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Glenmark Pharma secures product approval for Ryaltris in Australia

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

According to the company this paves the way for the launch of RyaltriinAustraliathroughSeqirus.Australiawill be the first market globally where Ryaltriswill be launched.

Seqirus, part ofAustralia-based specialty biotechnology company CSL Ltd.,entered into an exclusive licensing agreement inJuly 2018with Glenmark's subsidiary Glenmark Specialty S.A. to commercialize RyaltrisinAustralia.

Ryaltrisis 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. Ryaltriswill be manufactured at Glenmark's Baddi manufacturing facility, Himachal Pradesh, India.

“We are delighted to receive an approval from TGA for Ryaltristhrough our partnerSeqirusto commercialize RyaltrisinAustralia. Seqirus' strong presence in allergy in this market makes them an ideal partner for Glenmark,” saidGlenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.

Glenmark plans to commercialize Ryaltrisin several key markets globally. Glenmark will explore commercial partnerships for Ryaltrisin markets where it doesn't have direct presence.

Glenmark plans to commercialize Ryaltrisin several markets globally, either on its own or through partnerships.