Glenmark Pharmaceuticals announced its subsidiary Glenmark Specialty has entered into an exclusive licensing agreement with Seqirus to commercialize Ryaltris in Australia and New Zealand.
Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)) is a novel, investigational, fixed-dose combination nasal spray of an antihistamine 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 product supply and Seqirus will be responsible for regulatory filing and commercialization of the product in Australia and New Zealand. Glenmark will receive an upfront payment as well as regulatory and commercial milestone payments from Seqirus.
Australia has one of the world's highest rates of allergic rhinitis with nearly 20% of the country's population suffering annually from this disease. Allergic rhinitis can lead to a reduction in quality of life and functional impairment.
"We are delighted to collaborate with Seqirus to commercialize Ryaltris in Australia and New Zealand. Seqirus' strong presence in allergy in these markets makes them an ideal partner for Glenmark," said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals. "The partnership is also in line with our strategy of launching Ryaltris across markets either directly or through partnerships making it our first global brand.”
"We are very excited to be working with Glenmark on the distribution, marketing and sales of their novel allergic rhinitis product upon approval. Ryaltris is an important addition to Seqirus' growing product range and strengthens our broad portfolio of in-licensed medicines in Australia and New Zealand," said Dr. Lorna Meldrum, Seqirus' VP Commercial Operations.
In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the U.S. Food and Drug Administration (FDA).
The company plans to commercialize Ryaltris in several key markets globally. Glenmark will explore commercial partnerships for Ryaltris in markets where it doesn't have direct presence.