Glenmark Pharmaceuticals Ltd., 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 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 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 commercialising 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.

Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray, the company’s respiratory pipeline asset is partnered with Hikma Pharmaceuticals PLC for the commercialisation in the US market. Ryaltris sales continues to progress well in Australia, after the successful launch earlier this year by Glenmark’s partner, Seqirus Pty. Ltd. Ryaltris was also recently launched in South Africa. Glenmark plans to initiate commercial launch in Ukraine and Uzbekistan in the next few months. Glenmark is supporting its partner Yuhan Corporation to launch Ryaltris by the end of the March 2021 in South Korea. Glenmark has received approval for Ryaltris in Australia, South Korea, Cambodia, Ukraine, Uzbekistan, Namibia and South Africa. The company had already filed an application for Ryaltris approval in the European Union, Canada, Russia, Brazil, Malaysia, Saudi Arabia and several other markets. Glenmark’s partner in China, Grand  Pharmaceutical (China) Co. Ltd., plans to submit an IND in this financial year.