Glenmark Pharmaceuticals Announces Results from a Phase 3 Study of Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, in Patients Aged 6 to Under 12 Years

Press Release – For Immediate Release   Glenmark Pharmaceuticals Announces Results from a Phase 3 Study of Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, in Patients Aged 6 to Under 12 Years   The study of Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg] nasal spray) in  pediatric patients aged 6 to under 12 years of age met its primary endpoint, and results were consistent with  extensive clinical trial experience with Ryaltris in patients 12 years of age and older    Ryaltris, also known as GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset, and currently  under FDA review for the treatment of seasonal allergic rhinitis in patients 12 years of age and older  Mumbai, India; May 9, 2019 : Glenmark Pharmaceuticals, a global innovative pharmaceutical company, today announced positive results from a Phase 3 study of Ryaltris, an investigational fixed-dose combination nas al spray for the treatment of seasonal a llergic rhinitis (SAR). The study in patients aged 6 to under 12 years met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evenin g Reflective Total Nasal Symptom Score (rTNSS) compared to placebo.1 Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. “It has become increasingly important to conduct studies specifically designed for pediatric patients, so that we may gain insights into potential differences in safety, efficacy and dosing compared to studies in adult and adolescent populations,” said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals. “We are pleased to report that the safety and effectiveness observed in this pediatric population is consistent with our overall Phase 3 development program in SAR patients 12 years of age and older. These robust data contribute to the extensive clinical background supporting the effectiveness and tolerability of Ryaltris.”   The primary objective of the Phas e 3 study was to compare the effectiveness of Ry altris (administered as one spray in each nost ril, twice daily) versus a placebo nasal spray over 14 days in pediatric subjects (aged ≥6 to <12 year) with SAR. The study randomized 446 patients and 431 patients completed the study (96.6%). In the study, patients treated with Ryaltris compared to placebo showed a statistically significant improvement for the primary endpoint of average morning a nd evening rTNSS (p=0.001). Rates of treatme nt- emergent adverse events (TEAEs) were similar between Ryaltris ve rsus placebo (10.4% vs. 12.0%, respectively). The most common TEAEs included distortion of taste sensatio n (Ryaltris 1.3%, placebo 0.0%), headache (Ryaltris 1.3%, placebo 0.5%) and nose ble ed (Ryaltris 0.9%, placebo 2.3%).1 Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,0 00 adult and adolescent patients (12 years of age and older). Results from those clinical trials of Ryaltris have been previously presented at key medical meetings and full results from the study of Ryaltris in pediatric patients aged 6 to under 12 years of age will be published and presented at future meetings. If approved by the FDA, Ryaltris will be commercialized by Glenm ark Therapeutics Inc. USA, a wholly-owned subsidiary of Glenmar k Holding, SA, that is dedicated to launching a portfolio of branded products in the t herapeutic areas of respiratory and dermato logy in the US. About Seasonal Allergic Rhinitis According to the most recent CDC data, almost 20 million adults in the United Sates are affected by seasonal allergic rhinitis every year.2 It is the primary diagnosis in over 11 million doctor’s visits annually and is estimated to affect more than seven percent of adults aged 18 years and over in the United States.2,3 About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (n ew chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has a significant presence in the branded generics markets across emergi ng economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R& D centers. The Generics busines s of Glenmark services the requirements of the US and Western Europ ean markets. The API business sells its produc ts in over 80 countries, including the US , various countries in the EU, South America and India. 2 About Glenmark Therapeutics Glenmark Therapeutics Inc., USA is a, wholly-owned subsidiary of Glenmark Holding, SA. The com pany is dedicated to building a franchise of branded products for Glenmark Pharmaceuticals. Gl enmark Therapeutics will initially focus its efforts on launching and commercializing assets in the therapeutic areas of respiratory and dermatology. Glen mark Therapeutics has a short- and long-ter m pipeline of investigational medicines intend ed to meet the needs of patients sufferi ng from a variety of dermatological and res piratory conditions and is consistently working to expand its product portfolio. For further information, please contact: Isha Trivedi Glenmark, Mumbai, India Tel: +91 22 4018 9801 Email: [email protected] References 1. Data on file. 2. Blackwell DL, Villarroel MA. Tables of summary health stat istics for US adults: 2017 National Health Interview Survey. Available online at: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2017_SHS_Table_A-2.pdf. Accessed April 29, 2019. 3. National Ambulatory Medical Care Su rvey: 2010 Summary Tables, Table 13.

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