Outlook Therapeutics Expands Commercial Team with Appointment of Senior Vice President of Commercial Operations
February 08 2022 - 8:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to develop and launch the first FDA-approved
ophthalmic formulation of bevacizumab for use in
retinal indications, today announced the appointment of Joel
Prieve as Senior Vice President, Commercial Operations.
“Outlook Therapeutics is thrilled to welcome
Joel to our executive leadership team. We believe his background
and expertise in commercialization and specialty biopharmaceutical
distribution will be invaluable as we continue advancing our
pre-launch commercial planning in anticipation of potential
approval for ONS-5010 ophthalmic bevacizumab,” stated Jeff Evanson,
Chief Commercial Officer of Outlook Therapeutics.Mr. Prieve has
nearly twenty years of experience in commercial operations, most
recently in the Xcenda division of AmerisourceBergen as Vice
President of Business Development and previously in the IPN
Solutions division. Over the course of his career, he has amassed
valuable leadership experience in sales management and national
account management across oncology and specialty biopharmaceutical
markets. His expertise in Group Purchasing Organization (GPO)
contracting for retina/ophthalmology markets and his proven track
record of successful partnerships for new product launches will be
key for Outlook Therapeutics’ advancement of ONS-5010 / LYTENAVA™
(bevacizumab-vikg) towards potential commercialization.
In his new role as SVP of Commercial Operations,
Mr. Prieve will report to Jeff Evanson, Chief Commercial Officer of
Outlook Therapeutics, and oversee all aspects of distribution,
third-party logistics, HUB services and field resources to deliver
an industry-leading customer experience.
Mr. Prieve added, “I am delighted to join
Outlook Therapeutics at such an important stage of its development.
I look forward to working with Jeff and the rest of the team on the
potential commercial launch of ONS-5010.”
Outlook Therapeutics expects to submit a
Biologics License Application (BLA) for ONS-5010 ophthalmic
bevacizumab with the U.S. Food and Drug Administration (FDA) during
the first quarter of 2022. In anticipation of potential FDA
marketing approval in late 2022 or early 2023, Outlook
Therapeutics’ commercial launch planning includes manufacturing
with drug substance manufacturer FUJIFILM Diosynth Biotechnologies
and best-in-class drug product manufacturer Aji Biopharma Services,
distribution, sales force planning, physician and payor advisory
board outreach, key opinion leader support and payor community
engagement.
To bring ONS-5010 to market in a way that
benefits all stakeholders – patients, clinicians and payors –
Outlook Therapeutics is in collaborative discussions with payors
and the retina community. Outlook Therapeutics is also developing
registration documents on a parallel path for approvals in Europe
and expects to submit them in the fourth quarter of 2022. Outlook
Therapeutics continues to explore potential strategic
commercialization partners, such as Syntone Biopharma JV in China.
Outlook Therapeutics expects ONS-5010, if approved, to be a safe
and cost-effective choice for patients, clinicians and payors
worldwide for retinal indications
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)ONS-5010 is an investigational
ophthalmic formulation of bevacizumab under development to be
administered as an intravitreal injection for the treatment of wet
AMD and other retinal diseases. Because no currently approved
ophthalmic formulations of bevacizumab are available, clinicians
wishing to treat retinal patients with bevacizumab have had to use
unapproved repackaged IV bevacizumab provided by compounding
pharmacies, products that have known risks of contamination and
inconsistent potency and availability. If approved, ONS-5010 may
replace the need to use unapproved repackaged IV bevacizumab from
compounding pharmacies for the treatment of wet AMD.ONS-5010 is a
full-length, humanized anti-VEGF (Vascular Endothelial Growth
Factor) recombinant monoclonal antibody (mAb) that inhibits
VEGF and associated angiogenic activity. VEGF is a protein
that promotes the growth of abnormal new blood vessels and promotes
leakage from these vessels, leading to retinal edema and
hemorrhage. With wet AMD, abnormally high levels of VEGF are
secreted in the eye and lead to loss of vision. Anti-VEGF injection
therapy treats the vision-threatening leakage and hemorrhage as
well as blocks the growth of abnormal blood vessels. Since the
advent of anti-VEGF therapy, it has become the standard-of-care
treatment option within the retina community globally.About
Outlook Therapeutics, Inc.Outlook Therapeutics is a
biopharmaceutical company working to develop and launch 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. 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. Outlook
Therapeutics expects to submit ONS-5010 ophthalmic bevacizumab to
the U.S. FDA as a BLA under the PHSA 351(a) regulatory pathway. 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 “may,” “might,” “will,” “should,”
“expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,”
“predict,” “potential,” “intend” or “continue,” 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, including benefits
therefrom to patients, payors and physicians, the timing of BLA
submission, potential approval and commercial launch of ONS-5010,
potential strategic partners, plans for regulatory approvals in
other markets 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, 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,
2021 filed with the SEC and future quarterly reports we file with
the SEC, which include the uncertainty of future impacts related to
the ongoing COVID-19 pandemic. 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 PresidentLaVoie Health
ScienceT: 617-669-3082hullman@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
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