Product Approval in Australia for Glenmark Pharmaceutical's Ryaltris

Glenmark Pharmaceuticals, a research-led global integrated pharmaceutical company, gets marketing approval from Therapeutic Goods Administration (TGA), Australia for its product-Ryatris, which is a new fixed-dose combination nasal spray of an antihistamine and a steroid indicated for the treatment of symptoms associated with allergic rhinitis (AR) and rhino conjunctivitis in patients aged 12 and over. This paves the way for the launch of Ryaltris in Australia through Seqirus, which is a part of Australia-based specialty biotechnology company CSL Ltd.

Glenmark plans to commercialize Ryaltris in several key markets globally and will explore commercial partnerships for Ryaltris in markets where it doesn't have direct presence. The first market where Ryaltris will be launched is Australia, which has one of the world's highest rates of allergic rhinitis with nearly 20 percent of the country's population suffering annually from this disease. The allergic rhinitis can lead to a reduction in quality of life and functional impairment.

Seqirus and Glenmark’s subsidiary Glenmark Specialty S.A entered into an exclusive licensing agreement in

We are delighted to receive an approval from TGA for Ryaltris through our partner Seqirus to commercialize Ryaltris in Australia

July 2018 to commercialize Ryaltris in Australia. Under the terms of the agreement, Glenmark is responsible for product supply and Seqirus is 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.

“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,” says 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,” says Dr. Lorna Meldrum, Seqirus' VP Asia Pacific Commercial Operations.