Glenmark and Bausch Health join together to commercialize RYALTRIS ™ nasal spray in Canada

• 10 year agreement with option to renew RYALTRIS ™ is currently under review by Health Canada with a proposed indication to treat seasonal allergic rhinitis in patients over 12 years of age
• Glenmark will receive an upfront payment, launch & sales‐based milestone payments in addition to royalties and supply price from sales of RYALTRIS™

MUMBAI, India, March 22, 2021 /PRNewswire/ -- Glenmark Pharmaceuticals, a research‐led, global integrated pharmaceutical company, today announced that its subsidiary Glenmark Specialty S.A. in Switzerland and an affiliate of Bausch Health Companies Inc. have entered into an exclusive licensing agreement for the commercialization of Glenmark's innovative nasal spray RYALTRIS ™ under review by Health Canada. Under the terms of the agreement, Glenmark will be responsible for regulatory approvals and supply of RYALTRIS ™ for the Canadian market. Bausch Health, Canada will be responsible for the commercialization of RYALTRIS ™ in the Canadian market, following regulatory approval. Glenmark will receive an upfront payment, launch & sales‐based milestone payments in addition to royalties and supply price from sales of RYALTRIS ™. RYALTRIS ™ (Olopatadine Hydrochloride 665 mcg and Mometasone Furoate 25 mcg), is currently under review by Health Canada with a proposed indication for the treatment of seasonal allergic rhinitis in adults and children over 12 years of age.

Commenting on the agreement, Mr. Sanjeev Krishan, President & Business Head ‐ North America, Glenmark Pharmaceuticals, said, "We are pleased to partner with Bausch Health Canada, and recognize their strong foothold in the prescription and OTC market in Canada. This agreement will help us reach a larger patient population and extend the multiple benefits of RYALTRIS ™ to a significant market. Glenmark continues to build a strong portfolio in respiratory medicine, and RYALTRIS ™ marks our first true global brand launch till date."

"We are pleased to add Ryaltris to our allergy product portfolio and eager to make it available to Canadian patients suffering from allergies," said Richard Lajoie, President of Bausch Health, Canada.

In Canada, allergic rhinitis is estimated to afflict 25% of the population, and can have a significant impact on sleep, work and school performancei. When approved in Canada, RYALTRIS ™ will offer a fixed‐dose combination of two different classes of medications in a convenient nasal spray presentation. A combination of intranasal antihistamines and intranasal corticosteroids may be beneficial and provide an additive effect on efficacy, resulting in superior relief of seasonal allergic rhinitis symptoms compared with monotherapyii.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd. (GPL) is a global research‐led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the
Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. For more information, visit www.glenmarkpharma.com

References: 

i Hossenbaccus, L., Linton, S., Garvey, S. et al. Towards definitive management of allergic rhinitis: best use of new and established therapies. Allergy Asthma Clin Immunol 16, 39 (2020).
https://doi.org/10.1186/s13223-020-00436-y

ii LaForce CF, Carr W, Tilles SA, Chipps BE, Storms W, Meltzer EO, et al. Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis.
Allergy Asthma Proc. 2010;31(2):132‐40.
Kaliner MA, Berger WE, Ratner PH, Siegel CJ. The efficacy of intranasal antihistamines in the treatment of allergic rhinitis. Ann Allergy Asthma Immunol.2011;106(2 Suppl):S6‐S11.
Price D, Shah S, Bhatia S, Bachert C, Berger W, Bousquet J, et al. A new therapy (MP29‐02) is effective for the long‐term treatment of chronic rhinitis. J Investig Allergol Clin Immunol. 2013;23(7):495‐503

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