Shares of Aeterna Zentaris (NASDAQ: AEZS) are 6% higher in morning trade after the company said the European Medicines Agency’s (EMA) Pediatric Committee (PDCO) has agreed to the company’s Pediatric Investigation Plan (PIP) for Macrilen™. PDCO also agreed that Aeterna may defer conducting the PIP until after it files a Marketing Authorization Application (MAA) for the use of Macrilen™ for the evaluation of adult growth hormone deficiency. “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,” senior vice president, chief medical officer and chief scientific officer Dr. Richard Sachse, M.D., Ph.D. stated in the news release.
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About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company is engaged in drug development activities and in the promotion of products for others. Aeterna recently completed phase 3 studies of two internally developed compounds. The focus of the business development efforts is the acquisition of licenses to products that are relevant to the company’s therapeutic areas of focus. The company also intends to license out certain commercial rights of internally developed products to licensees in non-US territories where such out-licensing would enable it to ensure development, registration and launch of product candidates. Aeterna’s goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of its product portfolio, achieving successful commercial presence and growth, while consistently delivering value to shareholders, employees and the medical providers and patients who will benefit from such products. For more information, visit www.aezsinc.com.
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