DUBLIN, Sept. 9, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company with a
heritage of more than 70 years in eye care, and Molecular Partners
(SIX: MOLN), a clinical-stage biotechnology company developing a
new class of drugs known as DARPin® platform, today announced that
the U.S. Food and Drug Administration (FDA) has accepted a
Biologics License Application (BLA) and the European Medicines
Agency (EMA) has validated a Marketing Authorisation Application
(MAA) for Abicipar pegol, a novel, investigational
DARPin® therapy, in patients with neovascular (wet)
age-related macular degeneration (nAMD). The FDA is expected to
take action on the BLA mid-2020. A decision from the European
Commission is expected in the second half of 2020.
The BLA and MAA filings are based on data from two Phase 3
trials, CEDAR and SEQUOIA, which supported the non-inferior
efficacy of the Abicipar quarterly dosing regimen to maintain
vision gains with more than 50 percent fewer injections versus
ranibizumab (13 vs. 6) dosed monthly in the first year.
"Acceptance of our marketing applications brings us one step
closer to offering physicians and patients a new treatment option
that has the potential to reduce patient visits and injections
while achieving and maintaining vision gains with quarterly
dosing," said David Nicholson, Chief
Research and Development Officer, Allergan. "Today's announcement
reinforces Allergan's continued commitment to eye care innovation
and means patients are one step closer to receiving what we believe
to be a transformative treatment that will help address unmet needs
for nAMD patients."
The identical, global Phase 3 head-to-head pivotal trials, CEDAR
and SEQUOIA, assessed the efficacy and safety of Abicipar compared
with ranibizumab in treatment-naïve patients with nAMD. The primary
endpoint measured the proportion of treated patients with stable
vision at week 52 and, in both studies, Abicipar demonstrated
similar efficacy after 6 or 8 injections, compared to 13
ranibizumab injections in the first year of this study. The overall
adverse events were similar among the three treatment arms
(Abicipar dosed every 8 weeks, Abicipar dosed every 12 weeks, or
ranibizumab dosed monthly).
"The FDA filing acceptance marks an important milestone for the
DARPin® technology as Abicipar becomes our first DARPin® candidate
to receive filing acceptance by the FDA," commented Michael T. Stumpp, COO of Molecular Partners.
"We're excited for the potential Abicipar holds to become a true
quarterly dosed anti-VEGF treatment in patients with nAMD to
provide vision gains and improved quality of life."
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 13
additional agents for multiple ocular conditions.
Our commitment to the well-being of patients is also reflected
in philanthropy. Allergan and The Allergan Foundation support more
than 150 organizations around the world working to improve lives
and communities. We remain steadfast in helping eye care
providers deliver the best in patient care through innovative
products and outreach programs.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated with
divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
June 30, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotechnology
company that is developing a new class of therapies known as
DARPin® therapies. Molecular Partners has
compounds in various stages of clinical and preclinical development
and several more in the research stage, with a current focus on
ophthalmology and oncology. The company establishes research and
development partnerships with leading pharmaceutical companies and
is backed by established biotech investors. The company continues
to attract talented individuals who share the passion to develop
breakthrough medicines for serious diseases.
For more information regarding Molecular Partners AG, go
to: www.molecularpartners.com.
Contacts Molecular
Partners AG
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Patrick Amstutz,
CEO
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Lisa Raffensperger,
International Media
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patrick.amstutz@molecularpartners.com
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lisa@tenbridgecommunications.com
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Tel: +41 44 755 77
00
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Tel: +1 617 903
8783
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Thomas
Schneckenburger, IR & Media
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Susan A. Noonan, IR
USA
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thomas.schneckenburger@molecularpartners.com
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susan@sanoonan.com
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Tel: +41 44 755
5728
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Tel.: +1 212 966
3650
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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.
CONTACTS: Allergan:
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Investors:
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Manisha Narasimhan,
PhD
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(862)
261-7162
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Media:
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Lisa Brown
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(862)
261-7320
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Lisa Kim
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(714)
246-3843
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SOURCE Allergan plc