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
BEDFORD, Mass--(BUSINESS WIRE)--Oct. 13, 2016--
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
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
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.
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/
Source: Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Vice President of Sales and