DUBLIN, July 19, 2018 /PRNewswire/
-- Allergan plc, (NYSE: AGN), a leading global
pharmaceutical company and Molecular Partners (SIX: MOLN), a
clinical-stage biopharmaceutical company developing a new class of
drugs known as DARPin® therapies, today announced the release of
two positive clinical trials, SEQUOIA and CEDAR for abicipar,
demonstrating that both the 8-week and 12-week treatment regimens
met the pre-specified primary endpoint of non-inferiority to
ranibizumab. SEQUOIA and CEDAR are identical global phase 3 studies
designed to assess the efficacy and safety of abicipar compared
with ranibizumab in treatment-naïve patients with neovascular
age-related macular degeneration (AMD). The primary endpoint
measured the proportion of treated patients with stable vision at
week 52.
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. The incidence of intraocular inflammation
was higher in the abicipar arms compared to ranibizumab-treated
patients in both trials. We are further analyzing these results.
SEQUOIA and CEDAR clinical trials continue on a masked basis for a
second year.
The filing for abicipar is planned for the first half of 2019.
Allergan will be requesting a meeting with the Food and Drug
Adminstration (FDA) to discuss our BLA submission.
In the SEQUOIA study, the proportion of patients with stable
vision in abicipar dosed Q8 was 94.8 percent, in Q12 was 91.3
percent compared to ranibizumab dosed Q4 96.0 percent.
In CEDAR, the proportion of patients with stable vision in the
abicipar dosed Q8 was 91.7 percent, in Q12 was 91.2 percent
compared to ranibizumbab dosed Q4 95.5 percent.
"In both studies abicipar demonstrated remarkable efficacy in
the 8-week and 12-week regimens," said David Nicholson, Chief Research and Development
Officer, Allergan. "We are pleased with the outcome of these
trials. We believe the SEQUOIA and CEDAR studies demonstrated what
we set out to achieve, strong efficacy and duration of effect which
shows the potential of abicipar as a treatment for AMD patients. We
have generated important findings in these trials to address a
serious unmet need. We will continue to review these data including
inflammation findings and are working on further optimizing the
abicipar formulation."
"Abicipar could transform the way physicians manage AMD with
anti-VEGF therapy. Today's anti-VEGFs were designed for
monthly or bimonthly dosing. In the real world, patients have
difficulty adhering to the schedule, which places their vision at
risk. The adopted treat-and extend approach, while
practical, is supported by limited data and in certain cases shows
sub-optimal visual outcomes. Treat-and-extend amounts to a
compromise for most patients who are unable or unwilling to
comply with frequent injections. Abicipar could be the first
and only 12- week anti-VEGF treatment that improves visual outcomes
in a real world setting for a large number of AMD patients," said
Raj Maturi, MD, Midwest Eye Institute & Associate Professor
Ophthalmology, Indiana University School of
Medicine.
"We are very excited to see that the most advanced
DARPin® molecule, abicipar, reaches its primary endpoint
in phase 3. This is a very important milestone for Molecular
Partners and the DARPin® technology in general," said
Patrick Amstutz, PhD, CEO of
Molecular Partners. "We are very pleased to see that abicipar can
indeed help patients in need with less frequent dosing which was
the key point when we generated abicipar in the first place," added
Michael T. Stumpp, PhD, COO of
Molecular Partners.
In the SEQUOIA study, overall treatment-emergent adverse events
were similar among the 3 treatment arms, reported in 78.3 percent,
78.0 percent and 74.0 percent of patients receiving abicipar Q8,
abicipar Q12 and ranibizumab Q4, respectively.
Incidence of intraocular inflammation events was similar among
the two abicipar treatment groups but higher than the ranibizumab
arm and reported at 15.7 percent and 15.3 percent of patients in
the abicipar Q8 and Q12 arms compared to 0.6 percent in the
ranibizumab Q4 arm.
In the CEDAR study, overall treatment-emergent adverse events
were similar among the 3 treatment arms reported in 73.7
percent, 81.1 percent and 73.2 percent of patients receiving
abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively.
Incidence of intraocular inflammation events was similar among
the two abicipar treatment groups but higher than ranibizumab arm
and reported at 15.1 percent and 15.4 percent of patients in the
abicipar Q8 and Q12 arms compared to 0 percent in the ranibizumab
Q4.
Allergan is continuing to review these data. The full data
details of the primary endpoints and the secondary endpoints
will be presented at an upcoming scientific conference.
About the Abicipar SEQUOIA (006) AND CEDAR (005) Study
Design
These multicentered, randomized studies were conducted as global
Phase 3 studies designed to assess the efficacy and safety of
abicipar pegol compared with ranibizumab in treatment-naïve
patients with neovascular age-related macular degeneration (AMD).
The primary endpoint was based on a proportion of patients
with stable vision at Week 52. Stable vision is defined as the
proportion of patients with vision loss of fewer than or equal to
15 letters in best-corrected visual acuity (BCVA) from baseline.
The study included 3 treatment arms: one arm was Q8: 2 mg abicipar
pegol. 3 monthly doses followed by a dose every 8 weeks. 8
doses total for the primary analysis.
The second arm was Q12: 2 mg abicipar pegol with 2 monthly
doses, followed by a dose after 8 weeks, followed by every 12 weeks
dosing with 6 doses total for the primary analysis. The third arm
was RQ4: 0.5 mg ranibizumab monthly doses and 13 doses total for
the primary analysis.
ALLERGAN CONFERENCE CALL AND WEBCAST
Allergan will host a conference call and webcast today,
Thursday, July 19, at 8:30 a.m. Eastern Time to discuss the results of
the Abicipar study. The dial-in number to access the call is
U.S./Canada (877) 251-7980, International (706) 643-1573, and
the conference ID is 2267319.
A taped replay of the conference call will also be available
beginning approximately two hours after the call's conclusion, and
will remain available through 11:30 p.m. Eastern
Time on August 19, 2018. The replay may be accessed by
dialing (855) 859-2056 or (404) 537-3406, and entering the
conference ID 2267319.
To access the webcast, please visit Allergan's Investor
Relations website at
https://www.allergan.com/investors/events-presentations. A replay
of the webcast will also be available on Allergan's Investor
Relations website.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical leader. Allergan is 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 for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues'
commitment to being Bold for Life. Together, we build bridges,
power ideas, act fast and drive results for our customers and
patients around the world by always doing what is right.
With commercial operations 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;
uncertainty associated with financial projections, projected cost
reductions, 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,
2017 and Allergan's Quarterly Report on Form 10-Q for the
period ended March 31, 2018. 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 biopharmaceutical
company that is developing a new class of therapies known as
DARPin® therapies. With a management team that includes many of the
founding scientists, the company continues to attract talented
individuals who share the passion to develop breakthrough medicines
for serious diseases. 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.
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 Molecular Partners AG and its
business. Such statements involve certain risks, uncertainties and
other factors which could cause the actual results, financial
condition, performance or achievements of Molecular Partners AG 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. Molecular Partners AG disclaims any obligation
to update these forward-looking statements, assessments or
intentions. Further, neither Molecular Partners AG nor any of its
directors, officers, employees, agents, counsel or advisers nor any
other person makes any representation or warranty, express or
implied, as to, and accordingly no reliance should be placed on,
the accuracy or completeness of the information contained herein or
of the views given or implied.
CONTACTS:
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Allergan:
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Investors:
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Daphne
Karydas
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(862)
261-8006
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Karina
Calzadilla
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(862)
261-7328
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Media:
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Amy Rose
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(862)
289-3072
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Fran
DeSena
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(862)
261-8820
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SOURCE Allergan plc