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Glenmark Pharmaceuticals Announces New Data Presentations on RyaltrisTM at the ACAAI Annual Scientific Meeting 2018

Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset
The company’s New Drug Application (NDA) for Ryaltris is under review with the U.S. Food and Drug Administration (FDA), and the Prescription Drug User Fee Act (PDUFA) target action date for completion of the FDA review is March 21, 2019
Mahwah, NJ; November 15, 2018 – Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company is presenting new data for for its leading respiratory pipeline candidate Ryaltris^TM (rye - al’ - tris) (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting 2018 (ACAAI 2018) in Seattle, Washington. Ryaltris is an investigational fixed-dose combination nasal spray intended for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. “Ryaltris” has been conditionally accepted by the FDA as the brand name.

“Nearly 50% of people with SAR rely on multiple therapies to treat their symptoms,¹ and this poly treatment approach may be ineffective or suboptimal for many of these patients,”² said Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals. “We look forward to sharing efficacy data, as well as long-term safety data on Ryaltris, at ACAAI 2018.”
The scheduled times (noted in Pacific time) of the presentations at the Washington State Convention Center are as follows:

• Olopatadine/Mometasone Combination Nasal Spray Effectively Improves Seasonal Allergic Rhinitis Nasal Symptoms and Quality of Life
  • Poster #454
  • Friday, November 16th 5:40 PM PT

• Seasonal Allergic Rhinitis Nasal Symptoms and Quality of Life Improvements with Olopatadine/Mometasone Combination Nasal Spray
  • Poster #455
  • Friday, November 16th 5:50 PM PT

• Long-Term Safety and Efficacy of Olopatadine/Mometasone Combination Nasal Spray in Patients with Perennial Allergic Rhinitis
  • Poster #456
  • Saturday, November 17th 12:00 PM PT

About Seasonal Allergic Rhinitis

According to the most recent CDC data, over 17 million adults in the United States are affected by seasonal allergic rhinitis every year.³ 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 and over in the United States.^3,4

About Glenmark’s Respiratory Pipeline

Glenmark’s respiratory pipeline is specifically aimed at addressing the global public health burden of allergic rhinitis, asthma and chronic obstructive pulmonary disease (COPD), and includes investigational treatments across the disease spectrum. This includes Ryaltris (GSP 301 Nasal Spray), an investigational combination antihistamine plus steroid nasal spray for the treatment of seasonal allergic rhinitis. It also includes GBR 310 (omalizumab), a proposed biosimilar candidate intended for the treatment of allergic asthma and chronic idiopathic urticaria; and GRC 39815, which is being investigated pre-clinically for the treatment of COPD and other respiratory diseases.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit http://www.localhost:10005/.

For further information, please contact:
An Phan Glenmark Corporate Communications, Paramus,
+1-201-331-4218

Isha Trivedi, Glenmark, Mumbai, India +91-22-4018-9801 corpcomm@glenmarkpharma.com

1. Marple BF, et al. Otolaryngol Head Neck Surg. 2007;136(6 Suppl):S107-124.3.
2. Meltzer EO. Immunol Allergy Clin North Am. 2016;36(2):235-248.4
3. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2014, Table 3, 4.
4. National Ambulatory Medical Care Survey: 2010 Summary Tables, Table 13.

Glenmark Pharmaceuticals Announces New Data Presentations on RyaltrisTM at the ACAAI Annual Scientific Meeting 2018

Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset
The company’s New Drug Application (NDA) for Ryaltris is under review with the U.S. Food and Drug Administration (FDA), and the Prescription Drug User Fee Act (PDUFA) target action date for completion of the FDA review is March 21, 2019
Mahwah, NJ; November 15, 2018 – Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company is presenting new data for for its leading respiratory pipeline candidate Ryaltris^TM (rye - al’ - tris) (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting 2018 (ACAAI 2018) in Seattle, Washington. Ryaltris is an investigational fixed-dose combination nasal spray intended for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. “Ryaltris” has been conditionally accepted by the FDA as the brand name.

“Nearly 50% of people with SAR rely on multiple therapies to treat their symptoms,¹ and this poly treatment approach may be ineffective or suboptimal for many of these patients,”² said Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals. “We look forward to sharing efficacy data, as well as long-term safety data on Ryaltris, at ACAAI 2018.”
The scheduled times (noted in Pacific time) of the presentations at the Washington State Convention Center are as follows:

• Olopatadine/Mometasone Combination Nasal Spray Effectively Improves Seasonal Allergic Rhinitis Nasal Symptoms and Quality of Life
  • Poster #454
  • Friday, November 16th 5:40 PM PT

• Seasonal Allergic Rhinitis Nasal Symptoms and Quality of Life Improvements with Olopatadine/Mometasone Combination Nasal Spray
  • Poster #455
  • Friday, November 16th 5:50 PM PT

• Long-Term Safety and Efficacy of Olopatadine/Mometasone Combination Nasal Spray in Patients with Perennial Allergic Rhinitis
  • Poster #456
  • Saturday, November 17th 12:00 PM PT

About Seasonal Allergic Rhinitis

According to the most recent CDC data, over 17 million adults in the United States are affected by seasonal allergic rhinitis every year.³ 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 and over in the United States.^3,4

About Glenmark’s Respiratory Pipeline

Glenmark’s respiratory pipeline is specifically aimed at addressing the global public health burden of allergic rhinitis, asthma and chronic obstructive pulmonary disease (COPD), and includes investigational treatments across the disease spectrum. This includes Ryaltris (GSP 301 Nasal Spray), an investigational combination antihistamine plus steroid nasal spray for the treatment of seasonal allergic rhinitis. It also includes GBR 310 (omalizumab), a proposed biosimilar candidate intended for the treatment of allergic asthma and chronic idiopathic urticaria; and GRC 39815, which is being investigated pre-clinically for the treatment of COPD and other respiratory diseases.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit http://www.localhost:10005/.

For further information, please contact:
An Phan Glenmark Corporate Communications, Paramus,
+1-201-331-4218

Isha Trivedi, Glenmark, Mumbai, India +91-22-4018-9801 corpcomm@glenmarkpharma.com

1. Marple BF, et al. Otolaryngol Head Neck Surg. 2007;136(6 Suppl):S107-124.3.
2. Meltzer EO. Immunol Allergy Clin North Am. 2016;36(2):235-248.4
3. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2014, Table 3, 4.
4. National Ambulatory Medical Care Survey: 2010 Summary Tables, Table 13.