U.S. Markets open in 1 hr 37 mins

Alder BioPharmaceuticals® to Showcase 14 New Data Presentations Demonstrating Eptinezumab’s Migraine Prevention and Quality of Life Impact at American Headache Society Meeting

Posters highlight eptinezumab’s impact in chronic and episodic migraine clinical trials, including data on migraine-free months and early, sustained reduction in chronic migraine severity

BOTHELL, Wash., July 08, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that it will present new analyses of efficacy and quality of life data from its clinical trials for eptinezumab at the American Headache Society’s (AHS) 61st Annual Scientific Meeting in Philadelphia, PA being held on July 11-14, 2019. Eptinezumab is an investigational monoclonal antibody delivered by IV administration. It was designed for 100% bioavailability with high specificity and strong binding for rapid, robust and sustained suppression of calcitonin gene-related peptide (CGRP).

At the meeting, more than a dozen presentations related to eptinezumab’s safety and efficacy of response in migraine prevention will be shared, including an analysis of 100% response rates for patients with episodic or chronic migraine who were treated with eptinezumab in the Phase 3 PROMISE-1 and PROMISE-2 clinical trials. Another key presentation will focus on the impact of eptinezumab on migraine severity and quality of life. Additional eptinezumab presentations at the meeting will feature a visual representation of the molecule’s binding properties and further analyses related to safety and quality of life data.

“We’re excited to share new data that reinforces eptinezumab as a significant migraine prevention treatment option that has the potential to help the millions of people with this debilitating and highly symptomatic disease,” said Dr. Paul Streck, chief medical officer of Alder. “We’ve previously presented data on eptinezumab’s efficacy and rapid onset of prevention benefit and these new analyses will show its impact in migraine-free months and improvements in severity and patient-reported outcomes in our clinical trials. We look forward to delivering this important treatment option early next year, if approved, to improve the lives of people living with migraine.”

The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing for eptinezumab in April 2019, and set a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, eptinezumab will be the first-to-market IV therapy for migraine prevention.

Poster and ePoster Presentations:
Friday, July 12, 6:30 a.m. – 5:00 p.m. ET; Presentations: 1:15 p.m. – 2:15 p.m. ET, Hall A at Pennsylvania Convention Center; corresponding ePoster presentations on Saturday, July 13

• 
Poster Number P12: Eptinezumab Reduces the Frequency of Headaches and Migraines in Patients with Episodic or Chronic Migraine: Results from the PROMISE-1 and PROMISE-2 Trials 

- Presenter: Dr. Laszlo L. Mechtler, medical director of Dent Neurologic Institute and chief of neuro-oncology, Roswell Park Cancer Institute as well as professor of neurology and neuro-oncology, State University of New York at Buffalo

• Poster Number P158: An Open-Label Phase 3 TRial to EValuate the Safety of Eptinezumab Administered IntravenousLy in Patients with Chronic Migraine (PREVAIL): Demographics and Baseline Characteristics

- Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society
- E-poster on Saturday, July 13 from 1:25-1:30 p.m. ET

• Poster Number P16: Reduced Impact of Headaches After Migraine Preventive Treatment with Eptinezumab in Patients with Chronic Migraine: Results from the PREVAIL Open-Label Safety Study

- Presenter: Dr. Egilius L.H. Spierings, director and principal investigator, MedVadis Research Corporation

• Poster Number P138: Eptinezumab Significantly Improved Health-Related Quality of Life in Patients with Chronic Migraine in the Open-Label PREVAIL Study

- Presenter: Eric Kassel, Pharm.D., vice president of medical affairs, Alder BioPharmaceuticals
- E-poster on Saturday, July 13 from 1:20-1:25 p.m. ET

• Poster Number P214LB: Chronic Migraine: Establishing a Responder Definition for the HIT-6 Total Score

- Presenter: Carrie R. Houts, Ph.D.; director of psychometrics; Vector Psychometric Group, LLC
- E-poster on Saturday, July 13 from 1:40-1:45 p.m. ET

• Poster Number P216LB: Early and Sustained Reduction in Headache Impact in People with CM After Eptinezumab Treatment: HIT-6 Item Analysis in the Phase 3 PROMISE-2 Trial

- Presenter:  Dr. James McGinley, director of behavioral analytics, Vector Psychometric Group, LLC
- E-poster on Saturday, July 13 from 1:00-1:05 p.m. ET

• Poster Number P218LB: Eptinezumab Reduced the Frequency of Acute Medication Usage in Patients with Episodic or Chronic Migraine

- Presenter: Dr. Stewart Tepper, professor of neurology, Geisel School of Medicine, Dartmouth; director, AHS Scottsdale Headache Symposium and editor-in-chief, Headache Currents
- E-poster on Saturday, July 13 from 1:40-1:45 p.m. ET

• Poster Number P220LB: The Eptinezumab: CGRP Complex Structure and Characterization of the Ligand Binding Interface

- Presenter: Kira Misu, Ph.D., vice president of R&D, Alder BioPharmaceuticals
- E-poster on Saturday, July 13 from 1:00-1:05 p.m. ET

Saturday, July 13, 6:30 a.m. – 5:00 p.m. ET; Presentations: 1:00 p.m. – 2:15 p.m. ET, Hall A at Pennsylvania Convention Center; corresponding ePoster presentations on Saturday, July 13

• Poster Number P17: Eptinezumab Treatment for Migraine Prevention Reduces Migraine Disability in Patients with Chronic Migraine: An Analysis from the PREVAIL Open-Label Safety Study

- Presenter: Dr. Gary Berman, practicing headache specialist and principal investigator, Clinical Research Institute

• Poster Number P125: PREVAIL: An Open-Label Phase 3 TRial to EValuate the Safety of Eptinezumab Administered IntravenousLy in Patients with Chronic Migraine

- Presenter: Dr. Yanyu Song, associate director, clinical operations, Alder BioPharmaceuticals
- E-poster on Saturday, July 13 from 1:35-1:40 p.m. ET

• Poster Number 213LB: Content Validity of the HIT-6 in Migraine Patients: Results of a Systematic Literature Review

- Presenter: Carrie Houts, Ph.D., director of psychometrics, Vector Psychometrics Group
- E-poster on Saturday, July 13 from 1:50-1:55 p.m. ET

• Poster Number 215LB: Eptinezumab Demonstrated Early and Sustained Reductions in HIT-6 Total Score Over Time in Patients with Chronic Migraine in the PROMISE-2 Trial

- Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society
- E-poster on Saturday, July 13 from 1:15-1:20 p.m. ET

• Poster Number 217LB: Migraine-Free Months in Patients with Episodic or Chronic Migraine Treated with Eptinezumab: Results from the PROMISE-1 and PROMISE-2 Trials

- Presenter: Dr. Paul Winner, director of both the Premiere Research Institute and the Palm Beach Headache Center
- E-poster on Saturday, July 13 from 1:15-1:20 p.m. ET

• Poster Number P219LB: Treatment with Eptinezumab Demonstrated Meaningful Improvements in Patients with Chronic Migraine Experiencing a High Frequency of Severe Migraines

- Presenter: Eric Kassel, Pharm.D., vice president of medical affairs, Alder BioPharmaceuticals
- E-poster on Saturday, July 13 from 1:55-2:00 p.m. ET

About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming migraine treatment through the discovery, development and commercialization of novel therapeutic antibodies. The company’s mission is to forever change migraine treatment and give people with migraine their lives back. In 2019, Alder was ranked 19th among the top 100 fastest growing companies in Seattle by Growjo.

Eptinezumab, Alder’s lead product candidate for migraine prevention, is an investigational monoclonal antibody (mAb) that is delivered via IV and designed for 100% bioavailability with high specificity and strong binding for powerful, fast and sustained suppression of calcitonin gene-related peptide (CGRP). If approved by the U.S. Food and Drug Administration, it will be the first-to-market IV therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb designed to inhibit 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 potential approval by the FDA of the BLA for eptinezumab; the continued development of eptinezumab and the development of ALD1910; the clinical, therapeutic and commercial potential of eptinezumab and ALD1910; the belief that eptinezumab has the potential to be an important treatment option; and Alder’s mission to forever change migraine treatment and give people with migraine their lives back. Words such as “will,” ”potential,” “look forward,” “option,” 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 and ALD1910; 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 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 March 31, 2019, which was filed with the Securities and Exchange Commission (SEC) on May 2, 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:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah.mccabe@sternir.com

Media Contact:
Ashley Cadle
TogoRun
310-463-0143
a.cadle@togorun.com