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Alder BioPharmaceuticals Announces Positive Results From Pharmacokinetic Comparability Study for Eptinezumab
Globe Newswire 23-Oct-2018 8:00 AM
BOTHELL, Wash., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Alder Biopharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced positive results from a comparative pharmacokinetic (PK) study intended to support the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Eptinezumab is Alder's lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP).
"We are pleased that the PK study has met our objective of demonstrating the comparability of eptinezumab," said Dr. Eric Carter, interim chief medical officer of Alder. "These positive results, combined with our chemistry, manufacturing, and controls (CMC) and clinical data packages, comprise what we believe will be a high-quality Biologics License Application (BLA) submission. We remain on track to submit our BLA with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019."
The PK study (ALD403-CLIN-014) was designed to confirm that the planned commercial supply of eptinezumab had a comparable pharmacokinetic profile to the eptinezumab that was utilized in Alder's clinical trials. Comparative PK profiles were demonstrated between the test and reference products; both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability. Further, the test and reference products were well-tolerated with a similar adverse event profile, and this safety profile was consistent with what has previously been reported for eptinezumab.
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 commercial supply of eptinezumab; and the quality of and timing for the planned BLA submission with the FDA. Words such as "planned," "pleased," "believe," "on track" 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 manufacture 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 June 30, 2018, which was filed with the Securities and Exchange Commission (SEC) on August 7, 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
