# Hikma Pharmaceuticals sign exclusive US license agreement to commercialise Ryaltris

- Link: https://www.directorstalkinterviews.com/hikma-pharmaceuticals-sign-exclusive-us-license-agreement-to-commercialise-ryaltris/412806704
- Published: 2020-02-27T07:45:38+00:00
- Author: Amilia Stone

**[Hikma Pharmaceuticals PLC](https://www.directorstalkinterviews.com/ftse-company/hikma-pharmaceuticals/hik.l)**(
LON:HIK), the multinational generic pharmaceutical company, and Glenmark Specialty
S.A., a Swiss subsidiary of Glenmark Pharmaceuticals, a global innovative pharmaceutical
company, today announced the signing of an exclusive US license agreement to commercialise
Ryaltris™ (olopatadine hydrochloride and mometasone furoate nasal spray), an investigational
fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis(
SAR).

Under the terms of the agreement, Glenmark will be responsible for the continued
development and regulatory approval of Ryaltris™ by the US Food and Drug Administration(
FDA). Hikma will be responsible for the commercialisation of Ryaltris™ in the US
following approval. Hikma would also have the ability to produce the product utilizing
its nasal manufacturing capabilities in Columbus, Ohio. Hikma will provide Glenmark
with an upfront payment, regulatory approval and commercial milestone payments as
well as royalties.

> “We are happy to partner with Hikma in the US as Ryaltris™ is a perfect strategic
> fit in their near-term plan to build a branded nasal spray portfolio. This partnership
> gives us an opportunity to tap into the largest pharmaceutical market in the world.
> This step is aligned with our vision to make Ryaltris™ the first global brand 
> of Glenmark by launching it in several markets across the globe,” **said Glenn
> Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.**

Glenmark has studied Ryaltris™ in seven clinical trials involving more than 4,000
adult and adolescent patients (12 years of age and older). The FDA issued a Complete
Response Letter (CRL) to Glenmark regarding the NDA for Ryaltris™ in June 2019, 
citing deficiencies pertaining to the proposed manufacturing facility. The CRL did
not specify any deficiencies with the clinical data supporting the NDA for Ryaltris
™.

**About Seasonal Allergic Rhinitis**

According to the most recent CDC data, almost 20 million adults in the United Sates
are affected by seasonal allergic rhinitis every year. It is the primary diagnosis
in over 11 million doctor’s visits annually and is estimated to affect more than
seven percent of adults aged 18 years and over in the United States.

> “We are pleased to form this partnership with Glenmark, which builds on our market-
> leading position in nasal allergy sprays and advances our objective of growing
> our specialty business in the US,” **said Brian Hoffmann, President of Hikma Generics.**“
> Hikma Pharmaceuticals is the largest supplier of generic nasal sprays in the US.
> Adding Ryaltris™ is a significant step forward in expanding our US nasal spray
> leadership into branded medicines. Importantly, it will allow us to leverage our
> strong, existing specialty salesforce already calling on doctors with our specialty
> portfolio, and to potentially leverage our nasal spray manufacturing capabilities
> in Columbus, Ohio. We look forward to bringing this important new treatment option
> to millions of US patients.”

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