Glenmark Pharmaceuticals on Thursday said it has entered into an exclusive licensing agreement with Hikma Pharmaceuticals PLC for commercialising its novel nasal spray Ryaltris in the US.
The company, however, did not disclose the amount that it stands to receive from Hikma.
The licensing pact for Ryaltris has been signed between the company's Swiss subsidiary, Glenmark Specialty SA and Hikma Pharmaceuticals PLC (Hikma).
Ryaltris 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, Mumbai-based Glenmark will be responsible for the continued development and regulatory approval of Ryaltris by the US Food and Drug Administration (USFDA).
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, it added.
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Glenmark said will receive an upfront payment, regulatory approval and commercial milestone payments as well as royalties from Hikma for Ryaltris.
The agreement with Hikma is Glenmark's fourth regional licensing deal for Ryaltris. The company has already signed licensing deals for commercialising Ryaltris in China, Australia, New Zealand and South Korea.
"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," Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said.
"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," he added.
Hikma Generics President Brian Hoffmann said Hikma is the largest supplier of generic nasal sprays in the US and adding Ryaltris is a significant step forward in expanding the company's US nasal spray leadership into branded medicines.
"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," Hoffmann added.