Hikma, FAES Farma ink licensing agreement for Bilastine

Hikma has signed an exclusive U.S. license agreement with FAES Farma to commercialize Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria.

Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the Food and Drug Administration and for the commercialization of the product in the United States following approval. Hikma will provide FAES with an upfront payment, regulatory approval and commercial milestone payments as well as royalties. The agreement builds upon Hikma and FAES Farma’s existing partnership on Bilastine in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries.

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“We are pleased to form this partnership with FAES Farma for Bilastine, which builds on our growing position in the allergy market and further advances our objective of strengthening our specialty business in the U.S.,” said Brian Hoffmann, president of Hikma Generics.

Hoffmann added, “Since its first launch in Europe in 2011, Bilastine has been successfully commercialized as a leading allergy brand in more than 100 countries. By introducing Bilastine in the United States, Hikma is further solidifying its presence in the allergy market, and we will leverage our existing salesforce promoting our specialty portfolio, including our partnership with Eyevance Pharmaceuticals for the co-promotion of Zerviate and our forthcoming branded seasonal allergic rhinitis nasal spray Ryaltris. We look forward to bringing this new treatment option to U.S. patients.”