- Alliance will provide opportunity for AbbVie to further
expand its diverse eye care portfolio and provide additional
treatment options for glaucoma
patients
- Collaboration further
supports the role of MINIject® in the treatment of glaucoma
and accelerates goal to bring MINIject to more patients
globally
- Deal terms include a $60M upfront payment to iSTAR Medical
-
iSTAR Medical to continue development and commercialization of the
MINIject device up to completion of the U.S. PMA study
NORTH CHICAGO,
Ill. and WAVRE, Belgium, July 20,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and
iSTAR Medical SA, today announced a strategic transaction to
further develop and commercialize iSTAR Medical's
MINIject® device, a minimally invasive glaucoma surgical
(MIGS) device for patients with glaucoma. This complementary
alliance will support iSTAR Medical's development and commercial
efforts for MINIject®, as well as provide an opportunity
to expand AbbVie's eye care business, building on its glaucoma
portfolio which includes drops, sustained release implants, and
stent offerings.
MINIject® received Conformité Européenne (CE) marking
approval to commercialize in European countries in the last quarter
of 2021 and launched commercially in select European countries in
early 2022. iSTAR Medical is currently enrolling a U.S. Premarket
Approval study (STAR-V) to enable commercialization in the U.S.
"As a leading company in eye care with a commitment to a broad
and diverse portfolio from the front to the back of the eye, along
with our global footprint and infrastructure in glaucoma, we are
well-positioned to support bringing this MIGS offering to patients
and glaucoma specialists through this strategic alliance," said
Michael Robinson, M.D, Vice
President, Global Therapeutic Area Head of Eye Care, AbbVie. "This
alliance with iSTAR Medical is an important step as we continue to
be an innovator in glaucoma by maximizing the value of
interventional approaches throughout the treatment paradigm."
"Today's announcement is validation of the transformational role
of MINIject in the treatment of glaucoma," said Michel Vanbrabant, Chief Executive Officer,
iSTAR Medical. "Our commitment has always been to enable more
glaucoma patients globally to be treated effectively in a
minimally-invasive manner with our MINIject® MIGS
device, and this alliance accelerates that goal, especially in
the United States. We will benefit
from AbbVie's strong global experience and knowledge base already
established in glaucoma, and we are excited to be working with such
a world class team."
Under the terms of the agreement, iSTAR Medical will receive a
$60M non-dilutive upfront payment and
will continue to develop and commercialize MINIject®
until completion of the STAR-V clinical study. AbbVie will hold the
exclusive right to acquire iSTAR Medical and lead subsequent global
development and commercialization of the MINIject device. If AbbVie
exercises the right to acquire iSTAR, the stockholders of iSTAR
Medical would also be eligible to receive additional contingent
payments of up to $475M in a closing
payment and upon achievement of certain predetermined
milestones.
iSTAR Medical will remain an independent company through the
completion of the STAR-V study. This financing will support the
continued development and commercialization of
MINIject®, including ongoing clinical studies and
further enhancements to the technology. SVB Securities LLC acted as
financial advisor to iSTAR Medical.
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 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
About iSTAR Medical
iSTAR Medical is committed to
delivering breakthrough eye care solutions. Our most advanced
product, MINIject®, is approved in Europe for the treatment of open-angle
glaucoma – the leading cause of irreversible blindness – and we are
aiming to seek market approval in the US. We believe
MINIject®'s distinctive tissue-integrating capabilities
unlock a safer, and more effective option for patients. We are
building an exceptional team and pipeline of innovative products
such as MINIject® to establish new treatment
paradigms in eye care conditions with the highest patient needs.
For more information, please visit: www.istar-medical.com
About
MINIject®
MINIject® is iSTAR
Medical's innovative MIGS device for patients with primary
open-angle glaucoma. MINIject® combines the distinctive
porous structure of its proprietary STAR® material with
the power offered by the supraciliary space. As a result, it is
designed to enhance natural fluid outflow, reducing intraocular
pressure (IOP) and the need for medication, while bio-integrating
with surrounding tissue, limiting inflammation, fibrosis and
subsequent complications.
About Glaucoma
Glaucoma is a progressive disease
affecting over 100 million people globally, of which primary
open-angle glaucoma is the most common
form.1,2 IOP reduction, through
medication or surgery, helps delay disease progression.3
Medication is generally the first line treatment, but the
progressive addition of multiple drops can burden patients with
side effects, compliance challenges and costs.1,3 More
invasive surgical options can present risks with irreversible
complications and often requires long-term patient
management.1,3 MIGS is one of the most promising and
fastest-growing glaucoma therapies due to the potential for an
enhanced safety profile.1
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 2021 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.
1 Market
Scope, "2021 Glaucoma Surgical Device Market Report", July 2021.
https://www.market-scope.com/pages/reports/267/2021-glaucoma-surgical-device-market-report
|
2 Jonas JB,
Aung T, Bourne RR et al. "Glaucoma". Lancet 2017; 390:
2083–93
|
3 "European
Glaucoma Society Terminology and Guidelines for Glaucoma", 4th
Edition: British Journal of Ophthalmology. 2017;101:1-195
https://bjo.bmj.com/content/101/5/73
|
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SOURCE AbbVie