Glenmark Pharmaceuticals Announces Exclusive Licensing Agreement With Seqirus for its Investigational Seasonal Allergic Rhinitis Nasal Spray - Ryaltris - for Australia and New Zealand Markets

Friday, July 6, 2018 Drug News
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MUMBAI, July 6, 2018 /PRNewswire/ --

- Ryaltris[i] (olopatadine hydrochloride

665 mcg and mometasone furoate 25 mcg), is a an investigational novel fixed-dose combination nasal spray of an antihistamine and a steroid indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR)

- Glenmark to receive upfront payment, regulatory and commercial milestone payments from Seqirus for Ryaltris

- Glenmark plans to commercialize the Ryaltris in several markets globally, either on its own or through partnerships 

Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced that its subsidiary Glenmark Specialty S.A. has entered into an exclusive licensing agreement with Seqirus Pty. Ltd. (Seqirus), part of Australia-based specialty biotechnology company CSL Ltd., to commercialize Ryaltris in Australia and New Zealand.

     (Logo: http://mma.prnewswire.com/media/451507/PRNE_Glenmark_Logo.jpg )

Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)) is a novel, investigational, fixed-dose combination nasal spray of an antihistamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age.  

Under the terms of the agreement, Glenmark will be responsible for product supply and Seqirus will be responsible for regulatory filing and commercialization of the product in Australia and New Zealand. Glenmark will receive an upfront payment as well as regulatory and commercial milestone payments from Seqirus.

Australia has one of the world's highest rates of allergic rhinitis with nearly 20% of the country's population suffering annually from this disease. Allergic rhinitis can lead to a reduction in quality of life and functional impairment.[ii]

"We are delighted to collaborate with Seqirus to commercialize Ryaltris in Australia and New Zealand. Seqirus' strong presence in allergy in these markets makes them an ideal partner for Glenmark," said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals. "The partnership is also in line with our strategy of launching Ryaltris across markets either directly or through partnerships making it our first global brand," he added.

"We are very excited to be working with Glenmark on the distribution, marketing and sales of their novel allergic rhinitis product upon approval. Ryaltris is an important addition to Seqirus' growing product range and strengthens our broad portfolio of in-licensed medicines in Australia and New Zealand," said Dr. Lorna Meldrum, Seqirus' VP Commercial Operations.

In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the U.S. Food and Drug Administration (U.S. FDA), which was a milestone in the company's journey.

The company plans to commercialize Ryaltris in several key markets globally. Glenmark will explore commercial partnerships for Ryaltris in markets where it doesn't have direct presence.

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 a significant presence in generic drugs market and has improved lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit http://www.glenmarkpharma.com

About Seqirus

In Australia and New Zealand, Seqirus is a fully integrated pharmaceutical company operating with expertise in specialty and primary care pharmaceuticals and vaccines. The Seqirus sales and marketing teams are multi-award winning and recognised as leaders within the pharmaceutical industry. Globally, Seqirus is one of the world's largest influenza vaccine manufacturers. With extensive research and production expertise and manufacturing plants in the US, UK and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention of control of influenza globally.

[i] Application for registration of brand name Ryaltris has been accepted, advertised and is under process by IP Australia, The Registrar of Trademark.

[ii] Reference: William B Smith and Frank E Kette Med J Aust 2017; 206 (2): 60-61.

Media Contact : Ramkumar Uppara & Isha Trivedi isha.trivedi@glenmarkpharma.com +91-22-4018-98 Sr. Manager Corporate Communication Glenmark Pharmaceuticals

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