Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage
biopharmaceutical company developing the first FDA-approved
ophthalmic formulation of bevacizumab-vikg (LYTENAVA™) for use in
retinal indications (known as ONS-5010). Outlook Therapeutics is
advancing on multiple fronts, including: progress on its Phase 3
clinical program, manufacturing and regulatory activities, and
global strategic partnering negotiations, all leading to the
planned commercial launch of ONS-5010 anticipated in 2022. In
addition, Outlook Therapeutics recently completed a strategic
partnership for commercialization in Greater China and is in
discussions with other strategic partners for commercial launches
in the United States, Asia and Europe.
Clinical Progress
Drives ONS-5010 Towards U.S. and EU Filings in 2021Outlook
Therapeutics has already demonstrated both safety and efficacy
through a recently reported clinical experience trial and,
separately, has also completed enrollment of 227 patients in its
U.S.-based Phase 3 pivotal trial. The clinical experience trial
gives Outlook Therapeutics a high level of confidence in the
outcome of the ongoing fully-enrolled pivotal trial. Pivotal data
are expected mid-2021 followed by submission of a U.S. Biologics
License Application (BLA) to the U.S. Food and Drug Administration
(FDA). If the BLA is approved, it will result in 12 years of
marketing exclusivity. Outlook Therapeutics is on track for both
U.S. BLA filing and EU Marketing Authorization Application (MAA)
filings in 2021.
ONS-5010 Addresses Significant
Unmet Medical NeedAlthough unapproved repackaged
IV Avastin® from compounding pharmacists is widely used by retinal
specialists, extensive marketing research has indicated that there
is a significant unmet medical need for an approved ophthalmic
formulation of bevacizumab that removes both the product liability
and safety concerns of a repackaged product. Once approved, Outlook
Therapeutics’ ONS-5010 will reduce the need for use of unapproved
repackaged IV Avastin® from compounding pharmacists. Upon approval,
ONS-5010 will be the first ophthalmic formulation of
bevacizumab-vikg approved as an anti-VEGF therapy addressing vision
loss from wet age-related macular degeneration (wet AMD). Outlook
Therapeutics also intends to seek approval of ONS-5010 for other
approved indications, including branch retinal vein occlusion
(BRVO) and diabetic macular degeneration (DME).
Commercial
Planning Activities
UnderwayCommercial launch planning has begun,
including distribution, physician and patient outreach, key opinion
leader support and payor community engagement. With an
enhanced safety and cost-effective profile, Outlook Therapeutics
expects ONS-5010 to be widely adopted by payors and clinicians
worldwide and to become the first-line drug of choice for
payor-mandated “step edit” in the United States for retinal
indications.
Extensive market research indicates that
ONS-5010, if approved, will be a significant therapy in the retinal
anti-VEGF market, currently estimated to be in excess of $13
billion worldwide.
Manufacturing and Regulatory
Progress Towards CommercializationOutlook
Therapeutics is working with FujiFilm Diosynth Biotechnologies
(Fuji) and Ajinomoto Bio-pharma Services (AjiBio) to provide
product manufacturing in best-in-class cGMP global manufacturing
facilities. The Outlook Therapeutics strategy also provides greater
safety confidence to both clinicians and patients by reducing the
current practice of using compounding facilities, which have raised
concerns about product quality that impact patient safety. Outlook
Therapeutics has completed technology transfer and scale-up
consistent with global cGMP standards with both Fuji and
AjiBio.
Outlook Therapeutics also has executed a supply
agreement for a best-in-class pre-filled ophthalmic syringe that
will provide both ease-of-use for clinicians and add to ONS-5010’s
safety profile over the current unapproved therapies that have
caused problems related to syringe malfunction, contamination,
etc.
On the regulatory front, Outlook Therapeutics
has tentatively been granted an ATC code for ophthalmic bevacizumab
by the World Health Organization. Also, SME Entity Status has been
granted by the EMA.
Discussions with Potential Strategic
Partners ProgressingThe above
accomplishments and the potential of ONS-5010 have captured the
attention of potential strategic partners. Outlook Therapeutics is
engaged with several life sciences companies that could result in a
strategic partnership and definitive agreement for ONS-5010 as soon
as the end of 2020. Recently, Outlook Therapeutics announced a
joint venture with Syntone Technologies for commercializing
ONS-5010 in Greater China. Syntone Technologies also made a
substantial equity investment in Outlook Therapeutics. Outlook
Therapeutics anticipates similar interest from biologic commercial
partners in other countries.
About Outlook Therapeutics,
Inc.
Outlook Therapeutics is a late clinical-stage
biopharmaceutical company working to develop ONS-5010 / LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab-vikg for use in retinal indications, including wet
AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics
expects to commercialize it as the first and only FDA-approved
ophthalmic formulation of bevacizumab-vikg for use in treating
retinal diseases in the United States, United Kingdom, Europe,
Japan and other markets. Outlook Therapeutics expects to file
ONS-5010 with the U.S. FDA as a new 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 statements about the
timing of commercial launch of ONS-5010, the timing of completion
of, and safety and efficacy data from, the Phase 3 pivotal trial,
the timing of BLA and MAA submission for ONS-5010, ONS-5010’s
potential as the first FDA-approved ophthalmic formulation of
bevacizumab, including benefits therefrom to patients, payors and
physicians, the timing of entry into a strategic partnership and
definitive agreement with a global ophthalmic company, including
its ability to do so, plans for regulatory approvals in other
markets, and interest from OUS commercial partners. 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, and
risks of negotiating strategic partnership agreements, as well as
those risks detailed in Outlook Therapeutics’ filings with the
Securities and Exchange Commission, 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. For additional details on Outlook Therapeutics’ financial
performance during the quarter, please see the Outlook Therapeutics
filings with the Securities and Exchange Commission.
CONTACTS:Media
Inquiries:Jessica MorrisAccount ExecutiveLaVoie Health
ScienceT: 857.701.9731jmorris@lavoiehealthscience.com
Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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