(GlobeNewswire) - Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced the appointment of Paul Streck, M.D., as chief medical officer (CMO), effective January 21, 2019. He will report to Bob Azelby, Alders president and chief executive officer.
Dr. Streck brings more than 25 years of experience in drug development, regulatory and medical affairs leadership across both large and small publicly traded biopharmaceutical companies. He joins Alder from Insmed Incorporated, where he served as chief medical officer and played an instrumental role as a member of the executive leadership team, successfully leading the Arikayce regulatory filing, approval and launch. Prior to Insmed, Dr. Streck was GlaxoSmithKline (GSK) plcs group vice president and global medical lead of the Immuno-inflammation division responsible for the immunology portfolio strategy, including Benlysta and sirukumab. Before GSK, Dr. Streck spent eight years at Shire plc, culminating in his role as group vice president, clinical development for hematology, gastrointestinal and internal medicine. In this role, Dr. Streck led a team of 50 people and was responsible for thirteen clinical trial programs and regulatory filings across various product lifecycle stages. Prior to Shire plc, Dr. Streck held a variety of medical affairs and commercial roles over five years with Amgen Inc.
Dr. Streck succeeds Alders interim CMO, Eric Carter, M.D., Ph.D., who has been responsible for leading the preparation of the Biologics License Application (BLA) for eptinezumab and ensuring its submission in the first quarter of 2019. Dr. Carter will continue to work closely with the company as a consultant following the transition.
Paul brings extensive experience with regulatory interactions, clinical trial execution, and product lifecycle management, as well as leading medical affairs organizations, and we are delighted to welcome him to the Alder team," said Bob Azelby. This experience, coupled with his deep operating expertise, will be highly valuable as we continue to engage with the U.S. Food and Drug Administration (FDA), including through our planned BLA submission for eptinezumab later this quarter, and to build out our medical and commercial infrastructure in anticipation of the potential launch in the first quarter of 2020.
Im excited to join Alders strong leadership team and have been inspired by the companys commitment to transform the treatment paradigm for millions of patients debilitated by migraine, said Dr. Streck. This is an important time for Alder and for migraine patients. I look forward to working with the Alder team to ensure the successful approval and launch of eptinezumab and the growth of Alder as a leader in novel migraine therapeutics.
A board-certified oral and maxillofacial surgeon, Dr. Streck received his medical degree from Jefferson Medical College. He also holds a doctor of dental medicine degree from Temple Universitys School of Dentistry, and a master`s of business administration from Fuqua School of Business at Duke University.
Eptinezumab is an investigational monoclonal antibody (mAb) discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is designed with high specificity and potent binding for rapid and sustained suppression of calcitonin gene-related peptide (CGRP) ligand. Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alders lead product candidate, eptinezumab, is a monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) and is currently in late-stage clinical development for the prevention of migraine. Unlike other CGRP inhibitors, eptinezumab was specifically designed as an infusion therapy to address significant patient need. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention. For more information, please visit www.alderbio.com.
This press release contains forward-looking statements, including, without limitation, statements relating to: the planned BLA submission for eptinezumab; continued engagement with the FDA; the continued build out of Alders commercial infrastructure; the potential approval, launch and commercialization of eptinezumab; and Alders commitment to transform the treatment paradigm for migraine patients and growth as a leader in migraine therapeutics. Words such as will, continue, planned, build, anticipation, potential, look forward, ensure, successful, growth, or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder`s current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder`s ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder`s compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the build of Alders commercialization infrastructure; risks and uncertainties relating to the manufacture and supply of eptinezumab; Alder`s ability to
obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder`s development and commercialization activities; the sufficiency of Alder`s capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Alder`s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2018, which was filed with the Securities and Exchange Commission (SEC) on November 5, 2018, and is available on the SEC`s website at www.sec.gov. Additional information will also be set forth in Alder`s other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder`s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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