AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced that the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) for the evaluation of adult growth hormone deficiency (AGHD) has been accepted by the European Medicines Agency (EMA) for regulatory review.
“Our goal is to relieve the burden of AGHD testing for physicians worldwide and most importantly for patients and the EMA’s acceptance of our MAA brings us closer to achieving that,” said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris. “Our vision is to see that Macrilen™ becomes the future for AGHD management and the drug that endocrinologists and their staffs come to depend on as the preferred test for patients seeking answers.”
AGHD affects approximately 75,000 adults across the US, 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.
Macrilen™, an orally available ghrelin agonist, stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of Macrilen™ for the assessment of growth hormone deficiency (GHD).
“We believe that macimorelin can be a game changer for the endocrinology community,” said Dr. Richard Sachse, M.D., Ph.D., the company’s Senior Vice President, Chief Medical Officer and Chief Scientific Officer. “It is the first innovation in adult GHD testing in over 50 years and we hope it will eliminate the agony of current standards of testing which require physician-supervised administration and up to double digital patient blood draws over several hours, thus providing a significant reduction of the testing burden.”
On March 7, 2017, the Pediatric Committee of the EMA agreed to the company’s Pediatric Investigation Plan (“PIP”) for Macrilen™, a prerequisite for filing an MAA for any new medicinal product in Europe. The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen™ in AGHD. The start of the EMA review procedure for the MAA has now been confirmed by EMA as November 23, 2017.
Shares of Aeterna Zentaris closed today at $2.06, down $0.04 or nearly -2%. AEZS has a 1-year high of $4.25 and a 1-year low of $0.78. The stock’s 50-day moving average is $2.01 and its 200-day moving average is $1.66.
On the ratings front, Maxim analyst Jason Kolbert assigned a Buy rating on AEZS, with a price target of $4.00, in a report issued on November 9. The current price target represents a potential upside of 94% from where the stock is currently trading. According to TipRanks.com, Kolbert has a yearly average loss of 7.0%, a 36% success rate, and is ranked #4642 out of 4730 analysts.
Æterna Zentaris operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. It focuses on the development of Perifosine, Cetrotide, Ozarelix, AEZS-108 and AEZS-130.