Alder BioPharmaceuticals, Inc. (ALDR) to Present New Data Further Highlighting Eptinezumab’s Efficacy Profile

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Alder BioPharmaceuticals® to Present New Data Further Highlighting Eptinezumab’s Efficacy Profile for Migraine Prevention at American Headache Society Meeting

Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that it will present updated data from the PROMISE 1 and PROMISE 2 phase 3 clinical trials for eptinezumab, Alder’s lead investigational product candidate for migraine prevention, at the upcoming American Headache Society (AHS) annual scientific meeting at the Marriott Marquis in San Francisco, CA (June 28 – July 1, 2018).

Eptinezumab data will be presented in multiple late-breaking sessions, platform presentations and poster presentations, and will debut efficacy data from PROMISE 2 for chronic migraine patients who received two quarterly infusions of eptinezumab. Key outcomes from PROMISE 2 will include monthly migraine days, early onset of activity and responder rates (≥50, ≥75 and 100 percent) after two quarterly infusions. The presentations also will include new year-long data from PROMISE 1 evaluating eptinezumab in episodic migraine patients, as well as outcomes of the Short-Form Health Survey Scores in PROMISE 2, which assess quality of life.

“At Alder, we are committed to advancing the treatment paradigm for migraine prevention for patients whose quality-of-life is severely impacted by this debilitating condition,” said Robert Azelby, chief executive officer of Alder. “Our new and compelling efficacy and outcomes data showing a large percentage of patients achieving Day One reductions in migraine risk that is sustained through 12 weeks and also further improves after two or more quarterly infusions, continues to support eptinezumab’s potential to be a meaningful, new treatment option for migraine patients.”

Late-Breaking Studies, Friday, June 29:

Session PF110LB: Display: 6:30 am – 5:00 pm PT; Presentation: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

  • Eptinezumab for Prevention of Chronic Migraine (CM): Results of 2 Quarterly Intravenous Infusions in the Phase 3 PROMISE-2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy‒2) Trial
    • Presenter: Dr. Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine

Session PF108LB: Display: 6:30 am – 5:00 pm PT; Presentation: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

  • Eptinezumab Results for the Prevention of Episodic Migraine Over One Year in the PROMISE-1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy‒1) Trial
    • Presenter: Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center, Thomas Jefferson University

Platform Presentations, Saturday, June 30:

Session IOR03: 8:20 am – 8:30 am PT, Yerba Buena Ballroom

  • Eptinezumab Reduced Migraine Activity and Achieved High Migraine Responder Rates over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
    • Presenter: Dr. Paul Winner, director of both the Premiere Research Institute and the Palm Beach Headache Center in West Palm Beach, FL

Session IOR04: 8:30 am – 8:40 am PT, Yerba Buena Ballroom

  • Eptinezumab Achieved Meaningful Reductions in Migraine Activity as Early as Day 1: PROMISE-2 (PRevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) Phase 3 Trial in Chronic Migraine
    • Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society

Poster Presentations: 
All posters displayed Friday, June 29, 6:30 am – 5:00 pm PT; Presentations: 1:15 pm – 2:15 pm PT, Yerba Buena Ballroom

  • PF06: Migraine Activity Reductions with Eptinezumab Were Associated with Improvements in Short-Form Health Survey Scores Most Affected by Migraine: Results from Phase 3 PROMISE-2 Trial in Chronic Migraine
    • Presenter: Dr. Joel Saper, founder and director, Michigan Headache and Neurology Institute
  • PF34: Baseline Population Characteristics of PROMISE-2: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Eptinezumab for Prevention of Chronic Migraine
    • Presenter: Dr. Egilius Spierings, director and principal investigator, MedVadis Research Corporation
  • PF10: Eptinezumab Reduced Migraine Hours and Severity, Which Were Accompanied by Improved HIT-6 Scores, over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
    • Presenter: Dr. Timothy Smith, medical director, Mercy Health Research, Mercy Medical Group
  • PF02: A Phase 3 Study to Evaluate Eptinezumab for the Preventive Treatment of Chronic Migraine: Results of the PROMISE 2 (PRevention of Migraine via Intravenous Eptinezumab Safety and Efficacy‒2) Trial
    • Presenter: Dr. Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine
  • PF20: Eptinezumab Reduced Migraine Frequency and Triptan/Ergotamine Use Over Weeks 1‒12, and Improved HIT-6 Scores at Months One and Three: Results From the Phase 3 PROMISE-2 Trial in Chronic Migraine
    • Presenter: Dr. Stephen Silberstein, professor of neurology and director, Jefferson Headache Center, Thomas Jefferson University

E-Poster Presentations: 
All e-posters displayed Friday, June 29, 1:55 pm – 2:00 pm PT; Exhibit Hall

  • Room 3: Eptinezumab Reduced Migraine Hours and Severity, Which Were Accompanied by Improved HIT-6 Scores, over Weeks 1‒12: Results from the Phase 3 PROMISE-2 Trial in Chronic Migraine
    • Presenter: Dr. Timothy Smith, medical director, Mercy Health Research, Mercy Medical Group
  • Room 2: A Phase 3 Study to Evaluate Eptinezumab for the Preventive Treatment of Chronic Migraine: Results of the PROMISE-2 (PRevention of Migraine via Intravenous Eptinezumab Safety and Efficacy‒2) Trial
    • Presenter: Dr. Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine

About Eptinezumab 
Eptinezumab is an investigational monoclonal antibody discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is the only potent and selective anti-CGRP mAb administered by quarterly infusion for migraine prevention, delivering 100% bioavailability to immediately inhibit CGRP.1 Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.

About Eptinezumab PROMISE Clinical Trial Program
PROMISE 1 (PRevention OMigraine 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, 888 patients were randomized to receive 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 75 percent and 50 percent responder rates over weeks 1-12, reduction in the proportion of patients experiencing migraine on the day following administration, and those assessed through week 24 include 75 percent and 100 percent responder rates. 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.

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