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 provided a business outlook for 2022.
“The past twelve months have been truly
transformational for Outlook Therapeutics. Building off of that
momentum, we continue to progress toward our targeted BLA
submission this quarter and ultimately potential FDA approval. Now
more than ever, we believe that ONS-5010 has the opportunity to
address a significant unmet need among the retina community and the
potential to provide physicians with a safe, effective, and
FDA-approved version of bevacizumab that meets standards required
for ophthalmic injections. With the potential for impactful
milestones on the horizon, we believe we are positioning ourselves
for success and remain dedicated to advancing this program to
unlock the full potential of Outlook Therapeutics,” commented Mr.
C. Russell Trenary III, President and Chief Executive Officer of
Outlook Therapeutics. “We look forward to an exciting year for
Outlook Therapeutics and our continued efforts to bring ONS-5010
for wet AMD over the finish line.”
ONS-5010 / LYTENAVA™
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an
investigational ophthalmic formulation of bevacizumab under
development to be administered as an intravitreal injection for the
treatment of wet age-related macular degeneration (wet AMD) and
other approved retinal diseases. Since no 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 pharmacists,
products that have risk of contamination and inconsistent potency
and availability. If approved, ONS-5010 will replace the need to
use unapproved repackaged IV bevacizumab from compounding
pharmacists for the treatment of wet AMD.
With the registration clinical trials now
completed, Outlook Therapeutics plans to submit a new BLA under the
Public Health Service Act (PHSA) 351(a) regulatory pathway in the
first quarter of calendar 2022. If the BLA is approved as
anticipated in the first quarter of calendar 2023, it is expected
to result in 12 years of marketing exclusivity for ONS-5010 as the
first and only ophthalmic formulation of bevacizumab approved by
the FDA to treat wet AMD.
As previously announced, if ONS-5010 receives
FDA approval, Outlook Therapeutics plans to file a supplementary
application for approval to provide the product in a pre-filled,
silicone oil free syringe that will meet the strict specifications
for ophthalmic use. In anticipation of potential approval, Outlook
Therapeutics is conducting NORSE SEVEN to compare the safety of
ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN will
enroll approximately 120 subjects with visual impairment due to
retinal disorders. Patients will be treated for three months and
the enrollment of patients in the arm of the study receiving
ONS-5010 in vials has been completed.
Upcoming Milestones
- Planned submission of new BLA to
the FDA in the first calendar quarter of 2022;
- Execution of the NORSE SEVEN study
evaluating Outlook Therapeutic’s vial delivery system versus a
pre-filled syringe of ONS-5010;
- Ongoing pre-launch commercial
planning underway in anticipation of potential ONS-5010 approval;
and
- Continued progress on preparation
for NORSE FOUR (BRVO) and NORSE FIVE AND SIX (DME) evaluating
ONS-5010 for additional ophthalmic indications.
“As we advance toward a potential commercial
launch of ONS-5010, we are working diligently to build the proper
infrastructure to support a launch in the U.S. This includes
onboarding our commercial team, expanding our operations team, and
collaborating with the retina community to provide education and
build awareness. Additionally, we are conducting our NORSE SEVEN
study to evaluate our vial delivery systems versus a pre-filled
syringe of ONS-5010. While not a gating item in our planned BLA
submission or potential approval, we believe that a pre-filled
syringe will be a key differentiator in the marketplace, providing
a more user-friendly delivery system designed for ophthalmic use,”
added Mr. Trenary.
Pre-Commercialization Planning
Underway
Per the National Eye Institute (NEI), use of
unapproved repackaged IV bevacizumab from compounding pharmacies is
estimated to account for at least 50% of all wet AMD prescriptions
in the United States each year. Globally, the nine major markets
account for an estimated $13.1 billion market for anti-VEGF drugs
to treat retina diseases.
In anticipation of potential FDA marketing
approval in 2022 for ONS-5010, Outlook Therapeutics has begun
commercial launch planning, including 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 has already commenced 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
shortly after completing the BLA submission. 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.
In addition to the clinical development program
evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received
agreements from the FDA on three Special Protocol Assessments
(SPAs) for three additional registration clinical trials. These
SPAs cover the protocols for a planned registration clinical trial
evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO,
NORSE FOUR) and two planned registration clinical trials evaluating
the drug candidate for the treatment of diabetic macular edema
(DME, NORSE FIVE and NORSE SIX). Outlook Therapeutics currently
expects to initiate registration clinical trials for ONS-5010 for
DME and BRVO in 2023 if FDA approval is received for the wet AMD
indication.
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 the 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, including
expectations of market exclusivity, the timing of BLA submission,
potential approval and commercial launch of ONS-5010, expectations
about the sufficiency of our capital, plans for and the timing of
potential future clinical trials, including the expected completion
of NORSE SEVEN, 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 to be 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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