Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe
November 14 2023 - 8:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to achieve FDA approval for the first ophthalmic
formulation of bevacizumab for the treatment of retinal diseases,
today announced the appointment of Jedd Comiskey as Senior VP –
Head of Europe.
Mr. Comiskey has a successful track record in
the planning, organization and execution of product launches. Over
the course of his career, he has demonstrated innovative,
solution-focused results, navigating the highly complex European
pharmaceutical landscape.
“We believe in the potential of ONS-5010 to
address the global need for an approved bevacizumab that meets
ophthalmic standards for the treatment of wet AMD. While continuing
our efforts to meet the additional requirements that the FDA is
requiring for U.S. approval of ONS-5010, we are working toward the
upcoming decision date for our Marketing Authorization Application
(MAA) in Europe with the EMA, expected in the first half of 2024.
We believe Jedd will play an integral role as we prepare for a
potential European partnership in launching ONS-5010,” commented
Russell Trenary, President and CEO of Outlook Therapeutics.
Mr. Comiskey added, “I am thrilled to join the
Outlook Therapeutics team to help solidify the Company’s global
launch strategy, and I believe ONS-5010 has the potential to be a
meaningful treatment option in the ophthalmology landscape in
Europe. As the Company continues its work towards potential
European launch, I look forward to leveraging the valuable
experience and proven approaches I’ve executed over my career to
enable us to hit the ground running.”
Prior to joining Outlook Therapeutics, Jedd
served as the Senior Brand Director; Ophthalmology at Apellis
Switzerland GmbH. As part of his role, Jedd was the commercial lead
for the launch of SYFOVRE® (pegcetacoplan), defining regional brand
strategy, formulating key market commercialization plans, engaging
stakeholders, and supporting affiliates with launch preparations.
In addition to his regional role, Jedd was accountable for detailed
mapping of the ophthalmology landscape, preparatory stakeholder
engagement and formulation of comprehensive commercialization
strategy, and infrastructure plans at Apellis. Prior to that, Jedd
served as the Franchise Head GI Rare at Takeda Pharmaceuticals
International AG where he was responsible for directing the
company’s commercial launch across Europe and Canada for two
treatments indicated for rare gastrointestinal disorders. He also
served as the Director of Market Access and Marketing at Takeda
Products Ireland Ltd. Additional career appointments include Head
of Market Access at Bayer Ltd, Market Access Manager at Takeda
Products Ireland Ltd, Product Manager: ADHD at Shire
Pharmaceuticals Ireland Ltd, and Cardiovascular Product Manager at
Servier Laboratories Ireland Ltd.
Mr. Comiskey holds a Bachelor of Science in
Chemistry from the University College Dublin and a PhD in Chemistry
from the Royal College of Surgeons in Ireland.
About Outlook Therapeutics,
Inc.
Outlook Therapeutics is a biopharmaceutical
company working to achieve FDA approval for the launch of ONS-5010/
LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic
formulation of bevacizumab for use in retinal indications,
including wet AMD, DME and BRVO. The FDA accepted Outlook
Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with an
initial PDUFA goal date of August 29, 2023; the FDA did not approve
the BLA during this review cycle and the Company is working with
the FDA to address the issues that have been raised so that the BLA
may be re-submitted. If ONS-5010 ophthalmic bevacizumab is
approved, Outlook Therapeutics expects to commercialize it as the
first and only FDA-approved ophthalmic formulation of bevacizumab
for use in treating retinal diseases in the United States, United
Kingdom, Europe, Japan, and other markets. As part of the Company’s
multi-year commercial planning process, Outlook Therapeutics and
Cencora, formerly AmerisourceBergen, entered into a strategic
commercialization agreement to expand the Company’s reach for
connecting to retina specialists and their patients. Cencora will
provide third-party logistics (3PL) services and distribution, as
well as pharmacovigilance services and other services in the United
States. For more information, please visit
www.outlooktherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical
facts are “forward-looking statements,” including those relating to
future events. In some cases, you can identify forward-looking
statements by terminology such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “may,” “might,”
“intend,” “potential,” “predict,” “should,” or “will,” the negative
of terms like these or other comparable terminology, and other
words or terms of similar meaning. These include, among others,
statements about ONS-5010’s potential as the first FDA-approved
ophthalmic formulation of bevacizumab-vikg, expectations concerning
our ability to remediate or otherwise resolve deficiencies
identified in the Complete Response Letter issued by the FDA,
expectations concerning decisions of regulatory bodies, including
the FDA and the EMA, and the timing thereof, plans for potential
commercial launch of ONS-5010, expectations concerning our
relationship with AmerisourceBergen and the benefits and potential
expansion thereof and other statements that are not historical
fact. Although Outlook Therapeutics believes that it has a
reasonable basis for the forward-looking statements contained
herein, they are based on current expectations about future events
affecting Outlook Therapeutics and are subject to risks,
uncertainties and factors relating to its operations and business
environment, all of which are difficult to predict and many of
which are beyond its control. These risk factors include those
risks associated with developing pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, the content and timing of decisions
by the FDA, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission
(the “SEC”), including the Annual Report on Form 10-K for the
fiscal year ended September 30, 2022 as supplemented by the
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023,
in each case as filed with the SEC and future quarterly reports we
file with the SEC, which include the uncertainty of future impacts
related to macroeconomic factors, including as a result of the
ongoing overseas conflict, high interest rates, inflation and
potential future bank failures on the global business environment.
These risks may cause actual results to differ materially from
those expressed or implied by forward-looking statements in this
press release. All forward-looking statements included in this
press release are expressly qualified in their entirety by the
foregoing cautionary statements. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. Outlook Therapeutics does not undertake
any obligation to update, amend or clarify these forward-looking
statements whether as a result of new information, future events or
otherwise, except as may be required under applicable securities
law.
CONTACTS:
Media Inquiries:Harriet UllmanVice
PresidentLaVoieHealthScienceT:
617.429.5475hullman@lavoiehealthscience.com
Investor Inquiries: Jenene Thomas Chief
Executive Officer JTC Team, LLC T: 833.475.8247 OTLK@jtcir.com
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