27 April 2017, Melbourne - IDT Australia Limited (ASX: IDT) today announced that the U.S. Food and Drug Administration (FDA) has affirmed the successful tech transfer of Pindolol Tablets, 5mg and 10mg, which is used in the treatment of hypertension via a CBE30 filing, thus clearing the way for a U.S. launch of the product. The annual U.S. market for Pindolol Tablets is approximately US $10 million, per IMS Health.
Pindolol launch stock is awaiting shipment to ANI Pharmaceuticals, Inc. (“ANI”), with a U.S. market launch anticipated in the coming weeks.
Arthur S. Przybyl, ANI’s President and CEO stated, “We are excited to progress the launch of the first product from our partnership with IDT Australia Ltd. which we entered in August 2015 and includes the exclusive rights to commercialise up to 18 previously marketed US generic drug products. We look forward to additional future launches through this partnership as we advance our collaboration.”
“This is a significant milestone for IDT and the ANI IDT partnership.” said Dr Paul MacLeman, IDT’s Managing Director. “Pindolol will be the first of IDT’s acquired generic drug products to be re-launched into the U.S.”
About Pindolol Tablets
Pindolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
For further information please contact:
IDT Australia Limited
Dr Paul MacLeman
Managing Director
(03) 9801 8888
Monsoon Communications
Rudi Michelson
(03) 9620 3333
About IDT
IDT Australia Ltd is developing a portfolio of 25 generic drugs to manufacture and sell via US distribution partners. With IDT’s 2016 temozolomide ANDA approval this signifies IDT’s move to rapidly become a specialty generics business with near term revenue upside.
IDT (ASX:IDT) is a public Australian pharmaceutical manufacturing company based in Boronia, Victoria, Australia. It has extensive experience in the development and production of high potency and high containment pharmaceutical products for local and international clients. IDT’s facilities are fully cGMP compliant and are regularly audited by the US FDA and Australian TGA. With an experienced team of specialists within world-class facilities, IDT provides a full-scale service for new drug development and scale-up, commercial active drug manufacture as well as a variety of oral and injectable finished drug dose forms.
Monsoon Communications
Level 1, 121 William Street
Melbourne VIC 3000
Ph: 03 9620 3333
www.monsoon.com.au
