Alder Submits BLA to U.S. FDA for Eptinezumab
Alder BioPharmaceuticals® Submits Biologics License Application to the U.S. Food and Drug Administration for Eptinezumab
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
BOTHELL, Wash., Feb. 22, 2019 (GLOBE NEWSWIRE) — Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch.
“Completing the BLA submission of eptinezumab is a significant milestone for Alder that underscores our continued mission to provide new treatment options for the millions of patients living with the debilitating effects of migraine,” said Bob Azelby, chief executive officer of Alder. “I’m extremely grateful to all the Alder staff, physicians and other medical professionals who participated in the BLA submission process with a common goal to support patients who are looking for additional preventive treatment options. If approved, eptinezumab will be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective, and sustained suppression of migraine.”
Eptinezumab has been evaluated in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. Top-line results from the PROMISE 1 and PROMISE 2 Phase 3 clinical trials were presented at the American Association of Neurology (AAN) and American Headache Society (AHS) meetings in the second quarter of 2018 and will be published in future peer-reviewed publications.
About Eptinezumab PROMISE Clinical Trial Program
PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (300 mg, 100 mg or 30mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week treatment period. Secondary study endpoints assessed through 12 weeks include at least 75 percent and at least 50 percent responder rates, and proportion of patients experiencing migraine on the day following administration. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance. See the press release for more information.
PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) was a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, patients were randomized and 1,072 received eptinezumab (300 mg or 100 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period. Secondary study endpoints assessed through 12 weeks included proportion of patients experiencing migraine on the day following administration and reduction of migraine prevalence days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6). In January 2018, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 2 with very high statistical significance. See the press release for more information.
Eptinezumab is an investigational monoclonal antibody (mAb) discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is designed with very high specificity and strong binding for rapid, robust, and sustained suppression of CGRP.
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.
This press release contains forward-looking statements, including, without limitation, statements relating to: the potential acceptance and approval by the FDA of the BLA submission for eptinezumab; the potential commercial launch of eptinezumab; the clinical, therapeutic and commercial potential of eptinezumab; Alder’s mission to provide new treatment options; and future publications of eptinezumab results. Words such as “will,” “on track,” “provide,” 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: 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 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.
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Source: Alder BioPharmaceuticals, Inc.
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