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Alder BioPharmaceuticals® Announces Second Quarter 2017 Financial and Operating Results

– Positive top-line PROMISE 1 study results further support eptinezumab’s unique clinical profile –

– $161.5 million from recent public offering expected to enable continued advancement of eptinezumab through pivotal studies, a planned Biologics License Application and achievement of other key activities –

– Conference call set for 5 p.m. EDT today –

BOTHELL, Wash., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced financial results for the second quarter ended June 30, 2017, and provided a corporate update.

“Migraine is a debilitating disease in which current preventative treatment options fail to meet the needs of severe migraine patients. There is a significant market need for new effective treatment options that we believe can be served by eptinezumab, our investigational migraine prevention candidate and one of a new class of anti-CGRP migraine treatments in development,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “We were pleased to report positive top-line results from PROMISE 1, our first pivotal trial for eptinezumab, during the second quarter, which builds upon the robust clinical data we have observed to date. We believe that eptinezumab’s highly competitive and differentiated profile, coupled with the fact that it is the only anti-CGRP migraine treatment administered by infusion in development, will provide a distinct commercial advantage for Alder in the emerging CGRP-directed treatment market. We believe that this would translate to a U.S. market opportunity for eptinezumab infusion therapy, if approved, in the range of approximately $1.5 to $2.0 billion. With our balance sheet enhanced by our recently completed public offering and our disciplined spending plan, we are well-positioned to continue advancing eptinezumab and our goal of transforming the treatment of migraine.”

Recent Corporate Highlights

Eptinezumab – Pivotal-stage novel monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) for the prevention of migraine

  • Reported top-line three and six month results from the PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) Phase 3 pivotal clinical trial on June 27, 2017. PROMISE 1 is evaluating the safety and efficacy of eptinezumab administered via infusion once every 3 months in 888 patients with frequent episodic migraine in the United States. The results demonstrated:
    Eptinezumab met the primary endpoint: highly statistically significant reductions in monthly migraine days from baseline through three months;
    Rapid speed to clinical benefit: a statistically significant >50% reduction in the proportion of patients experiencing a migraine on Day 1 post dose;
    Statistically significant efficacy responses observed at all key time points: ~ 1/3 of patients attained a >75% reduction in migraine days through 1 month and sustained through 3 months (300mg dose);
    Migraine free relief: average 1 in 5 patients had 100% response (i.e., no migraines) in any given month (reduction from a baseline of >8 mean migraine days/month); and
    Safety profile similar to placebo: consistent with previously reported eptinezumab studies.
  • Completed public offering of common stock on July 18, 2017 resulting in net proceeds to Alder of approximately $161.5 million, after underwriting discounts, commissions and estimated offering expenses.
  • Presented additional data in June 2017 at the 59th Annual Scientific Meeting of the American Headache Society from Alder’s eptinezumab program, including additional positive data from the Phase 2b trial of eptinezumab for the prevention of chronic migraine and information describing the rational design objectives and selection of attributes that are important for supporting the desired clinical profile of a migraine prevention therapy.
  • In June 2017, submitted Alder’s statement setting out the grounds of appeal with respect to the decision of the European Patent Office Opposition Division to maintain certain patent claims granted to Teva.

Upcoming Eptinezumab Milestones Expected...