Chennai, (Asian independent) Pharma major Glenmark Pharmaceuticals Ltd on Monday said it is concluding the final, national phase of its marketing approval application process to enable launch of its innovative nasal spray Ryaltris across the European Union.
The company said Ryaltris (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg), will shortly be available in Austria, Belgium, the Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Italy, The Netherlands, Norway, Poland, Romania, Slovakia, Sweden, as well as 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 commercialisation of the nasal spray, following regulatory approval.
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.
According to Achin Gupta, Executive Vice President, Business Head EMEA-L (Europe, Middle East, Africa, Latam) upwards of 25 per cent of the population in Europe suffers from the debilitating symptoms of allergic rhinitis.
Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health for the commercialisation of Ryaltris in the US and Canada respectively.