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

Rhea-AI Summary

Hikma Pharmaceuticals PLC has announced an exclusive US license agreement with FAES Farma S.A. to commercialize Bilastine tablets, an antihistamine for allergic rhinitis and urticaria. Hikma will obtain FDA regulatory approval and handle commercialization upon approval, providing upfront and milestone payments along with royalties to FAES. This partnership builds on an existing collaboration in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries, aiming to enhance its presence in the US allergy market.

Positive

• Exclusive US licensing agreement for Bilastine enhances Hikma's portfolio in the allergy market.
• Bilastine has over €290 million in global sales and is approved in more than 120 countries, indicating strong market potential.
• The agreement signifies a strategic advancement in Hikma's specialty business in the US.

Negative

• Regulatory approval from the FDA is still pending, introducing uncertainty before commercialization.
• The initial upfront payment and milestone payments could impact short-term cash reserves.

LONDON, Sept. 20, 2021 /PRNewswire/ -- 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," 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."

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.

Enquiries      

Hikma Pharmaceuticals PLC          

Susan Ringdal EVP, Strategic Planning and Global Affairs	+44 (0)20 7399 2760/ +44 7776 477050 uk-investors@hikma.uk.com
Steve Weiss David Belian US Communications and Public Affairs	+1 732 788 8279 +1 848 254 4875 uscommunications@hikma.com

About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/stable Fitch)

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. For more information, please visit: www.hikma.com

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SOURCE Hikma Pharmaceuticals USA Inc.

FAQ

What is Hikma's new agreement regarding Bilastine in the US?

Hikma has signed an exclusive US license agreement with FAES Farma to commercialize Bilastine tablets for allergic rhinitis and urticaria.

What are the financial implications of the Bilastine agreement for Hikma?

Hikma will provide upfront and milestone payments to FAES, which could impact its short-term cash flow.

In how many countries is Bilastine currently approved?

Bilastine is approved in over 120 countries worldwide.

What is the significance of the FDA approval for Bilastine?

If approved, Bilastine would be the first new chemical entity antihistamine approved in the US since 2007.

What is Hikma's strategy with this licensing agreement?

Hikma aims to strengthen its position in the US allergy market and expand its specialty business.