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Agreements

Date: 2016-01-04

Type of information: Licensing agreement

Compound: nano-capsule formulation of cyclosporine A

Company: Immune Pharmaceuticals (USA - MA, Israel) Yissum (Israel) BioNanoSim (Israel)

Therapeutic area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases

Type agreement:

licensing

Action mechanism:

immunosuppressive agent

Disease: atopic dermatitis, psoriasis

Details:

* On January 4, 2016, Immune Pharmaceuticals announced that following the review of new efficacy data, it has entered into an exclusive worldwide licensing and development agreement with BioNanoSim, an Israeli nanotechnology drug delivery company, for a novel topical nano-capsule formulation of cyclosporine. BioNanoSim has been 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. 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. 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.

* On June 10, 2015, Immune Pharmaceuticals announced that it has entered into a binding Memorandum of Understanding with Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem regarding the worldwide exclusive licensing and development of a topical, biodegradable, nano-capsule formulation of cyclosporine A. Cyclosporine A, when administered systemically (Sandimmune®, Neoral®), is an effective treatment for psoriasis, atopic dermatitis, pemphigus vulgaris and other severe inflammatory dermatoses. The topical nano-capsule technology and the application to cyclosporine A have been developed by the team of Professor Simon Benita, former Director of the Institute for Drug Research and Dean of the School of Pharmacy at the Hebrew University of Jerusalem. Professor Benita pioneered an ocular nano-formulation of cyclosporine A, approved for marketing in Europe for the treatment of severe keratitis associated with dry eye disease. Professor Benita commented: \"We succeeded in incorporating cyclosporine A into biodegradable nano-capsules and have developed stable topical formulations able to achieve therapeutic cyclosporine A levels in the targeted skin layers. Cyclosporine A nano-capsule therapeutic effect was confirmed in two different animal models, which we believe may support a potential topical alternative to oral cyclosporine A, and to other topical immuno-suppressive drugs.

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