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U.S. Food and Drug Administration Accepts Biologics License Application for Eptinezumab

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BOTHELL, Wash., April 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 that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb), administered intravenously, for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder's lead commercial candidate. The company submitted its BLA on February 21, 2019 and continues to expect to receive a Prescription Drug User Fee Act (PDUFA) action date within 74 days following the submission. If the FDA grants approval of eptinezumab, Alder anticipates a Q1 2020 commercial launch.

"Migraine is far more than a headache, it's a serious neurological disease with a debilitating impact to patients that can lead to other issues including depression, anxiety, and sleep disturbances," said Bob Azelby, Alder's president and chief executive officer. "The FDA's acceptance of our BLA is an important milestone, and the company remains focused on supporting the application review for the first quarterly infusion therapy for patients suffering from episodic and chronic migraine. In the meantime, we continue to make substantial progress scaling our medical, manufacturing and commercial infrastructure to enable a successful launch of eptinezumab for migraine patients, if approved."

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, an open-label safety study, a pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages. The safety profile of eptinezumab was similar to placebo across all treatment arms in the Phase 3 studies. The most common adverse events across the studies was nasopharyngitis. 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 are planned for publication in 2019.  

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 30 mg) 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 include at least 75 percent and at least 50 percent responder rates assessed through 12 weeks, and proportion of patients experiencing migraine on the day following administration.  In June 2017, Alder announced that eptinezumab met the primary endpoints and key secondary endpoints in PROMISE 1.

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 the 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 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 assessed through 12 weeks, 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.

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 strong binding affinity 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 an investigational monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) for the prevention of migraine. If approved by the U.S. Food and Drug Administration, eptinezumab will be the first infusion therapy for migraine prevention. 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 expected receipt of a PDUFA date; the potential approval by the FDA of the BLA for eptinezumab; the anticipated commercial launch of eptinezumab and Alder's progress with scaling its medical, manufacturing and commercial infrastructure to enable a successful launch of eptinezumab; Alder's focus on  transforming the treatment paradigm for migraine patients; and the development of ALD1910. Words such as "will," "continues," "expect," "anticipates," "remains," "continue," "progress," "enable," 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 develop and advance programs in its pipeline; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on February 25, 2019, 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

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