Experienced additions complete the recent transformation of the
management team
Attention turns to seeking approval of DEXTENZA™ and building a
leading development-focused biopharmaceutical company
BEDFORD, Mass.--(BUSINESS WIRE)--Jan. 8, 2018--
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company
focused on the development, manufacturing and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced the appointment of Kevin Hanley as Senior Vice President,
Technical Operations and Naymisha Patel as Vice President of Quality.
“We are thrilled to welcome both Kevin and Naymisha to Ocular
Therapeutix,” said Antony Mattessich, President and Chief Executive
Officer. “Since receiving the Complete Response Letter from FDA for
DEXTENZA™ last July, we have significantly transitioned our senior
management team, bringing in over 100 years of combined pharmaceutical
and biologic leadership experience to maximize the opportunity around
our technology platform. Kevin’s appointment completes the senior
management transition and is key to our focus on ensuring that our core
DEXTENZA™ manufacturing capabilities meet cGMP standards and can supply
anticipated commercial needs.”
Kevin Hanley brings over 30 years of experience managing biotechnology
and pharmaceutical operations with demonstrated success in technology
transfer and process scale-up for the manufacturing of proteins from
development through commercialization. In addition, Hanley has authored
and reviewed numerous CMC manufacturing sections for regulatory
submissions. He is associated with the development and clinical
progression of an extensive number of novel clinical proteins and the
successful commercialization of seven protein biopharmaceuticals. Prior
to joining Ocular Therapeutix, Hanley served in leadership roles with
Pfizer and Wyeth BioPharma as Senior Director, Network Process
Technology Innovation and Senior Director, Manufacturing. His work
included a focus on increasing operational effectiveness in
manufacturing quality and cGMP standards through the implementation of
six sigma methodologies and on contributing to Pfizer’s biotechnology
emerging market manufacturing strategy. Hanley holds a B.S. in Biology
from Framingham State College and M.S. in Chemical Engineering from
Tufts University.
In addition, Ocular Therapeutix announced the appointment of Naymisha
Patel as Vice President of Quality. “Naymisha’s experience leading teams
as well as building quality systems and overseeing regulatory compliance
will be extremely valuable as we prepare for the resubmission of the
DEXTENZA™ NDA,” said Daniel Bollag, Ph.D., Senior Vice President,
Regulatory Affairs & Quality. Patel brings over 20 years of experience
with a proven track record in quality management, process improvement,
regulatory submissions and regulatory compliance. Most recently, Patel
served as the Head of Global Quality at Prothena Corporation plc, before
which she served as Vice President, Regulatory and Quality of StemCells,
Inc. She also held roles in Quality at Geron Corporation and Nektar
Therapeutics. Patel holds a B.A. in Chemistry from California State
University, B.S. in Chemistry from the Maharaja Sayajirao University,
and M.B.A. from Northcentral University in Scottsdale, Arizona.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development, manufacturing and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary
hydrogel-based formulation technology. Ocular Therapeutix’s lead product
candidate, DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular
use, has completed Phase 3 clinical development for the treatment of
ocular pain and inflammation following ophthalmic surgery. OTX-TP
(travoprost insert) is in Phase 3 clinical development for the reduction
of intraocular pressure in patients with glaucoma and ocular
hypertension. The Company’s earlier stage assets include OTX-TIC, a
sustained release travoprost intracameral injection for the reduction in
intraocular pressure in patients with glaucoma and ocular hypertension,
as well as sustained release intravitreal injections for the treatment
of retinal diseases. These injections include the development of
OTX-TKI, a tyrosine kinase inhibitor (TKI), and, in collaboration with
Regeneron, an extended release protein-based anti-vascular endothelial
growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure®
Sealant, is FDA-approved to seal corneal incisions following cataract
surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding product development efforts and
regulatory submissions for and the timing and conduct of clinical trials
of DEXTENZA™ for the treatment of post-surgical ocular inflammation and
pain, including with respect to the manufacturing deficiencies
identified by the FDA and the prospects for approvability of DEXTENZA™
for these indications, DEXTENZA™ for the treatment of allergic
conjunctivitis, DEXTENZA™ for the treatment of dry eye disease and
OTX-TP for the treatment of glaucoma and ocular hypertension, the
ongoing development of the Company’s sustained release intravitreal
depot, 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, 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
manufacturing operations, the Company’s scientific approach and general
development progress, the availability or commercial potential of the
Company’s product candidates, the availability 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/20180108005641/en/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke
Partners
Chris Brinzey, 339-970-2843
chris.brinzey@westwicke.com
or
Media
Ocular
Therapeutix
Scott Corning
Vice President of Marketing &
Commercial Operations
scorning@ocutx.com