Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Menarini Group (Menarini) for commercializing its innovative nasal spray Ryaltris across 33 countries in Europe, including the Balkan region.

Ryaltris [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 the 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 Ryaltris in these markets. Menarini will be responsible for the scientific information and the commercialization of Ryaltris in those markets, following regulatory approval. Glenmark will receive an upfront payment as well as launch & sales-based milestone payments from Menarini for Ryaltris sales.

“We are excited to partner with Menarini for Ryaltris across Europe as they have a proven track record in partnering and commercializing respiratory products in the region. This partnership is another step in establishing Glenmark’s respiratory focus in Europe. While Glenmark will launch Ryaltris through its own front ends in some markets, this arrangement will allow the product to compete across Europe. This is also aligned with our vision to make Ryaltris the first global brand of Glenmark by launching it in several markets across the world,” said Achin Gupta, Executive Vice President, Business Head EMEA-L (Europe, Middle East, Africa, Latam) Glenmark Pharmaceuticals.

“We are delighted to have undertaken this exclusive licensing agreement with Glenmark Pharmaceuticals. Ryaltris is a perfect addition to our European respiratory and allergy portfolio and we can count on our established experience in the relevant therapeutic area to bring this novel option to patients. We look forward to receiving Ryaltris registration and being able to launch operations as soon as practicable,” commented Pio Mei, General Manager Menarini Group