London, September 20, 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, announces the signing of an exclusive US license agreement with FAES Farma S.A. to commercialise Bilastine tablets, a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria.
20 September 2021
Product, Press Release
Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US 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.
“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 US,” said Brian Hoffmann, President of Hikma Generics. “Since its first launch in Europe in 2011, Bilastine has been successfully commercialised as a leading allergy brand in more than 100 countries. By introducing Bilastine in the US, 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 US patients.”
Bilastine is a non-sedating second generation antihistamine molecule for the treatment of allergic rhinitis and urticaria. Bilastine is currently approved in more than 120 countries and achieved more than €290 million in worldwide sales in 2020. If approved by the FDA, Bilastine would be the first New Chemical Entity antihistamine approved in the US since 2007.