Ocular Therapeutix™ Announces Kevin Hanley as Senior Vice President, Technical Operations & Naymisha Patel as Vice Presiden...
January 08 2018 - 8:00AM
Business Wire
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
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/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke PartnersChris Brinzey,
339-970-2843chris.brinzey@westwicke.comorMediaOcular
TherapeutixScott CorningVice President of Marketing &
Commercial Operationsscorning@ocutx.com
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Apr 2023 to Apr 2024