Hikma, Glenmark ink licensing agreement for Ryaltris

Sandra Levy
Senior Editor
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Hikma and Glenmark Specialty have signed an exclusive agreement to commercialize Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray), an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis.

Glenmark will be responsible for the continued development and regulatory approval of Ryaltris by the Food and Drug Administration. Hikma will be responsible for the commercialization of Ryaltris in the United States 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 United States,” said Brian Hoffmann, president of Hikma generics.

Hoffmann added, “Hikma is the largest supplier of generic nasal sprays in the United States. Adding Ryaltris is a significant step forward in expanding our U.S. 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 U.S. patients.”

“We are happy to partner with Hikma in the United States 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, Glenmark’s chairman and managing director.