DUBLIN, Oct. 11, 2019 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company with a more
than 70-year heritage in ophthalmology and Molecular Partners (SIX:
MOLN), a clinical-stage biopharmaceutical company developing a new
class of drugs known as DARPin® therapies, today announced two-year
data from the CEDAR and SEQUOIA clinical studies of investigational
Abicipar in patients with neovascular (wet) age-related macular
degeneration (nAMD). In the second year of these studies, four
injections of Abicipar resulted in the maintenance of visual gains
comparable to monthly ranibizumab. These data were presented as a
late-breaking oral presentation during Retina Subspecialty Day at
the Annual Meeting of the American Academy of Ophthalmology
(AAO).
CEDAR and SEQUOIA are identical global Phase 3 studies designed
to assess the efficacy and safety of Abicipar 8-week and 12-week
treatment regimens compared with monthly ranibizumab in
treatment-naïve patients with nAMD. Allergan previously announced
that Abicipar met the prespecified primary end point of the
proportion of patients with stable vision at week 52 demonstrating
non-inferiority in both the 8-week and 12-week treatment regimens
compared to monthly ranibizumab.
Through week 104, patients received Abicipar 2 mg every 8-weeks
or every 12-weeks or ranibizumab 0.5 mg every 4 weeks. At week 104
in the pooled Phase 3 data, the proportion of patients with stable
vision was 93%, 90% and 94% in 8-week Abicipar; 12-week Abicipar
and 4-week ranibizumab treatment regimens, respectively. This
continuation of stable vision in year 2 further reinforces the
ability of Abicipar to deliver consistent quarterly dosing for the
majority of patients.
"Current anti-VEGF treatments for neovascular age-related
macular degeneration require frequent intravitreal injections,"
said Rahul N. Khurana, M.D.,
Northern California Retina Vitreous Associates Medical Group.
"Based on the results of CEDAR and SEQUOIA, which reinforce the
efficacy of Abicipar while decreasing the number of injections,
Abicipar could transform anti-VEGF treatment regimens."
Mean changes in best-corrected visual acuity (BCVA) seen in year
two were similar when compared to year one across all treatment
arms. Central retinal thickness (CRT) continued to decrease during
year two when compared to year one. CRT for patients treated with
Abicipar dosed quarterly and every 8-weeks were similar to
ranibizumab dosed every 4 weeks through week 104. Overall incidence
rates of treatment-emergent adverse events at the end of year two
were comparable between treatment groups. The pooled rate of new
cases of intraocular inflammation in year two for patients who
received Abicipar in the 8-and 12-week arms was 1.9%, which is
similar to the ranibizumab arm of 1%.
"These late-breaking data further demonstrate the potential of
Abicipar to provide consistent quarterly dosing that sustains
vision gains in the majority of patients with neovascular
age-related macular degeneration," said David Nicholson, Chief Research and Development
Officer, Allergan. "On the heels of regulatory filings for Abicipar
in the United States and European
Union, these data give us confidence in our ability to meet a
serious unmet need for patients and eye doctors."
"We are very excited at the continued success of Abicipar, our
most advanced DARPin® molecule, in the treatment of patients with
neovascular age-related macular degeneration," Patrick Amstutz, PhD, CEO of Molecular Partners.
"We are pleased to see a sustained response at two-years with less
frequent dosing of Abicipar compared to standard of care
therapy."
The U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) are currently reviewing regulatory
applications for Abicipar in patients with nAMD. The FDA is
expected to take action on the BLA in mid-2020. A decision from the
European Commission is expected in the second half of 2020.
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.
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.
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.
CONTACTS: Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7162
Media:
Lisa Brown
(862) 261-7320
Lisa Kim
(714) 246-3843
View original content to download
multimedia:http://www.prnewswire.com/news-releases/allergan-and-molecular-partners-present-late-breaking-data-from-phase-3-studies-of-investigational-abicipar-pegol-in-neovascular-wet-age-related-macular-degeneration-300937326.html
SOURCE Allergan plc