Stock Update (NASDAQ:AEZS): AEterna Zentaris Inc. (USA) Announces EMA Pediatric Committee Agreement on the Pediatric Investigation Plan for Macrilen


AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced 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.

As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An accepted PIP is a prerequisite for filing an MAA for any new medicinal product in Europe. However, the Company will be able to file an MAA substantially earlier than if it was required to complete the PIP before filing, because the PDCO permitted the Company to defer conducting the studies defined in the PIP.

The Company’s PIP provides for a dose-escalation safety and PK/PD study followed by a diagnostic efficacy and safety study. The goal of the first study is to establish a dose that can safely be administered to pediatric patients and that causes a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having growth hormone deficiency (“GHD”). The recommended dose derived from this study will be evaluated in the second study for diagnostic efficacy and safety. Both studies will be conducted in patients at least three years old who are undergoing the study sites’ regular diagnostic evaluation for the presence of GHD.

Dr. Richard Sachse, M.D., Ph.D., Senior Vice President, Chief Medical Officer and Chief Scientific Officer of the Company, said: “PDCO’s agreement that we may defer conducting our PIP, allowing us to go forward with an MAA in adults prior to initiating of the pediatric development program, is an important step forward in our efforts to bring Macrilen™ to market. Likewise, acceptance of our PIP is an important regulatory milestone for the product. At this time, we are looking forward to our upcoming FDA meeting, which has been scheduled for late March 2017, as a pre-requisite for a potential NDA submission based on our most recently announced completion of the pivotal Phase 3 study. Similarly, we are preparing for meetings with European agencies to discuss whether the conducted development program suffices for an MAA.”

Shares of Aeterna Zentaris are up nearly 10% to $3.35 in pre-market trading Tuesday. AEZS has a 1-year high of $5.59 and a 1-year low of $2.35. The stock’s 50-day moving average is $2.96 and its 200-day moving average is $3.44.

On the ratings front, AEZS has been the subject of a number of recent research reports. In a report issued on February 14, Maxim analyst Jason Kolbert reiterated a Buy rating on AEZS, with a price target of $10, which implies an upside of 228% from current levels. Separately, on January 6, Canaccord’s Neil Maruoka reiterated a Buy rating on the stock and has a price target of $5.50.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Neil Maruoka have a yearly average loss of -13.4% and -3.6% respectively. Kolbert has a success rate of 32% and is ranked #4440 out of 4511 analysts, while Maruoka has a success rate of 38% and is ranked #4120.

Æterna Zentaris, Inc. 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. AEterna Zentaris was founded on September 12, 1990 and is headquartered in Montreal, Canada.

 

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