Glenmark Pharmaceuticals and Hikma Enter Into an Exclusive Licensing Agreement for Commercializing Ryaltris™ Seasonal Allergic Rhinitis Nasal Spray in the US

• Under the terms of the agreement, Glenmark will be responsible for the continued development and regulatory approval of Ryaltris™ by the US FDA, while Hikma will be responsible for the commercialization of Ryaltris™ in the US
• Glenmark will receive an upfront payment, regulatory approval and commercial milestone payments as well as royalties from Hikma for Ryaltris™

MUMBAI, Feb. 27, 2020 /PRNewswire/ -- 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 Hikma Pharmaceuticals PLC (Hikma) for commercializing its novel nasal spray Ryaltris™ in the US.

The agreement with Hikma is Glenmark's fourth regional licensing deal for Ryaltris™. Glenmark has already signed licensing deals for commercializing Ryaltris™ in China, Australia, New Zealand and South Korea.

Ryaltris™ [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel 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 for the continued development and regulatory approval of Ryaltris™ by the US Food and Drug Administration (FDA). Hikma will be responsible for the commercialization of Ryaltris™ in the US, following approval. Hikma would also have the ability to produce the product utilizing its nasal manufacturing capabilities in Columbus, Ohio. Glenmark will receive an upfront payment, regulatory approval and commercial milestone payments as well as royalties from Hikma for Ryaltris™.

"We are happy to partner with Hikma in the US as Ryaltris™ is a perfect strategic fit in their near-term plan to build a branded nasal spray portfolio. This partnership gives us an opportunity to tap into the largest pharmaceutical market in the world. This step is aligned with our vision to make Ryaltris™ the first global brand of Glenmark by launching it in several markets across the globe," said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.

"We are pleased to form this partnership with Glenmark, which builds on our market-leading position in nasal allergy sprays and advances our objective of growing our specialty business in the US," said Brian Hoffmann, President of Hikma Generics. "Hikma is the largest supplier of generic nasal sprays in the US. Adding Ryaltris™ is a significant step forward in expanding our US nasal spray leadership into branded medicines. Importantly, it will allow us to leverage our strong, existing specialty salesforce already calling on doctors with our specialty portfolio, and to potentially leverage our nasal spray manufacturing capabilities in Columbus, Ohio. We look forward to bringing this important new treatment option to millions of US patients."

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). For more information, visit www.glenmarkpharma.com

About Hikma

Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

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