Immune Acquires Worldwide Rights
Accelerates Development for the Treatment
of Psoriasis and Atopic Dermatitis
Los Angeles, January 14, 2106 - StockWatchIndex (SWI) announced today that Immune Pharmaceutical, a clinical-stage biopharmaceutical company, after reviewing new efficacy data for a novel topical nano-capsule formulation of cyclosporine, has acquired worldwide development and licensing rights for the treatment of Psoriasis and Atopic Dermatitis.
As we had reported only a few days ago, in 2015, Immune made important progress with its lead drug candidate, Bertilimumab, receiving clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application, which allowed the company to include U.S. patients in its Phase II clinical trial in bullous pemphigoid, an orphan auto-immune disease of the skin.
Following the review of new efficacy data, Immune has now entered into an exclusive worldwide licensing and development agreement with BioNanoSim Ltd, an Israeli nanotechnology drug delivery company, for a novel topical nano-capsule formulation of cyclosporine, also known as "cyclosporine-A" or "CsA".
According to the Chief Medical Officer of Immune, Monica Luchi, M.D., Oral cyclosporine is a potent immunosuppressive drug, known to reduce the activity of the immune system by interfering with T-cells and 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. Immune believes 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. The company intends 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.
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 believes that the collaboration with Immune will leverage his nanotechnology expertise and advance this novel product candidate into the clinic. This topical nano-capsule formulation of cyclosporine incorporates a patented technology invented by Professor Benita, who has pioneered a nano-drug delivery platform for improving the absorption of poorly absorbed drugs. This product candidate -topical cyclosporine nano-capsules- builds on Immune's focused Immuno-dermatology franchise.
For the text of the full company press release, please visit http://immunepharmaceuticals.investorroom.com. For further information contact Immune Pharmaceuticals Inc., Anna Baran, Director, Corporate Affairs, Tel: 646-561-8010, firstname.lastname@example.org
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We reiterate that the advancement in Immune's product development, the FDA's approval for the Investigational New Drug (IND) application, the acquisition of the worldwide rights for the Treatment of Psoriasis and Atopic Dermatitis, the company's plans for the expansion of its clinical trial centers and the engagement of a new, highly experienced management team should result in reaching the mile stones that Immune has set for itself for 2016 and that investors expect.
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