LONDON: Hikma Pharmaceuticals and Glenmark Specialty, a Swiss subsidiary of Glenmark Pharmaceuticals, 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 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 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.”

“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.