Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, today announced that Seqirus Pty. Ltd. (Seqirus) has received marketing approval for Ryaltris® from the Therapeutic Goods Administration (TGA), Australia.

This paves the way for the launch of  Ryaltris® in Australia through Seqirus. Australia will be the first market globally where Ryaltris® will be launched.

Seqirus, part of Australia-based specialty biotechnology company CSL Ltd.,  entered into an exclusive licensing agreement in July 2018 with Glenmark's subsidiary Glenmark Specialty S.A. to commercialize Ryaltris® in Australia.

Ryaltris® is a new fixed-dose combination nasal spray of an antihistamine and a steroid, indicated for treatment of symptoms associated with allergic rhinitis (AR) and rhinoconjunctivitis 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. Glenmark is entitled to receive commercial milestone payments from Seqirus. Ryaltris® will be manufactured at Glenmark's Baddi manufacturing facility, Himachal Pradesh, India.

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.[ii]

"We are delighted to receive an approval from TGA for Ryaltris® through our partner Seqirus to commercialize Ryaltris® in Australia. Seqirus' strong presence in allergy in this market makes them an ideal partner for Glenmark," said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.

"We are very excited to be working with Glenmark on the distribution, marketing and sales of their novel fixed dose combination product for allergic rhinitis. Ryaltris® is an important addition to Seqirus' growing product range and strengthens our broad portfolio of in-licensed pharmaceuticals and vaccines in Australia," said Dr. Lorna Meldrum, Seqirus' VP Asia Pacific Commercial Operations.

Glenmark 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.