Glenmark Gets Approval From Australian Regulator To Commercialise Ryaltris
Drugmaker Glenmark Pharmaceuticals Ltd. on Friday said that it has received approval from Australian regulator Therapeutic Goods Administration to commercialise Ryaltris in Australia through its partner Seqirus.
Ryaltris is a new fixed dose combination nasal spray of an antihistamine and a steroid indicated for treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients over 12 years of age in Australia.
"Glenmark... announced that Seqirus has received marketing approval for Ryaltris from the Therapeutic Goods Administration, Australia," the company said in a filing to Bombay Stock Exchange.
This paves the way for the launch of Ryaltris in Australia through their partner, Seqirus, Glenmark said.
Australia will be the first market globally where Ryaltris will be launched, the company said. Seqirus, part of Australia-based specialty biotechnology company CSL Ltd., entered into an exclusive licensing agreement in July last year with Glenmark's subsidiary Glenmark Specialty SA to commercialise Ryaltris in Australia.
Under the terms of the agreement, Glenmark will be responsible for product supply and Seqirus will be responsible for regulatory filing and commercialisation 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 in Himachal Pradesh.
Australia 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. In Australia and New Zealand, Seqirus is a pharmaceutical company operating with expertise in specialty and primary care pharmaceuticals and vaccines.
The shares of Glenmark Pharmaceuticals were trading at Rs 353.10 a piece on BSE in morning trade.