Outlook Therapeutics® Announces Strategic Organizational Realignment
December 06 2023 - 8:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a
biopharmaceutical company working to achieve U.S. Food and Drug
Administration (FDA) approval for the first ophthalmic formulation
of bevacizumab for the treatment of retinal diseases, today
announced a realignment of resources.
Effective immediately, Joel Prieve, formerly the
Senior Vice President of Commercial Operations, has been appointed
to the role of Senior Vice President of Licensing and M&A. In
this role, he will be responsible for developing and executing the
Company's strategy in the areas of licensing and partnerships, as
well as evaluating and executing potential merger and acquisition
opportunities. Additionally, Terry Dagnon, formerly Chief
Operations Officer, will assume the new role of Senior Advisor.
Previously, Outlook Therapeutics announced the addition of Jedd
Comiskey as Senior Vice President – Head of Europe to focus on
potential commercial launch and commercial partnership
opportunities for ONS-5010 in the EU, if approved.
As previously reported, Outlook Therapeutics is
working with the FDA to design an additional adequate and
well-controlled clinical trial to support the planned ONS-5010 BLA
resubmission. Based on the October Type A meeting and ongoing
informal discussions with FDA, Outlook Therapeutics has submitted a
protocol for a non-inferiority study evaluating ONS-5010 versus
ranibizumab in a 3-month study of treatment naïve patients with a
primary efficacy endpoint at 2 months. Upon confirmation of the
protocol details with the FDA, Outlook Therapeutics intends to
submit a Special Protocol Assessment (SPA) to memorialize the
agreement with the FDA on the trial design and confirm that, if
successful, this additional study, in combination with the
successful completion of the ongoing work related to the CMC
requests in the Complete Response Letter (CRL), would support
approval of a resubmitted ONS-5010 BLA. Outlook Therapeutics
continues to believe that the proposed clinical trial design as
included in the Type A meeting request would allow for completion
of the study and resubmission of the ONS-5010 BLA by the end of
calendar year 2024.
Outlook Therapeutics also submitted a Marketing
Authorization Application (MAA) in Europe, which was validated for
review in December 2022. The formal review process of the MAA by
the European Medicines Agency (EMA) Committee for Medicinal
Products for Human Use (CHMP) is underway with an estimated
decision date expected in the first half of 2024.
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 “believe,” “continue,”
“estimate,” “expect,” “may,” “intend,” “plan,” “potential,” “will,”
or “would” 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 CRL issued by the FDA,
including with respect to an additional clinical trial and CMC
issues, the timing for completion of an additional clinical trial
and resubmission of the BLA for ONS-5010, expectations concerning
decisions of regulatory bodies, and the timing thereof, plans for
potential commercial launch of ONS-5010, expectations concerning
the relationship with Cencora 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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