Immune Pharmaceuticals Announces New Data with Topical Cyclosporine Nano-Capsules in Dermatology

NEW YORK, Jan. 4, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP), "Immune", a clinical-stage biopharmaceutical company, announced today that following the review of new efficacy data, it has entered into an exclusive worldwide licensing and development agreement with BioNanoSim Ltd ("BioNanoSim"), an Israeli nanotechnology drug delivery company, for a novel topical nano-capsule formulation of cyclosporine (also known as "cyclosporine-A" or "CsA").

Monica Luchi, M.D., Chief Medical Officer of Immune, commented: "Oral cyclosporine, a potent immunosuppressive drug, known to reduce the activity of the immune system by interfering with T-cells, has revolutionized transplantation medicine. Its use in dermatology has been limited to severe cases of psoriasis and atopic dermatitis, because of significant systemic toxicity. In a validated human skin model of atopic dermatitis, a novel topical nano-capsule formulation of cyclosporine A demonstrated comparable efficacy to a high potency topical corticosteroid. We believe that this product candidate could provide an important therapeutic alternative for millions of patients with chronic inflammatory skin disorders such as moderate atopic dermatitis and psoriasis. We intend to accelerate the development of this product candidate under the abbreviated 505(b)(2) drug development pathway permitted by the U.S. Food and Drug Administration."

This topical nano-capsule formulation of cyclosporine incorporates a patented technology invented by Professor Simon Benita, the former Director of the Institute for Drug Research and Head of the School of Pharmacy at the Hebrew University of Jerusalem. Professor Benita has pioneered a nano-drug delivery platform for improving the absorption of poorly absorbed drugs. He recently succeeded in incorporating cyclosporine into a nano-capsule formulation that can be absorbed through the skin.  In validated preclinical animal and human skin models, this new topical formulation was shown to deliver therapeutic levels of cyclosporine to targeted skin layers and to limit systemic absorption. "We believe that this collaboration with Immune will leverage our nanotechnology expertise and advance this novel product candidate into the clinic," said Professor Benita.

"This product candidate -topical cyclosporine nano-capsules- builds on Immune's focused Immuno-dermatology franchise. Bertilimumab, our clinical stage monoclonal antibody is currently in phase II for the treatment of bullous pemphigoid, an orphan auto-immune skin disorder, and will be further developed for severe atopic dermatitis" said Dr. Daniel Teper, Immune's CEO.

Under terms of the agreement, Immune will fund further development of the product candidate and BioNanoSim will be eligible to potentially receive certain development and regulatory milestones as well as royalties on sales. BioNanoSim is a nanotechnology drug delivery company formed by Professor Simon Benita, and Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem. Immune previously signed a Memorandum of Understanding with Yissum regarding the application of the technology.

About Immune Pharmaceuticals:

Immune Pharmaceuticals (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 auto-immune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and 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 pipeline includes, bispecific antibodies, nanotherapeutics, including NanomAbs®, and several mid-to-late stage small molecules. Immune's non-core pipeline includes AmiKet™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com, the content of which is not a part of this press release.

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SOURCE Immune Pharmaceuticals, Inc.

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