Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) Files An 8-K Entry into a Material Definitive Agreement

Item1.01 Entry into a Material Definitive Agreement

Lease Amendment

On November 18, 2016, Alder BioPharmaceuticals, Inc. (Alder)
entered into a Fifth Amendment to Lease (the Fifth Amendment)
with KBS North Creek LLC, as successor-in-interest to RREEF
American REIT II Corp. KK, to amend certain provisions of the
Lease by and between Alder and RREEF American REIT II Corp. KK,
dated August 5, 2005, as previously amended (the Original Lease).

The Fifth Amendment (i) extends the term of the Original Lease by
an additional 60 months through July 31, 2023, (ii)expands the
premises covered by the Original Lease, beginning on or about
February 1, 2017, (iii) provides Alder with an option for future
expansion, and (iv) changes the rental rate, which together with
the term extension, results in incremental rent obligations of an
aggregate of $7.8 million for the duration of the Original Lease,
as amended by the Fifth Amendment.

The foregoing description of the Fifth Amendment is a summary, is
not complete, and is qualified in its entirety by the terms and
conditions of the actual Fifth Amendment, which is attached
hereto as Exhibit 10.1 and incorporated herein by reference.

Item 8.01 Other Events.

Decision in Opposition Proceeding in European Patent
Office

Alder is reporting an outcome in its opposition to Labrys
Biologics Inc.s (owned by Teva Pharmaceutical Industries Ltd.)
European Patent No. 1957106 B1. The patent at issue, granted in
October 2013, originally contained claims relating to calcitonin
gene-related peptide (CGRP) antagonist antibodies and the use of
such CGRP antagonist antibodies in human therapy for the
prevention or treatment of CGRP-associated vasomotor symptoms
such as migraine and hot flush. The opposition to the patent was
filed in July 2014 by both Alder and Eli Lilly and Company. The
opposition asserts that the patent be revoked in its entirety
because the patents broad claims do not meet the requirements for
patentability under the European Patent Convention. In an oral
proceeding held in Munich, Germany on November 18, 2016, the
Opposition Division (OD) of the European Patent Office (EPO)
issued a ruling revoking all claims in the patent relating to
CGRP antagonist antibodies and maintaining but narrowing claims
relating to the use of CGRP antagonist antibodies in human
therapy to the prevention or treatment of headache such as
migraine and cluster headache. The written decision consistent
with the oral ruling is expected within a few weeks.

The initial decision by the EPO affirms Alders right to continue
clinical development of ALD403, Alders drug candidate for the
prevention of migraine, and has no impact on Alders plan to
submit a Biologics License Application (BLA) for ALD403 with the
U.S. Food and Drug Administration (FDA) in the second half of
2018 and to commercialize ALD403 in the United States. The ODs
decision is subject to appeal to the EPOs Technical Board of
Appeal by the parties to the proceeding. Alder plans to pursue an
appeal based on its continued firm belief that the patent claims
that were maintained and narrowed were nevertheless improperly
granted by the EPO and upheld by the OD, and should be revoked in
its entirety on appeal for the reasons set forth in the
opposition. The OD decision has no binding effect on the U.S.
Patent and Trademark Offices patentability determination of
claims in granted or pending Labrys patent applications in the
United States which correspond to the opposed European patent or
impact on Alders ability to take action seeking to invalidate
such granted or pending U.S. applications.

For the reasons set forth in Alders opposition, Alder continues
to firmly believe the patent should be revoked in its entirety.
However, Alder cannot predict the specific timing or outcome of
events or matters discussed in this Current Report on Form 8-K,
or the impact of the November 18, 2016 decision on Alders
business. Because of the inherent uncertainty in intellectual
property legal proceedings, the opposition proceeding and appeal
may not ultimately be resolved in Alders favor regardless of
Alders perception of the merits. If Alder loses such a proceeding
or appeal, Alder may not be able to engage in commercialization
and related activities for ALD403 for the treatment of migraine
in the European countries that are members of the European Patent
Organisation without obtaining a license. However, such license
may not be available on commercially reasonable terms or at all,
and if granted may be non-exclusive, thereby giving Alders
competitors freedom to operate in these countries. If Alder is
found to infringe the patent in these European countries, Alder
could be forced, including by court order, to cease
commercialization and related activities for ALD403 in such
countries and possibly be found liable for monetary damages and
attorneys fees.

This Current Report on Form 8-K contains forward-looking
statements, including, without limitation, statements relating
to: Alders plan to appeal the referenced decision of the OD;
Alders belief that the referenced patent should be revoked in its
entirety and Alders belief in the merits of the opposition;
future developments in the opposition of the referenced patent
and Alders expectations with respect thereto; Alders expectation
that the ODs decision will not interfere with the continued
clinical development of ALD403 or Alders plan to submit a BLA for
ALD403 with the FDA in the second half of 2018; Alders belief
that the OD decision has no impact Alders ability to take action
seeking to invalidate granted or pending Labrys U.S. patent
applications; and the potential future impact on Alder and its
business as a result of the opposition and appeal. Words such as
expect, can, plans, continues, believe, predict, may, could, 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 Current Report on Form 8-K are based upon Alders 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 inherent uncertainty in legal
proceedings involving intellectual property and the possibility
that such proceedings may result in outcomes that are unfavorable
to Alder; the timing, scope and costs of legal proceedings
involving intellectual property; Alders ability to obtain and
protect intellectual property rights, and operate without
infringing on the intellectual property rights of others; the
potential failure of ALD403 to demonstrate safety and efficacy in
clinical testing; Alders ability to conduct clinical trials and
studies of ALD403 sufficient to achieve a positive completion;
the availability of data at the expected times; the clinical,
therapeutic and commercial value of ALD403; risks and
uncertainties related to regulatory application, review and
approval processes and Alders compliance with applicable legal
and regulatory requirements; risks and uncertainties relating to
the manufacture of ALD403; the uncertain timing and level of
expenses associated with the development of ALD403; the
sufficiency of Alders capital and other resources; market
competition; changes in economic and business conditions; and
other factors discussed under the caption Risk Factors in Alders
Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2016, which was filed with the Securities and
Exchange Commission (SEC) on October 27, 2016, and is available
on the SECs website at www.sec.gov. Additional information will
also be set forth in Alders other reports and filings it will
make with the SEC from time to time. 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. 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 Alders expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits

About Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR)

Alder Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company discovers, develops and focuses to commercialize therapeutic antibodies with the potential to transform current treatment paradigms. The Company has developed an antibody platform designed to select antibodies that have the potential to maximize efficacy, as well as speed of onset and durability of therapeutic response. The Company’s pipeline includes ALD403, Clazakizumab and ALD1613. ALD403 is the Company’s monoclonal antibody targeted to calcitonin gene-related peptide (CGRP) for migraine prevention. Clazakizumab is a monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6 (IL-6), and is in development for both rheumatoid arthritis (RA) and psoriatic arthritis (PsA). ALD1613 is a monoclonal antibody that inhibits Adrenocorticotropic Hormone (ACTH), and is being developed for the treatment of Cushing’s disease. It is also developing ALD403 program for migraine prevention.

Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) Recent Trading Information

Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR) closed its last trading session down -2.30 at 26.45 with 1,024,464 shares trading hands.