NORTH CHICAGO, Ill.,
June 26, 2020 /PRNewswire/
-- Allergan, an AbbVie Company (NYSE: ABBV), and Molecular
Partners (SIX: MOLN), a clinical-stage biotechnology company
developing a new class of custom-built protein therapeutics known
as DARPin® therapeutics, today announced that the U.S. Food and
Drug Administration (FDA) has issued a Complete Response Letter to
the Biologics License Application (BLA) for Abicipar pegol, a
novel, investigational DARPin® therapy for patients with
neovascular (wet) age-related macular degeneration (nAMD).
The letter from the FDA indicates that the rate of intraocular
inflammation observed following administration of Abicipar pegol
2mg/0.05 mL results in an unfavorable benefit-risk ratio in the
treatment of neovascular (wet) age-related macular degeneration
(AMD). AbbVie plans to meet with the FDA to discuss their
comments and determine next steps.
"We continue to believe in the need for treatment options that
provide patients with reliable vision gains and less frequent
dosing for the treatment of nAMD," said Michael R. Robinson, M.D., Vice President,
Global Therapeutic Area Head, Ophthalmology, AbbVie. "We are
committed to working with the FDA to determine the appropriate next
steps for Abicipar pegol."
The global need for eye health services is projected to increase
dramatically in the coming decades, posing a considerable challenge
to healthcare systems. Through building a strong, active pipeline,
which is focused on significant unmet needs in eye care, AbbVie is
committed to developing and delivering sustainable solutions that
make a remarkable impact on people's lives.
About DARPin®
DARPin® molecules are derived from naturally occurring binding
proteins that consist of repeat sequences with capping structures
at each end of the protein. DARPin® molecules have three key
properties that have made them an important investigational class
of binding protein for researchers: high binding affinity, low
molecular weight and customizable applications. These three
properties make DARPin® molecules candidates for a broad range of
therapeutic applications and are currently being investigated in
therapeutic categories such as ophthalmology, oncology and
immuno-oncology. Allergan and Molecular Partners are committed to
advancing patient care through the development of molecules such as
Abicipar.
About Allergan Eye Care
As a leader in eye care, Allergan has discovered, developed, and
delivered some of the most innovative products in the industry for
more than 70 years. Allergan has launched over 125 eye care
products and invested billions of dollars in new treatments for the
most prevalent eye conditions including glaucoma, ocular surface
disease, and retinal diseases such as diabetic macular edema and
retinal vein occlusion. Our eye care pipeline includes over a dozen
additional agents for multiple ocular conditions.
We remain steadfast in helping eye care providers deliver the
best in patient care through innovative products and outreach
programs.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotech company
developing a new class of custom-built proteins known as DARPin®
therapeutics, designed to address challenges current modalities
cannot. The company has compounds in various stages of clinical and
preclinical development with a focus on oncology. Molecular
Partners has formed partnerships with leading pharmaceutical
companies to advance DARPin® therapeutics across multiple
therapeutic areas.
For more information regarding Molecular Partners AG, go
to: www.molecularpartners.com.
Disclaimer
This communication does not constitute an offer or invitation to
subscribe for or purchase any securities of Molecular Partners
AG. This publication may contain certain forward-looking statements
and assessments or intentions concerning the company and its
business. Such statements involve certain risks, uncertainties and
other factors which could cause the actual results, financial
condition, performance or achievements of the company to be
materially different from those expressed or implied by such
statements. Readers should therefore not place reliance on these
statements, particularly not in connection with any contract or
investment decision. The company disclaims any obligation to update
these forward-looking statements, assessments or intentions.
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SOURCE AbbVie