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September 7, 2017 at 8:30 AM EDT
Alder BioPharmaceuticals® to Present Data from Eptinezumab Development Program at 18th Congress of the International Headache Society

BOTHELL, Wash., Sept. 07, 2017 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced that eptinezumab, the company's investigational product candidate for migraine prevention, will be the subject of seven scientific presentations at the 18th Congress of the International Headache Society (IHC) being held September 7-10, 2017 in Vancouver, Canada.

The eptinezumab presentations will feature detailed clinical results from Alder's PROMISE 1 Phase 3 clinical trial evaluating patients with frequent episodic migraine, as well as additional data analyses of Alder's Phase 2b clinical trial evaluating patients with chronic migraine, including data of patient-reported outcomes, reduced triptan use and reductions in migraine on the first day post-infusion.

"Physicians today are limited in their ability to meet their migraine patients' treatment needs because preventive therapeutic options take weeks to months to work and have tolerability and/or safety issues, which limits their efficacy potential," said Roger K. Cady, M.D., vice president of neurology of Alder. "We are excited about our data presentations at IHC, which we believe will support the potential benefits of eptinezumab's unique clinical profile and infusion delivery.  These data include prevention benefit day 1 post infusion and an average of 1 in 5 patients with no migraines in any given month. We believe these clinical results may represent a new standard for migraine prevention.  We look forward to sharing our data at IHC."

Eptinezumab is a monoclonal antibody discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is administered quarterly via infusion that allows for 100% of the dose available to selectively and potently inhibit CGRP1. Eptinezumab is currently in Phase 3 studies, including PROMISE 1 and PROMISE 2, to assess its efficacy and safety in migraine prevention. Over 1,600 people have been treated with eptinezumab in clinical trials. 

Abstracts at IHC:

Late-breaking CGRP Monoclonal Antibody Industry Platform Presentations Session:
Friday, Sept. 8, 2017, 7:00 p.m. — 8:00 p.m. PT, East Ballroom C

  • "A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab in Frequent Episodic Migraine Prevention: Primary Results of the PROMISE 1 (Prevention of Migraine via Intravenous eptinezumab Safety and Efficacy 1) Trial"
     • Presenter:  Jeff Smith, M.D., Managing Director, Alder BioPharmaceuticals Limited

Oral Communications — Migraine and Cluster Session:
Saturday, Sept. 9, 2017, 11:00 a.m. — 11:45 a.m. PT, East Ballroom C

  • "A Single Intravenous Administration of ALD403 (Eptinezumab) Reduces Use of Triptans Among Patients with Chronic Migraine"
     • Presenter:  Roger Cady, M.D, V.P. of Neurology, Alder BioPharmaceuticals, Inc.

Poster Presentations:
Friday, Sept. 8, 2017, 11:00 a.m. — 12:00 p.m. PT  Exhibition Hall A

  • Poster: #EP-01-019, "Migraine Preventive Benefits of ALD403 (Eptinezumab) begin in the first 24 Hours Following Intravenous Administration"
     • Presenter:  Peter Goadsby, M.D., NIH/Welcome Trust King's College Research Faculty
     
  • Poster: #PO-01-085, "Rational Design of a Monoclonal Antibody Inhibiting Calcitonin Gene-Related Peptide, ALD403 (Eptinezumab), to Provide Early Onset, High Efficacy, Extended Duration of Action, and Desired Safety for the Prevention of Migraine"
     • Presenter:  Brian Baker, Senior Director, Alder BioPharmaceuticals, Inc.
     
  • Poster: #PO-01-100, "75% Responder Rate Provides Greater Improvement in Domain Scores of the SF-36 Than the Historically Accepted 50% Responder Rate" 
     • Presenter:  Richard Lipton, M.D., Montefiore Headache Center, Albert Einstein College of Medicine
     
  • Poster: #PO-01-199, "Eptinezumab Infusion Associated with Meaningful Reductions in Daily Migraine Activity on Day 1 and Over Weeks 1 Through 4 in Patients with Frequent Episodic Migraine: Results of the PROMISE 1 (Prevention of Migraine via Intravenous eptinezumab Safety and Efficacy 1) Trial"
     • Presenter:  Roger Cady, M.D., V. P. of Neurology, Alder BioPharmaceuticals, Inc.
     
  • Poster: #PO-01-194, "A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab in Frequent Episodic Migraine Prevention: Primary Results of the PROMISE 1 (Prevention of Migraine via Intravenous eptinezumab Safety and Efficacy 1) Trial" 
     • Presenter:  Jeff Smith, M.D., Managing Director, Alder BioPharmaceuticals Limited             

About Migraine2,3,4
Migraine affects 36 million Americans and is considered the 6th most debilitating disease in the world. It is a disabling neurological disease characterized by recurrent episodes of moderate to severe headache accompanied by nausea, vomiting, and sensitivities to light and sound. The occurrence of migraine can be unpredictable with a profound impact on activities of daily living. This disease can last decades, often during what should be the most productive years of patients' lives. Migraine can remit or progress to chronic migraine over time and persist as chronic migraine for years or decades, but it commonly oscillates between periods of frequent episodic and chronic migraine. Current preventive treatments for migraine fail to meet the needs of most patients and there is a significant need for new, effective, and well-tolerated treatment options.

About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company committed to transforming the treatment paradigm for patients with migraine and other serious neurological or inflammatory conditions. Leveraging its pioneering monoclonal antibody technologies, Alder discovers and develops novel therapeutic antibodies designed to deliver highly differentiated, best-in-class clinical profiles. Alder's lead pivotal-stage product candidate, eptinezumab, is being evaluated for migraine prevention. Eptinezumab is a monoclonal antibody administered quarterly via infusion that allows for 100% of the dose available to selectively and potently inhibit the calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder's third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab; the limitations of existing preventive migraine treatment options and the need for new effective preventive migraine treatment options; and the impact of the data and results presented at IHC, including the belief that the referenced results may represent a new standard for migraine prevention. Words such as "will," "needs," "potential," "believe," "support," "benefits," "may," "look forward," 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, 2017, which was filed with the Securities and Exchange Commission (SEC) on August 8, 2017, 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.

References

  1. Baker B, Schaeffler B, Cady R, et al. Rational design of a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide, ALD403 (Eptinezumab), intended for the prevention of migraine. Poster presented at: American Academy of Neurology (AAN) 2017 Annual Meeting. April 22-28, 2017; Boston, MA.
  2. Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed June 17, 2017.
  3. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015; 55(S2):103-122.
  4. Bigal ME, Krymchantowski AV, Lipton RB. Barriers to satisfactory migraine outcomes. What have we learned, where do we Stand? Headache. 2009; 49(7):1028—1041.
Media Contacts: 
Jamie Moser / Aura Reinhard / Aiden Woglom
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449 

Investor Relations Contact:
David Walsey
Alder BioPharmaceuticals
(425) 408-8032
ir@alderbio.com