Glenmark Pharmaceuticals and Hikma enter into partnership for commercialising RyaltrisT in the US

Glenmark Pharmaceuticals has announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Hikma Pharmaceuticals PLC (Hikma) for commercialising its novel nasal spray RyaltrisTM in the US.

The agreement with Hikma is Glenmark’s fourth regional licensing deal for RyaltrisTM. Glenmark has already signed licensing deals for commercialising RyaltrisTM in China, Australia, New Zealand and South Korea.

RyaltrisTM [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age.

Under the terms of the agreement, Glenmark will be responsible for the continued development and regulatory approval of RyaltrisTM by the US Food and Drug Administration (FDA). Hikma will be responsible for the commercialisation of RyaltrisTM in the US following approval. Hikma would also have the ability to produce the product utilising its nasal manufacturing capabilities in Columbus, Ohio.

Glenmark will receive an upfront payment, regulatory approval and commercial milestone payments as well as royalties from Hikma for RyaltrisTM.

“We are happy to partner with Hikma in the US as RyaltrisTM 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 RyaltrisTM the first global brand of Glenmark by launching it in several markets across the globe,” said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.

“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, Hikma Generics. “Hikma is the largest supplier of generic nasal sprays in the US. Adding RyaltrisTM 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.”