BOTHELL, Wash., Sept. 21, 2016 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the appointment of Nancy L. Boman, M.D., Ph.D. as senior vice president of regulatory affairs and pharmacovigilance. Dr. Boman will be responsible for developing and implementing the regulatory strategy and pharmacovigilance program of ALD403 for migraine prevention as it advances through pivotal trials and toward a planned Biologic License Application (BLA) with the U.S. Food and Drug Administration (FDA).
“We are delighted to welcome Nancy to our management team as we continue to expand the team to support the advancement of ALD403,” said Randall C. Schatzman, Ph.D., president and chief executive officer. “Nancy has an extensive background in regulatory affairs with multiple successful marketing applications in the U.S. and abroad, including biologics applications. We look forward to leveraging her skills and deep experience as we progress ALD403 toward an FDA submission and our goal of marketing a best-in-class migraine prevention antibody therapy.”
Dr. Boman has 25 years of pharmaceutical industry experience focused in clinical development and regulatory affairs, including more than ten successful drug marketing application filings. She joins Alder from Cell Therapeutics Inc., where she most recently served as the senior vice president of clinical development and regulatory affairs. Dr. Boman’s prior senior clinical development and regulatory affairs experience includes positions at Genentech, Amgen and QLT. She holds a bachelor’s degree, a medical degree and a Ph.D. in biochemistry from the University of British Columbia in Vancouver.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder's lead pivotal-stage product candidate, ALD403, is being evaluated for migraine prevention. ALD403 is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder's third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of ALD403; future regulatory filings; and the anticipated commercialization of ALD403. Words such as "continues," “advance,” “look forward,” “progress,” “goal,” 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 ALD403 to demonstrate safety and efficacy in clinical testing; Alder’s ability to conduct clinical trials of ALD403 sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of ALD403; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; the uncertain timing and level of expenses associated with the development of ALD403; 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 June 30, 2016, which was filed with the Securities and Exchange Commission (SEC) on July 26, 2016, 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.