BUSINESS INSIGHTS

Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US

Hikma Pharmaceuticals PLC | September 21, 2021

Hikma and FAES Farma enter into exclusive licensing agreement for the commercialisation of Bilastine tablets in the US
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.

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. 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.

- Brian Hoffmann, President of Hikma Generics.

About Bilastine
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.

About Hikma
Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world.

Spotlight

We designed this guide in order to explain how the pharmaceutical industry in Ukraine functions — an innovative, dynamic, non-monopolized industry that creates high value-added products. Over the past three years, this industry has made significant progress: companies have received European manufacturing certificates, the intensity of investment remains one of the highest among other industries, while investment itself is increasing. The structure of the market also changes, the share of prescription and high-priced medicines increases, while the overall market volume is growing


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