BOTHELL, Wash., June 29, 2016 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the appointment of Timothy M. Whitaker, M.D. as chief medical officer. Dr. Whitaker will provide strategic oversight of Alder’s clinical development pipeline and will also be responsible for clinical operations and medical and regulatory affairs. He will play a fundamental role in the clinical development 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 very privileged to welcome Tim to Alder as our chief medical officer,” said Randall C. Schatzman, Ph.D., president and chief executive officer. “He is an accomplished executive responsible for establishing the strategic direction of clinical portfolios as well as achieving numerous global regulatory approvals of innovative therapeutics in the neuroscience space. Tim’s years of experience as a treating physician along with his extensive and deep experience in late stage drug development will enable him to build on Alder’s momentum to push ALD403 across the finish line for the prevention of chronic and frequent episodic migraine. His depth of knowledge will be invaluable as we continue our PROMISE 1 pivotal trial, initiate our second pivotal trial later this year, PROMISE 2, and plan and prepare a BLA submission with the FDA.”
Dr. Whitaker brings 20 years of experience in the pharmaceutical industry leading and managing global clinical development programs, including the strategic direction of multiple neuroscience clinical programs while achieving numerous global regulatory approvals. He joins Alder from Shire plc where he has held clinical development positions of increasing responsibility since 2004, most recently as the vice president and neuroscience therapeutic area head of global clinical development. During his tenure, he played a key role in developing the company as a world leader in specialty pharmaceuticals. From 1996 to 2004, Dr. Whitaker held the positions of associate director, director and senior director of clinical research and development, neuroscience divisions, at Wyeth. Prior to that, he held a variety of teaching and clinical appointments at the University of Vermont College of Medicine and the Medical Center Hospital of Vermont, including Associate Professor of Psychiatry and Director of the Psychopharmacology Clinic. He holds a bachelor’s degree from Duke University in Durham, N.C., and a medical degree from Wake Forest University School of Medicine in Winston-Salem, N.C. He completed a residency in psychiatry and a fellowship in clinical psychopharmacology at the Medical Center Hospital of Vermont in Burlington.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. ALD403, Alder's lead pivotal-stage product candidate being evaluated for migraine prevention, is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide. Alder's second program, ALD1613, targets adrenocorticotropic hormone and is intended for the treatment of congenital adrenal hyperplasia and Cushing's disease. Clazakizumab, Alder’s third program, is a monoclonal antibody candidate designed to block 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 and ALD1613; the initiation of future clinical trials and studies; and future regulatory filings. Words such as “continues,” “support,” “will,” “toward,” “advances,” “planned,” “enable,” “initiate,” “prepare,” “potential,” “intended,” 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 and ALD1613 to demonstrate safety and efficacy in clinical testing; the availability of data at the expected times; the clinical, therapeutic and commercial value of ALD403 and ALD1613; risks and uncertainties related to regulatory review and approval processes and Alder's compliance with applicable legal and regulatory requirements; and other factors discussed under the caption "Risk Factors" in Alder's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on April 28, 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.