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/ -- Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) ("Bausch Health") and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), are pleased to announce that RYALTRIS (olopatadine hydrochloride and mometasone furoate nasal spray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.1
"This Health Canada approval will allow Bausch Health to soon make RYALTRI S available to Canadians, providing an innovative therapy option for seasonal allergic rhinitis," Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health said. "This is part of our ongoing commitment to being a trusted partner in the healthcare of Canadians."
RYALTRIS is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray. The onset of action for nasal symptom relief occurs within 15 minutes after administration of RYALTRIS.1
"We are very pleased that Bausch Health, Canada will soon be able to bring the benefits of the novel drug RYALTRIS to the patients in Canada seeking a new treatment for seasonal allergic rhinitis. RYALTRIS is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world, and now coming to Canada, adding to our global respiratory leadership," said Brendan O'Grady, Chief Executive Officer - Global Formulations Business, Glenmark Pharmaceuticals Ltd.
About RYALTRIS
The efficacy and safety of RYALTRIS were established in a clinical studies program conducted by Glenmark in over 3,000 patients with SAR. Twice-daily RYALTRIS provided statistically significant improvement in both nasal and ocular symptoms vs. placebo, as well as the statistically significant onset of action in nasal symptom relief vs. placebo at 15 minutes, across three randomized, double-blind phase 3 studies (P<0.05). RYALTRIS demonstrated a safety profile typical of that observed with intranasal drugs of the same class.1
Important Safety Information for RYALTRIS
RYALTRIS is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin. In 14-day clinical studies of patients with SAR taking RYALTRIS twice a day, the most common adverse events observed were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%). RYALTRIS should not be used by anyone who has had an allergic reaction to olopatadine or mometasone or to any ingredient in the formulation or have untreated fungal, bacterial, or tuberculosis infections of the respiratory tract. Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening of pre-existing infections (e.g. tuberculosis) with fungi, bacteria or viruses can occur; including fatal chickenpox, measles and herpes infections in susceptible patients. RYALTRIS should be used under close medical supervision in anyone who has had nose bleeds or nasal perforation. Recurrence, worsening or persistence of these nasal problems can occur. RYALTRIS' effect on pregnancy and through transmission in breast milk is not known. Consult a doctor if the person is pregnant, plans to become pregnant or breastfeeding, to ensure it is safe for them to use.1
REFERENCES 1 Bausch Health, Canada, RYALTRIS Product Monograph
About Bausch Health Companies Inc.
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our approximately 88.7% ownership of Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world's top 50 companies in the off-patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit www.glenmarkpharma.com.
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