Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) Files An 8-K Other Events

Item8.01

On June27, 2017, Alder BioPharmaceuticals, Inc. (the Company)
announced that eptinezumab met the primary and key secondary
endpoints in the Companys PRevention Of
Migraine via Intravenous ALD403 Safety and
Efficacy (PROMISE 1) clinical trial. This Phase 3 pivotal
clinical trial is evaluating the safety and efficacy of
eptinezumab administered at three dose levels (300mg, 100mg and
30mg) and placebo via infusion once every 12 weeks for one year
in approximately 900 patients with frequent episodic migraine.

The primary endpoint, demonstrating statistically significant
reductions in monthly migraine days from baseline (average of 8.6
days) over weeks 1 through 12 was 4.3 monthly migraine days for
300mg (p=0.0001) and 3.9 days for 100mg (p=0.0179) compared to an
average 3.2 days for placebo. The 30mg dose level was not
formally tested as per the prespecified statistical analysis
plan.

Secondary endpoints evaluating time points through the first
quarterly dose include:

Secondary endpoints demonstrated responses that were improved
through the second quarterly dose period, and include:

The observed safety profile in this study to date was similar to
placebo. Both the safety profile and the placebo rates were
consistent with previously reported eptinezumab studies. Full
safety data will be available at the end of the study.

The statistical significance of the PROMISE 1 results for each
dose level across endpoints was assessed in a hierarchy set forth
in a prespecified statistical analysis plan (generally assessing
the 300mg dose level for a group of endpoints, 100mg dose level
for a group of endpoints and 30mg dose level for a group of
endpoints in sequence). Since the result for the 100mg dose level
for the 75% reduction in monthly migraine days over weeks 1
through 12 endpoint was not statistically significant, the 30mg
dose level was not formally tested per the statistical analysis
plan.

Additional results, including future analysis of additional
secondary endpoints, from the trial are expected to be presented
at future medical meetings and published in peer-reviewed medical
journals.

This Current Report on Form 8-K contains forward-looking
statements, including, without limitation, statements relating
to: the continued development and clinical, therapeutic and
commercial potential of eptinezumab; the availability of clinical
trial data; and future data presentations and publications. Words
such as will, believes, future, expected, or other similar words
or expressions, identify forward-looking statements, but the
absence of these words or expressions 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 Current Report on Form 8-K are based upon the Companys
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; the availability of data at the expected times;
the clinical, therapeutic and commercial value of eptinezumab;
risks and uncertainties related to regulatory review and approval
processes and the Companys compliance with applicable legal and
regulatory requirements; the uncertain timing and level of
expenses associated with the development of eptinezumab; the
sufficiency of the Companys capital and other resources; market
competition; changes in economic and business conditions; and
other factors discussed under the caption Risk Factors in the
Companys Quarterly Report on Form 10-Q for the quarter ended
March31, 2017, which was filed with the Securities and Exchange
Commission (SEC) on April27, 2017, and is available on the SECs
website at www.sec.gov, and in the Companys other filings with
the SEC. The forward-looking statements made in this Current
Report on Form 8-K speak only as of the date of this Current
Report on Form 8-K. The Company 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 the Companys
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.