Glenmark Pharmaceuticals And Hikma Sign Exclusive Licensing Agreement

HIGHLIGHTS

  • Glenmark Specialty S.A and Hikma Pharmaceuticals PLC have signed an agreement to commercialize Ryaltris™.
  • Ryaltris™ can treat the symptoms associated with seasonal allergic rhinitis.

Research-led global integrated pharmaceutical company Glenmark Pharmaceuticals Ltd. has announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Hikma Pharmaceuticals PLC. This agreement is about the commercialization of Glenmark’s novel nasal spray Ryaltris™ in the USA.

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

Ryaltris™ contains 665 mcg olopatadine hydrochloride and 25 mcg mometasone furoate. Developed by Glenmark, it is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid. It can be used for treating the symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age.

Under the terms of the agreement, Glenmark has a responsibility to continue to develop Ryaltris™ and obtain the regulatory approval by the US Food and Drug Administration (FDA). Hikma’s responsibility is to commercialize Ryaltris™ in the USA following approval. Hikma can also produce the product utilizing its nasal manufacturing capabilities in Columbus, Ohio. Glenmark is to receive an upfront payment, commercial milestone payments,  and regulatory approval, along with royalties from Hikma for Ryaltris™.

A New Alliance Announced in Pharmaceuticals Industry

Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals, says:

“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.”

Brian Hoffmann, President of Hikma Generics, says:

“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. 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.”

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