Hikma Pharmaceuticals has signed an agreement with Glenmark Pharmaceuticals for exclusive US rights to Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, the companies said. According to the announcement, the deal includes an upfront payment, milestone payments, and royalties; the amounts were not disclosed.
Following approval of Ryaltris, Hikma would take responsibility for commercialization and could manufacture the nasal spray in a US facility. The announcement acknowledges that Glenmark received a complete response letter to its NDA for Ryaltris in June 2019, but notes that the FDA did not cite any issues with the clinical data.
Hikma Generics President Brian Hoffmann commented, “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.”
Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said, “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.”
In December 2019, Ryaltris was approved in Australia, where Seqirus has the commercialization rights. In South Korea, Yuhan Corporation will commercialize the nasal spray and Grandpharma has the commercialization rights for Ryaltris in China.
Read the Hikma and Glenmark press release.
