Aeterna Zentaris Forms Strategic Review Committee and Appoints Michael Ward as CEO
Business WireJuly 20, 2017
CHARLESTON, S.C.--(BUSINESS WIRE)--
Aeterna Zentaris Inc. (AEZS) (AEZS.TO) (the “Company”), announced today that it has formed a special committee of independent directors (the “Strategic Review Committee”) to consider and evaluate various strategic and financing alternatives available to the Company to maximize shareholder value, including continuing to execute on its existing business plan and/or considering and recommending changes to the Company’s management and governance. The Strategic Review Committee will be chaired by Carolyn Egbert, and includes Michael Cardiff. The Strategic Review Committee is in the course of engaging a financial advisor to assist with this process. On July 18, the Company 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 has reached an important point in its evolution and wishes to conduct a strategic review of its plans, resources and opportunities, in order to best position itself to maximize stakeholder value.
David A. Dodd has ceased to be the Company’s President and CEO with immediate effect. The board of directors of the Company (the “Board”) has appointed Michael Ward as the Company’s Chief Executive Officer.
Mr. Ward has over thirty years of executive and legal experience in the healthcare, pharmaceutical and technology industries. Most recently, Mr. Ward served as Chief Compliance & Legal Officer and Corporate Secretary for Sagent Pharmaceuticals (SGNT), a global specialty generic pharmaceutical company, and led its sale to Nichi-Iko Pharmaceutical Co., Ltd. for $736 million. Mr. Ward has served as Strategic Advisor to Benevolent Capital Partners for the last five years and is currently a Partner with Outside GC LLC. Prior to Sagent Pharmaceuticals, Mr. Ward was Vice President, Assistant General Counsel of Global Compliance, Ethics & Litigation and Chief Privacy Officer at CDK Global. Mr. Ward has served in several executive roles and was responsible for business development, compliance, legal and operational matters in the healthcare, pharmaceutical and technology industries during his career. Mr. Ward graduated from Albion College and Case Western Reserve University Law School.
There can be no assurance that evaluation of strategic alternatives will result in any transaction being pursued, entered into or consummated. The Company does not intend to make further comment in regard to this process except as required by applicable securities laws or the policies of NASDAQ and the Toronto Stock Exchange.
The Strategic Review Committee has engaged Bennett Jones LLP as its legal advisor and Bayfield Strategy, Inc. as its strategic and communications advisor.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this patented compound and has significant patent protection left. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. The Company proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.
AGHD affects approximately 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.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel pharmaceutical therapies. We are engaged in drug development activities and in the promotion of products for others. We recently completed Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in non-U.S. territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit