Alder BioPharmaceuticals® to Present New Phase 3 Migraine Prevention Data for Eptinezumab at the 70th Annual American Academy of Neurology Meeting

PROMISE 2 Phase 3 study selected for Emerging Science clinical trials plenary presentation session on April 24, 2018

| Quelle: Alder BioPharmaceuticals, Inc. Alder BioPharmaceuticals, Inc.

BOTHELL, Wash., April 18, 2018 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that it will present new Phase 3 data for eptinezumab, Alder's lead investigational product candidate for migraine prevention, at the 70th Annual American Academy of Neurology Meeting (AAN) in Los Angeles being held April 21-27, 2018.

Eptinezumab will be the subject of eight scientific presentations. These will include new data from Alder’s PROMISE 1 Phase 3 clinical trial in episodic migraine patients following the third and fourth quarterly infusions (i.e., 12-month data) and improvement in patients’ quality of life measures following a single quarterly infusion. Data from the Company’s PROMISE 2 Phase 3 clinical trial in chronic migraine patients has also been selected for one of AAN’s two plenary presentation sessions on Emerging Science clinical trials.

“We are excited to present data from our PROMISE 1 and PROMISE 2 clinical studies at AAN, which further support eptinezumab’s differentiated clinical profile and its rapid, effective and sustained migraine prevention benefits,” said Roger K. Cady, M.D., Alder’s Vice President of Neurology. “There is a high unmet need for new treatment options to treat the millions of patients that continue to struggle with the burden of migraine. Eptinezumab’s consistent and predictable results across both trials support its potential to be a meaningful treatment option for the most severely impacted of these patients and Alder’s goal to advance the treatment paradigm for migraine prevention.”

Eptinezumab is an investigational monoclonal antibody targeting calcitonin gene-related peptide (CGRP) for migraine prevention. Eptinezumab’s mAb design, combined with delivery via quarterly infusion, allows for strong and immediate inhibition of CGRP biology.1 Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.

Oral Presentations:

Clinical Trials Plenary Presentation

Session: Emerging Science
Tuesday, April 24, 2018, 11:00 a.m. – 11:15 a.m. PT, Concourse Hall 152-153

  • A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 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 of the Montefiore Headache Center, Albert Einstein College of Medicine                    

Platform Presentations

Session S20: “Best of” Session: Headache Scientific
Tuesday, April 24, 2018, 8:00 a.m. – 8:08 a.m. PT, Convention Center – 515 B
             

  • Primary Results of PROMISE 1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) Trial: a Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for Prevention of Frequent Episodic Migraines.
    • Presenter: Dr. Stephen Silberstein, Professor of Neurology and Director of the Jefferson Headache Center at Thomas Jefferson University

             
Session S32: Headache: Therapeutics Scientific
Wednesday, April 25, 2018, 1:12 p.m. – 1:24 p.m. PT, Convention Center – 402 AB
             

  • Increased Migraine-Free Intervals With Eptinezumab Were Associated With Improved Health-Related Quality-of-Life Outcomes Through Week 12: Results From the Phase 3 PROMISE 1 Trial.
    • Presenter: Dr. Richard Lipton, Director of the Montefiore Headache Center, Albert Einstein College of Medicine

Poster Presentations:
             
Wednesday, April 25, 2018 - 11:30 a.m. – 7:00 p.m. PT, Convention Center – West Exhibit Hall

  • P4 092: Eptinezumab Achieved Meaningful Reductions in Migraine Activity Within 24 Hours That Were Sustained Through Week 12: Results From PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) Phase 3 Trial.
    • Presenter: Dr. Timothy Smith, Medical Director of Mercy Health Research, Mercy Medical Group
       
  • P4 108: Repeat Infusions of Eptinezumab Associated With Greater Migraine Reductions and Longer Migraine-Free Intervals: Results From the Phase 3 PROMISE 1 Trial.
    • Presenter: Dr. Egilius Spierings, Director and Principal Investigator, MedVadis Research Corporation
       
  • P4 091: Eptinezumab Reduced Migraine Frequency, Duration, and Pain Intensity Through Week 24: Results From the Phase 3 PROMISE 1 Trial.
    • Presenter: Dr. Peter McAllister, Director of the New England Center for Neurology and Headache
       
  • P4 470 (Emerging Science): Eptinezumab Achieved Meaningful Reductions in Migraine Activity As Early As Day 1 and Were Sustained Through Week 12: Results From PROMISE 2 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) Phase 3 Trial in Chronic Migraine.
    • Presenter: Dr. David Kudrow, Director of the California Medical Clinic for Headache
       
  • P4 471 (Emerging Science): 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 of the Jefferson Headache Center at Thomas Jefferson University

About Migraine
Migraine affects 36 million Americans2 and, worldwide, is considered the sixth-leading cause of days with disability3 and the third-leading cause of disability of people under the age of 50.4 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.2 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 most patients discontinue use within 6 months to 1 year due to lack of efficacy and/or side effects.5,6 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 as potentially the first-to-market migraine prevention infusion therapy. Eptinezumab is a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide (CGRP), which is believed to play a key role in mediating and initiating 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 unmet need for treatment options; the belief that eptinezumab has the potential to be a meaningful treatment option; and Alder’s goal to advance the treatment paradigm for migraine prevention. Words such as “will,” “support,” “need,” “potential,” “option,” “goal,” 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 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.

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 the American Academy of Neurology (AAN) 2017 Annual Meeting.
  2. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015; 55(S2):103-122.
  3. Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed April 16, 2018.
  4. Steiner, TJ, Stovner, LJ, & Vos, T. GBD 2015: Migraine is the third cause of disability in under 50s. The Journal of Headache and Pain, 2016;17(1).
  5. 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.
  6. Hepp, Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 2015;35(6):477-88.

             
Investor Relations Contact:                                        

Ashwin Agarwal                                                                                                                               
Vice President, Corporate Strategy                                                         
Alder Biopharmaceuticals, Inc.
425-408-8567
aagarwal@alderbio.com

Michael Schaffzin
Stern Investor Relations, Inc.
212-362-1200
michael@sternir.com

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