Pharma

 

Pint Pharma is a private, Latin American focused pharmaceutical company, devoted to the development, registration and commercialization of specialty based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care and Oncology.

 

Forward-Looking Statements    

 

This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements also include, among others, statements regarding the prospective agreement to license Ceplene and Pint Pharma's commitment and ability to bring Ceplene/IL-2 immunotherapy to patients in Latin America.These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that either party will ever enter into a definitive agreement to license Ceplene with each other or any other party, for Immune  to obtain equity financing from Pint Pharma, or that Immune will realize any of the anticipated benefits of such a transaction should it occur. Additional factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain or NanoCyclo will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAbs program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property; risks associated with the contemplated transaction with NPT. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.