Insight on Hikma and Glenmark’s Exclusive Licensing Agreement for Commercialising Ryaltris Nasal Spray in the US

Hikma Pharmaceuticals PLC and Glenmark Specialty S.A., a Swiss subsidiary of Glenmark Pharmaceuticals, a global innovative pharmaceutical company signed  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. 

Why this deal?

• Hikma is the largest supplier of generic nasal sprays in the US.
• This deal will further strengthen the nasal spray portfolio of Hikma in US market.
• For Glenamark it’s a great boost, as Ryaltris will be perfect strategic fit in their nasal spray portfolio of Hikma.
• This partnership gives us an opportunity to tap into the largest pharmaceutical market in the world. This is the first global innovator brand of Glenmark by launching it in several markets across the globe.

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.

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