Glenmark's Ryaltris® nasal spray now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age

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• The launch will ensure much-needed access to a novel fixed-dose combination nasal spray for this chronic condition • This marks Glenmark's first innovative product approval in the European Union MUMBAI, India, April 26, 2021 /PRNewswire/ -- Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company, is concluding the final, national phase of its marketing approval application process to enable launch of its innovative nasal spray in 17 countries in the European Union. Ryaltris® (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg), will shortly be available in Austria, Belgium, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Italy, The Netherlands, Norway, Poland, Romania, Slovakia, Sweden, and the UK.

Glenmark will commercialise Ryaltris® on its own in select markets. In some countries such as France, Italy, Spain and the Balkan region, Menarini Group will lead the commercialisation effort, as part of an exclusive licensing agreement signed with Glenmark in 2020. Under the terms of the agreement, Glenmark is responsible for the continued development and regulatory approval of Ryaltris® in these markets, while Menarini will lead the scientific information and commercialization of Ryaltris®, following regulatory approval. Glenmark has received an upfront payment and will additionally receive launch & sales based milestone payments from Menarini for Ryaltris® sales.

Ryaltris®, 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 allergic rhinitis (AR) in patients over 12 years of age. It relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes.

Achin Gupta, Executive Vice President, Business Head EMEA-L (Europe, Middle East, Africa, Latam) Glenmark Pharmaceuticals, said, 'Despite many treatments being available for allergic rhinitis, Glenmark is excited to launch Ryaltris ® as the only first line combination inhaler treatment option for patients across Europe. Upwards of 25% of the population in Europe suffers from the debilitating symptoms of allergic rhinitis, so we hope that Ryaltris ® will bring some of these real benefits - a simple inhaler, offering fast and effective relief.' Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health for the commercialisation of Ryaltris® in the US and Canada respectively. Ryaltris® sales continue to progress well in Australia, after the successful launch in 2020 by Glenmark's partner, Seqirus Pty. Ltd. Ryaltris® was also recently launched in South Africa, Ukraine and Uzbekistan. So far, Glenmark has received approval for Ryaltris® in Australia, South Korea, Cambodia, Ukraine, Uzbekistan, Namibia, Russia, South Africa, and Ecuador. Ryaltris® is currently under regulatory review in Canada, 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.

About Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. For more information, visit PWR PWR