Sustained Release Formulation Has Potential to
Significantly Advance Current Standard of Care by Reducing
Injection Frequency in the Treatment of Wet AMD
Ocular Therapeutix Eligible to Receive up to
$305 Million in Milestone Payments in Addition to Royalties on
Potential Future Net Sales
Company to Host Conference Call Today at 8:30
am Eastern Time
Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced that it has entered into a strategic collaboration,
option and license agreement with Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN). Ocular and Regeneron will collaborate on the
development of a sustained release formulation of the vascular
endothelial growth factor (VEGF) trap aflibercept for the treatment
of wet age-related macular degeneration (wet AMD) and other serious
retinal diseases. This formulation is currently in preclinical
development. Regeneron’s aflibercept is currently approved by the
U.S. Food and Drug Administration for certain indications under the
brand name EYLEA®.
Ocular Therapeutix is currently developing proprietary
sustained-release hydrogel-based drug delivery depots for
intravitreal injection that can be formulated with both small and
large molecule pharmaceuticals, such as tyrosine kinase inhibitors
(TKIs) and protein-based anti-VEGFs, respectively, with the goal of
delivering sustained and therapeutic levels of drugs to targeted
ocular tissues.
Under the terms of the agreement, Ocular Therapeutix and
Regeneron will aim to develop a sustained release formulation of
aflibercept that is suitable for advancement into clinical
development. Regeneron has the option to obtain an exclusive
license to use Ocular Therapeutix’s hydrogel-based technology for
the development and commercialization of a sustained release
formulation of aflibercept and other biologics targeting VEGF for
ophthalmic indications. Ocular Therapeutix will retain all rights
to develop its sustained-release hydrogel-based drug delivery
platform with all other non-VEGF targeting compounds as well as
with small molecule pharmaceuticals, including TKIs, for other
retinal diseases.
Upon exercising of the option, Ocular Therapeutix would receive
a payment of $10 million from Regeneron and Ocular Therapeutix
would be responsible for funding development through Phase 1.
Regeneron would be responsible for any subsequent development and
commercialization costs. Ocular Therapeutix would be eligible to
receive up to $305 million in milestone payments from Regeneron for
a sustained release version of aflibercept containing Ocular
Therapeutix’s sustained release hydrogel depot, comprised of up to
$155 million in development and regulatory milestone payments, $100
million for the first commercial sale and up to $50 million in
commercial milestone payments. In addition, Ocular Therapeutix is
eligible to receive tiered high single-digit to low-to-mid
teen-digit royalties on potential future net sales.
“We have made considerable progress in developing our protein
drug delivery platform at Ocular Therapeutix, so it is good to see
an industry leader such as Regeneron recognizing the potential of
this technology,” said Amar Sawhney, Ph.D., President, Chief
Executive Officer and Chairman of Ocular Therapeutix. “We are
excited to partner with Regeneron to develop a potential
first-in-class sustained release protein-based anti-VEGF hydrogel
injection for wet AMD, DME, RVO, and other serious retinal
diseases. This sustained release formulation could have the
potential to significantly reduce dosing frequency and subsequently
reduce doctor visits, thus reducing the burden of care for
patients, caregivers and physicians, and may decrease the
likelihood of certain side effects associated with frequent
intravitreal injections.”
About Wet AMD and Other VEGF-Associated Retinal
Diseases
Wet age-related macular degeneration (wet AMD) is characterized
by loss of vision caused by degeneration of the central portion of
the retina. Abnormal growth of blood vessels below the retina, and
the leakage of fluid and protein from the vessels, causes retinal
degeneration and can lead to severe and rapid loss of vision. Wet
AMD is the leading cause of blindness in individuals aged 50 years
or older.
Retinal vein occlusion (RVO) is a sight-threatening disorder
resulting from the blockage of one of the veins carrying blood out
of the retina. In RVO, the blockage of a retinal vein can lead to
poor blood circulation, low oxygen and sometimes inflammation in
the eye. A blocked vein will leak its contents of blood and fluid.
Bleeding within the retina and swelling from the fluid can result
in macular edema.
Diabetic macular edema (DME) is a complication of diabetes
caused by fluid accumulation in the macula, or central portion of
the eye. When the macula begins to fill with fluid, the ability of
those cells to sense light is impaired, causing blurred vision that
can be severe. Diabetic macular edema affects up to 30% of people
who have had diabetes for 20 years or more, and if untreated, 20 to
30% of people who have it will experience moderate visual loss.
The global market for anti-VEGF drugs is over $7.5 billion.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a
live conference call and webcast today at 8:30 am Eastern Time to
discuss the collaboration with Regeneron as well as other recent
progress from the Company's intravitreal depot development
programs.
The live webcast and accompanying slide presentation can be
accessed by visiting the investor section of the Company’s website
at investors.ocutx.com. Please connect at least 15 minutes prior to
the live webcast to ensure adequate time for any software download
that may be needed to access the webcast. Alternatively, please
call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen
to the conference call. The conference ID number for the live call
will be 98223266. An archive of the webcast will be available until
October 27, 2016 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary hydrogel platform technology. Ocular Therapeutix
has submitted an NDA for post-surgical pain for its lead product
candidate, DEXTENZA™ (dexamethasone insert, extended release),
which is in Phase 3 clinical development for post-surgical ocular
inflammation and pain and allergic conjunctivitis, and in Phase 2
clinical development for dry eye disease. OTX-TP (sustained release
travoprost) is in Phase 3 clinical development for glaucoma and
ocular hypertension. Ocular Therapeutix is also evaluating
sustained-release injectable drug depots for back-of-the-eye
diseases. Ocular Therapeutix's first product, ReSure® Sealant, is
FDA-approved to seal corneal incisions following cataract surgery.
For additional information about the Company, please visit
www.ocutx.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
potential benefits and future operation of the collaboration with
Regeneron, including any potential future payments thereunder, the
ongoing development of the Company’s sustained release hydrogel
depot technology, the development and regulatory status of the
Company’s other product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for
post-surgical ocular inflammation and pain, including our
expectations regarding the NDA filed with the FDA, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for dry eye disease
and OTX-TP for the treatment of glaucoma and ocular hypertension,
the potential utility of any of the Company’s product candidates,
potential commercialization of the Company’s product candidates,
the sufficiency of the Company’s cash resources and other
statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend", "goal," "may", "might," "plan,"
"predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors. Such forward-looking
statements involve substantial risks and uncertainties that could
cause the Company’s clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, those related to the
timing and costs involved in commercializing ReSure® Sealant or any
product candidate that receives regulatory approval, the initiation
and conduct of clinical trials, availability of data from clinical
trials and expectations for regulatory submissions and approvals,
the Company’s scientific approach and general development progress,
the availability or commercial potential of the Company’s product
candidates, the sufficiency of cash resources and need for
additional financing or other actions and other factors discussed
in the “Risk Factors” section contained in the Company’s quarterly
and annual reports on file with the Securities and Exchange
Commission. In addition, the forward-looking statements included in
this press release represent the Company’s views as of the date of
this release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date of this release.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161013005405/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaOcular Therapeutix,
Inc.Scott CorningVice President of Sales and
Marketingscorning@ocutx.com
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