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, Alder’s 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) plc’s 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 Alder’s 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.”
“I’m excited to join Alder’s strong leadership team and have
been inspired by the company’s 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 University’s
School of Dentistry, and a master's of business administration from
Fuqua School of Business at Duke University.
About Eptinezumab
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. Alder’s 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.
Forward-Looking Statements
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 Alder’s commercial infrastructure; the
potential approval, launch and commercialization of eptinezumab;
and Alder’s 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 Alder’s 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.
Investor Relations Contact:
Michael Schaffzin Stern Investor Relations, Inc. 212-362-1200
michael@sternir.com
Media Contact:
Ashley Cadle TogoRun 310-463-0143 a.cadle@togorun.com
All trademarks, trade names or service marks appearing in this
press release are the property of their respective owners.
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