Glenmark Pharmaceuticals Enters Into an Exclusive License Agreement With Grandpharma (China) Co. Ltd. for Commercializing Investigational Seasonal Allergic Rhinitis Nasal Spray Ryaltris in China
MUMBAI, February 6, 2019 /PRNewswire/ --
- Under the terms of the agreement, Glenmark will be responsible to manufacture and supply Ryaltris, while Grandpharma will be responsible for regulatory filing and commercialization of Ryaltris in China
- Glenmark will receive an upfront payment, regulatory filing, regulatory approval and commercial milestone payments as well as royalties from Grandpharma for Ryaltris
Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Grandpharma (China) Co. Ltd. (Grandpharma) for commercializing its novel nasal spray Ryaltris in China.
The agreement with Grandpharma is Glenmark's third regional licensing deal for Ryaltris. Glenmark has already signed licensing deals for commercializing Ryaltris in Australia, New Zealand and South Korea.
Ryaltris [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel, investigational, fixed-dose combination nasal spray of an anti-histamine 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 to manufacture and supply Ryaltris, while Grandpharma will be responsible for regulatory filing and commercialization of Ryaltris in China. Glenmark will receive an upfront payment, regulatory filing, regulatory approval and commercial milestone payments as well as royalties from Grandpharma for Ryaltris.
"We are happy to partner with Grandpharma in China as its product portfolio complements well with Ryaltris and this partnership gives us an opportunity to tap into one of the largest pharmaceutical markets in the world. This step is aligned with our vision to make Ryaltris the first global brand of Glenmark through launches in multiple markets across the globe," said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.
In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the US Food and Drug Administration (US FDA), which is currently under review with the regulator.
Glenmark plans to commercialize Ryaltris in various markets globally. The company will continue to explore commercial partnerships for Ryaltris in markets where it doesn't have direct presence.
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 (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, dermatology and respiratory.
The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.
About Grandpharma (China) Co. Ltd.
Grandpharma (China) Co. Ltd. (Grandpharma) is a pharmaceutical company engaged in developing, manufacturing and selling of pharmaceutical products (formulations & APIs) and medical devices in the People's Republic of China. Grandpharma was founded in 1939 and became a principal subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited in 2008, a public company listed in Hong Kong Exchanges and Clearing Limited.