Mumbai, Jan 10 (GCBusiness) Pharma Major Glenmark Pharmaceuticals Ltd on Thursday announced that its Suisse subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Yuhan Corporation for commercialising its novel nasal spray Ryaltris in South Korea.
The agreement with Yuhan is Glenmark’s second regional licensing deal for Ryaltris. In July 2018, Glenmark entered into an exclusive licensing agreement with Seqirus Pty Ltd to commercialise Ryaltris in Australia and New Zealand, company said in a filing with BSE.
Ryaltris [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel, investigational, 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 manufacturing and supply of the product, while Yuhan will be responsible for regulatory filing and commercialization of Ryaltris in South Korea.
Glenmark will receive an upfront payment, regulatory and commercial milestone payments as well as royalties from Yuhan.
“This partnership with Yuhan is in line with our vision to make Ryaltris the first global brand of Glenmark by launching it in several key markets. We are happy to collaborate with Yuhan as it is a strong and reputed player in South Korea and is aligned with Glenmark’s objective to provide quality novel products to fulfill unmet needs of patients,” said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.
In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the US Food and Drug Administration (USFDA), which is currently under review with the regulator.
Glenmark plans to commercialise Ryaltris in various markets globally. The company will continue to explore commercial partnerships for Ryaltris in markets where it doesn’t have direct presence.