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Hikma and Glenmark Pharmaceuticals Enter into Exclusive Licensing Agreement for Commercialising Ryaltris™ Seasonal Allergic Rhinitis Nasal Spray in the US

Friday, February 28, 2020

Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, and Glenmark Specialty S.A., a Swiss subsidiary of Glenmark Pharmaceuticals, a global innovative pharmaceutical company, today announce the signing of an exclusive US license agreement to commercialise Ryaltris™ (olopatadine hydrochloride and mometasone furoate nasal spray), an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR).

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 commercialisation 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. Hikma will provide Glenmark with an upfront payment, regulatory approval and commercial milestone payments as well as royalties.

"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."

"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.

Glenmark has studied Ryaltris™ in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). The FDA issued a Complete Response Letter (CRL) to Glenmark regarding the NDA for Ryaltris™ in June 2019, citing deficiencies pertaining to the proposed manufacturing facility. The CRL did not specify any deficiencies with the clinical data supporting the NDA for Ryaltris™.

About Seasonal Allergic Rhinitis

According to the most recent CDC data, almost 20 million adults in the United Sates are affected by seasonal allergic rhinitis every year. 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 years and over in the United States.

About Glenmark Pharmaceuticals

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
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P)

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 8,600 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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