TORONTO, ON, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that Novo Nordisk Healthcare AG (“Novo Nordisk”), has exercised its right to terminate the amended development and commercialization license agreement (the “Commerical License”) previously entered into between Aeterna’s wholly-owned subsidiary and Novo for Macrilen™ (macimorelin), the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Following Novo’s 270-day notice period, Aeterna will regain full U.S. and Canadian rights to the product. Under the terms of the Commercial License, Novo Nordisk will return the regulatory approvals, the intellectual property and provide certain other assistance in order to aid in an orderly transition of Macrilen™ (macimorelin) rights to the Company. Until the end of that 270-day period, Commercial License requires Novo Nordisk to continue selling and promoting Macrilen™ (macimorelin) in the U.S., and Novo Nordisk’s financial support of the pivotal safety and efficacy DETECT-trial remains unchanged until the end of that notice period.
CHARLESTON, S.C., July 30, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ( the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that the abstract on study results of its first pediatric study on macimorelin has been selected for presentation at the 22nd European Congress of Endocrinology (e-ECE 2020) being held September 5-9, 2020.
At its November 2018 meeting, the European Medicines Agency's (EMA) human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union.
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Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Macrilen™ (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). The Company estimates that approximately 60,000 tests for suspected AGHD are being conducted each year across the United States, Canada and Europe
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the “Company”) today announced that, following its meeting with the U.S. Food and Drug Administration (the “FDA” or the “Agency”) on March 29, 2017, the Company intends to file a new drug application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”).
CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZS) (the “Company”) announced today that the Pediatric Committee (“PDCO”) of the European Medicines Agency (“EMA”) agreed to the Company’s Pediatric Investigation Plan (“PIP”) for Macrilen™ and agreed that the Company may defer conducting the PIP until after it files a Marketing Authorization Application (“MAA”) seeking marketing authorization for the use of Macrilen™ for the evaluation of adult growth hormone deficiency.