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Glenmark Pharmaceuticals to Present New Analysis of Pooled Data on Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, at the AAAAI 2019 Annual Meeting

Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), also known as GSP 301 Nasal Spray, is the company's leading respiratory pipeline asset and currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of seasonal allergic rhinitis in patients 12 years and older


News provided by

Glenmark Pharmaceuticals

Feb 19, 2019, 10:00 ET

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PARAMUS, N.J., Feb. 19, 2019 /PRNewswire/ -- Glenmark Pharmaceuticals, a global innovative pharmaceutical company, today announced upcoming presentations of pooled data from clinical studies of Ryaltris™ (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray),also known as GSP 301 Nasal Spray, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older, at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019) in San Francisco, California. "Ryaltris" has been conditionally accepted by the FDA as the brand name.

“We continue to evaluate the clinical profile of Ryaltris based on findings from our completed efficacy and safety studies. We are pleased for the opportunity to present these data at AAAAI 2019, these pooled analyses on key outcomes from thousands of patients provide additional insights into the potential effectiveness of Ryaltris,” said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals.”

Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from clinical trials of Ryaltris have been previously presented at key medical meetings.

If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching and commercializing a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the United States.

Additional details regarding the dates and times of these presentations are below:

  • Rapid Nasal Symptom Onset of Action and Ocular Symptom Relief With Olopatadine/Mometasone Combination Nasal Spray in Patients with Seasonal Allergic Rhinitis: A Pooled Analysis
    • Saturday, February 23, 9:45 AM – 10:45 AM
    • Poster# 188; Moscone Center South, Exhibition Level, Hall B
  • Olopatadine/Mometasone Combination Nasal Spray for the Treatment of Seasonal Allergic Rhinitis: A Pooled Analysis of Efficacy and Safety
    • Saturday, February 23, 9:45 AM – 10:45 AM
    • Poster# 189; Moscone Center South, Exhibition Level, Hall B
  • Quality of Life Improvements Following Treatment with Olopatadine/Mometasone Combination Nasal Spray in Patients with Seasonal Allergic Rhinitis: A Pooled Analysis
    • Saturday, February 23, 9:45 AM – 10:45 AM
    • Poster# 186; Moscone Center South, Exhibition Level, Hall B

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.1 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.1,2

About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization with operations in more than 80 countries. 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 (new 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, immunology and pain.

About Glenmark Therapeutics
Glenmark Therapeutics Inc., USA is a, wholly-owned subsidiary of Glenmark Holding, SA. The company is dedicated to building a franchise of branded products for Glenmark Pharmaceuticals. Glenmark Therapeutics will initially focus its efforts on launching and commercializing assets in the therapeutic areas of respiratory and dermatology.  Glenmark Therapeutics has a short- and long-term pipeline of investigational medicines intended to meet the needs of patients suffering from a variety of dermatological and respiratory conditions and is consistently working to expand its product portfolio.

1 Blackwell DL, Villarroel MA. Tables of summary health statistics 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
2
 National Ambulatory Medical Care Survey: 2010 Summary Tables, Table 13.

SOURCE Glenmark Pharmaceuticals

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