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CAMBRIDGE, Mass. & NORTH CHICAGO, Illinois–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of
The European Medicines Agency (EMA) has adopted a favorable opinion
recommending the granting of marketing authorization for ZINBRYTA™
(daclizumab) for the treatment of relapsing forms of
multiple sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is self-administered once a month,
experimental subcutaneous treatment of RMS. ZINBRYTA is also
currently undergoing regulatory review in the United States, Switzerland,
Canada and Australia.
“For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to deliver robust efficacy, manageable safety
profile through patient monitoring and monthly subcutaneous injection
dosage,” said Alfred Sandrock, MD, Ph.D., executive vice president and
Chief Medical Officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) that did not cause large and prolonged immune cells
exhaustion.”
The positive opinion of the CHMP is now sent to the European Commission
(EC), which grants marketing authorizations to
medicines in the European Union. A decision from the EC is awaited
In the coming months.
“Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the favorable opinion issued by the CHMP is a
Critical Milestone Bringing Us Closer to Bringing ZINBRYTA to Patients
Europe,” said Michael Severino, MD, executive vice president, research
and Development and Chief Scientific Officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
Disability progression confirmed over 24 weeks. The review is based on
results of two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg given subcutaneously every four weeks improved results on
key measures of MS activity in MS patients compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of
infections (4% versus 2%), serious skin reactions (2% versus elevations in hepatic transaminases greater than five times the upper value
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound under development for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of
humanized monoclonal antibody that selectively binds to
subunit of the high affinity interleukin-2 (IL-2) receptor (CD25) which is
expressed at high levels on T cells that activate in people with
MRS. ZINBRYTA modulates general immune cell-free IL-2 signaling
exhaustion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogene
Through cutting-edge science and medicine, Biogen discovers, develops
and provides innovative therapies worldwide for people living with
serious, autoimmune and rare neurological diseases. Founded in 1978,
Biogen is one of the oldest independent biotechnology companies in the world
and patients around the world benefit from its leading products in the field of multiple sclerosis and
innovative therapies for hemophilia. For more information, visit www.biogen.com.
follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements on the expected timing of the EC decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements can be identified by words such as
“believe”, “expect”, “may”, “potential”, “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
marketing involve a high degree of risk. Factors that could
cause actual results to differ materially from our current expectations
include the risk of the EC not approving or delaying approval
of ZINBRYTA or not following the CHMP recommendation,
uncertainty of the commercialization success of ZINBRYTA Learn more
detailed information about the risks and uncertainties associated with our
drug development and commercialization activities and related risks
our collaborations with third parties, please see the risk factors
section of our most recent annual or quarterly report filed with the
Security and Exchange Commission. All forward-looking statements speak
as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global research-based biopharmaceutical company founded in
2013 following the separation of Abbott Laboratories. From the company
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and commercialize advanced therapies that address some of the
most complex and serious diseases in the world. In collaboration with his
wholly owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people around the world and markets medicines in more than 170 countries. For
further information about the company and its people, its portfolio and
commitments, go to www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-looking statements
Certain statements contained in this press release may be forward-looking statements.
for the purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe”, “expect”, “anticipate”, “project” and others
expressions, among other things, generally identify
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results
differ materially from those set forth in the forward-looking statements
statements. These risks and uncertainties include, but are not limited
to, intellectual property challenges, competition from other
products, the difficulties inherent in the research and development process,
adverse litigation or government action, and changes in laws and
regulations applicable to our industry.
Additional information on economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations are
disclosed in Section 1A, “Risk Factors”, in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie assumes no obligation to publicly disclose
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Michael P. Boser