Glenmark Pharmaceuticals said that it has received marketing approval for its fixed-dose combination nasal spray Ryaltris in 13 countries across the EU and UK.
Glenmark is set to launch Ryaltris directly in the markets of Czech Republic, Slovakia, Poland, and the UK. Ryaltris will be marketed in the rest of Europe by the Menarini Group as part of its exclusive licensing agreement with Glenmark.
Ryaltris (olopatadine 665 mcg and mometasone furoate 25 mcg), is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children 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.
Robert Crockart, chief commercial officer of Glenmark Pharmaceuticals, said, Allergic rhinitis is both widespread and underreported, making it challenging to diagnose and treat in time. It impacts a person's quality of life and can lead to functional impairments, while also increasing the risk of asthma.
This marketing approval will pave the way for effective and timely treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other regions where Ryaltris has been launched, and we hope to extend this relief to more people across the world.
Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health for the commercialisation of Ryaltris in the US and Canada, respectively. In April this year, Glenmark concluded the DCP regulatory procedure in Europe, enabling approval in 17 countries across EU and UK.
During FY21-22, Glenmark also received regulatory approval for Ryaltris in Philippines, Zambia, Ecuador and Peru. Ryaltris sales continue to progress well in Australia, South Africa, Ukraine and Uzbekistan.
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Glenmark also initiated the commercial launch in Russia in Q1, FY21-22. The company is awaiting regulatory approvals for its filings in various markets across Canada, Brazil, Malaysia, Saudi Arabia and several other emerging markets.
Currently, Ryaltris is under review with the US Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the US. Glenmark's response to the Agency's complete response letter (CRL) was submitted to the US FDA in July 2021.
Glenmark's partner in China, Grand Pharmaceutical (China) Co., finalized the Phase 3 protocol for China, and submitted the IND application in July 2021. In South Korea, Glenmark is working with its partner Yuhan Corporation, to potentially launch the product by H2, FY21-22.
Also, the company is working to submit the application for paediatric efficacy supplement in the country. In June 2021, Glenmark's partner in Australia, Seqirus received positive initial feedback from the TGA for the pediatric indication expansion.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries.
The pharmaceutical company posted a 20.7% rise in consolidated net profit to Rs 306.53 crore on 27.6% increase in net sales to Rs 2,946 crore in Q1 FY22 over Q1 FY21.
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