NDA Resubmission to the FDA Expected to Occur in the First
Quarter of 2020
LAVAL, Quebec and ALPHARETTA, Ga., Oct.
23, 2019 /CNW/ -- Bausch Health Companies Inc.
(NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb, its leading
global eye health business, and Clearside Biomedical, Inc. (Nasdaq:
CLSD) ("Clearside"), a biopharmaceutical company dedicated to
developing and delivering treatments that can restore and preserve
vision for people with serious back of the eye diseases, announced
today that an affiliate of Bausch Health has acquired an
exclusive license for the commercialization and development of
XIPERE™ (triamcinolone acetonide suprachoroidal injectable
suspension) in the United States
and Canada.
XIPERE is a proprietary suspension of the corticosteroid
triamcinolone acetonide formulated for suprachoroidal
administration via Clearside's proprietary SCS Microinjector™ that
is being investigated as a targeted treatment of macular edema
associated with uveitis. Clearside expects to resubmit its New Drug
Application (NDA) for XIPERE to the U.S. Food and Drug
Administration (FDA) for review in the first quarter of 2020 and
believes the FDA will review the NDA within six months of receipt
of the resubmission.
"Bausch Health is committed to continuing our pivot to offense
by augmenting our pipeline with investigational treatments like
XIPERE, which we believe will complement our Bausch + Lomb
portfolio of integrated eye health products," said Joseph C. Papa, chairman and CEO, Bausch Health. "If approved by the FDA, XIPERE
will be the first therapy available for patients suffering from
macular edema associated with uveitis."
"We believe that partnering with Bausch + Lomb will allow us to
maximize XIPERE's commercial potential and provide broad
accessibility for patients," said George Lasezkay, Pharm.D., J.D.,
CEO of Clearside. "With an established and experienced ophthalmic
sales force, we believe Bausch + Lomb can quickly and efficiently
integrate XIPERE into their commercial operations. We look forward
to coordinating with the Bausch + Lomb team to gain regulatory
approval and to share key learnings from our physician training
program to help ensure a successful launch of XIPERE in
the United States and Canada."
Under the terms of the agreement, Clearside will receive up to
$20 million in payments prior to
launch, including an upfront payment upon signing the agreement.
Clearside may receive additional payments based on certain
sales-based milestones and regulatory approvals for additional
indications of the XIPERE product. Clearside also will be entitled
to receive tiered royalties based on annual net sales of XIPERE in
the United States and Canada.
Bausch Health also has the right to pursue development and
commercialization of XIPERE for additional ophthalmic indications
in the United States and
Canada. Furthermore, Bausch Health
has the right to develop and commercialize Clearside's proprietary
SCS Microinjector in combination with certain specified
corticosteroids and NSAIDs in the United
States and Canada for the
field of ophthalmology.
About XIPERE™
XIPERE™ (triamcinolone acetonide
suprachoroidal injectable suspension), formerly known as CLS-TA, is
a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the back of the eye that
is being investigated for the treatment of macular edema associated
with uveitis. Clearside's patented technology is designed to
deliver drug to the suprachoroidal space located between the
choroid and the outer protective layer of the eye, known as the
sclera. Suprachoroidal injection enables the rapid and adequate
dispersion of medicine to the back of the eye, offering the
potential for the medicine to act longer and minimize harm to the
surrounding healthy parts of the eye.
About Clearside Biomedical
Clearside Biomedical, Inc.
is a biopharmaceutical company dedicated to developing and
delivering treatments that restore and preserve vision for people
with serious back of the eye diseases. Clearside's proprietary SCS
Microinjector™ targeting the suprachoroidal space (SCS) offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company's SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications, as well as future therapeutic innovations such as gene
therapy. For more information, please visit
www.clearsidebio.com.
About Bausch + Lomb
Bausch + Lomb, a Bausch Health
Companies Inc. company, is a leading global eye health organization
that is solely focused on helping people see. Its core businesses
include over-the-counter products, dietary supplements, eye care
products, ophthalmic pharmaceuticals, contact lenses, lens care
products, ophthalmic surgical devices and instruments. Bausch +
Lomb develops, manufactures and markets one of the most
comprehensive product portfolios in the industry, which is
available in approximately 100 countries. For more information,
visit www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Clearside Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as "believe", "expect", "may", "plan",
"potential", "will", and similar expressions, and are based on
Clearside's current beliefs and expectations. These forward-looking
statements include statements regarding the timing for resubmitting
the XIPERE NDA and the FDA's review of the resubmitted NDA,
maximizing XIPERE's commercial potential and providing broad
accessibility for patients and Bausch + Lomb's ability to
successfully launch XIPERE in the United
States and Canada. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Clearside's reliance on third parties over
which it may not always have full control, and other risks and
uncertainties that are described in Clearside's Annual Report on
Form 10-K for the year ended December 31,
2018, filed with the U.S. Securities and Exchange Commission
("SEC") on March 15, 2019,
Clearside's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2019, filed with the SEC on
August 8, 2019, and Clearside's other
Periodic Reports filed with the SEC. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Clearside as of the date of this release,
and Clearside assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Bausch Health's Cautionary Note
Regarding Forward-looking Statements
This news
release may contain forward-looking statements, which may generally
be identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. Where applicable, these
statements are based upon the current expectations and beliefs of
Bausch Health management and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. These risks
and uncertainties include, but are not limited to, risks and
uncertainties discussed in the Bausch Health's most recent annual
or quarterly report and detailed from time to time in the Bausch
Health's other filings with the SEC and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
In addition, certain material factors and assumptions have been
applied in making these forward-looking statements, including that
the risks and uncertainties outlined above will not cause actual
results or events to differ materially from those described in
these forward-looking statements. Bausch Health believes that the
material factors and assumptions reflected in these forward-looking
statements are reasonable, but readers are cautioned not to place
undue reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. Bausch
Health undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect actual outcomes, unless
required by law.
Investor
Contact:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-0617
|
(877) 281-6642 (toll
free)
|
|
|
|
Clearside
Biomedical Jenny Kobin
|
|
Remy
Bernarda
|
|
ir@clearsidebio.com
|
|
(678)
430-8206
|
|
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SOURCE Bausch Health Companies Inc.; Clearside Biomedical