Aeterna Zentaris Inc. (AEZS-NASDAQ) announced that it has been notified by the U.S. Food and Drug Administration (FDA), that the Company’s New Drug Application (NDA) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.
The Company remains confident that the FDA will approve its NDA and, accordingly, is moving forward with preparations to launch the product in the first quarter of 2018. In other news, the Company also announced that Mr. Kenneth Newport is no longer a member of the Board of Directors effective as of July 12, 2017.
Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. The product candidate has been granted orphan drug designation by the FDA for diagnosis of AGHD. Aeterna owns the worldwide rights to this patented compound and has significant patent protection remaining. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. Aeterna proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.
AGHD affects roughly 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.
Aeterna Zentaris Inc. (“Aeterna” or “the Company”) is a specialty biopharmaceutical company developing and commercializing therapies to enhance and improve patient lives. Focused on establishing revenues and profitability while optimizing resources to reduce its burn rate, the Company co-promotes two commercial products in multiple U.S. markets: (1) EMD Serono’s Saizen® [somatropin (rDNA origin) for injection] for pediatric and adult growth hormone deficiencies; and (2) Armune BioScience’s Apifiny®, a non-PSA blood test for evaluating prostate cancer risk. Aeterna further holds a pipeline of product candidates in development and is working to acquire or in-license other commercial products. One of the Company’s wholly owned product candidates, Zoptrex™ [zoptarelin doxorubicin (doxorubicin peptide conjugate targeting LHRH receptor–expressing tumors)], has completed the clinical program of a Phase 3 trial in advanced, recurrent, or metastatic endometrial cancer (EC)—a disease for which patients typically have a poor prognosis and there is no approved systemic therapy (except in Germany). Aeterna’s development program also includes Macrilen™ (macimorelin), which has also completed a confirmatory Phase 3 trial for the evaluation of Adult Growth Hormone Deficiency (AGHD) and has now been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017. Overall, Aeterna is focused on pursuing strategic initiatives consistent with becoming a commercially operating specialty biopharmaceutical company.