Outlook Therapeutics® Strengthens Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs and Glen Olsheim, Executive Director of Commercial Excellence
January 19 2023 - 08:05AM
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 appointments of Surendra Sharma,
MD, as Senior Vice President, Medical Affairs, and Glen Olsheim as
Executive Director, Commercial Excellence.
“Outlook Therapeutics is very happy to welcome
Surendra and Glen to our growing executive leadership team. Their
respective backgrounds in directing the medical affairs of an
ophthalmic portfolio and of driving the successful launch and
commercialization of ophthalmic products will be tremendously
valuable as we move towards the commercial launch of ONS-5010
ophthalmic bevacizumab, pending its approval by the U.S. FDA,” said
Russell Trenary, President and Chief Executive Officer of Outlook
Therapeutics.
Dr. Sharma has more than 15 years of experience
in the pharmaceutical and biotechnology industries leading
corporate alliances among R&D, commercial, marketing and
business stakeholders. Most recently, he was Senior Medical
Director, Cornea, Dry Eye and Retina, Global Medical Affairs at
Santen Pharmaceuticals, Ltd. Over the course of his career at
companies including Spark Therapeutics, Inc., Biogen Inc., Alcon
Laboratories, Inc. and Regeneron Pharmaceuticals, Inc., he led
global scientific communications strategies designed to align and
meet the needs of key stakeholders in the North American and global
markets. Dr. Sharma’s ability to create and maintain key
relationships between the Company and key opinion leaders, the
medical and scientific community, patients and advocacy groups,
health authorities, and regulatory agencies will be instrumental
for Outlook Therapeutics’ potential launch and commercialization of
ONS-5010 ophthalmic bevacizumab. In his new role as SVP of Medical
Affairs, Dr. Sharma will report to Russ Trenary, President and
Chief Executive Officer of Outlook Therapeutics.
Dr. Sharma commented, “I am excited to join
Outlook Therapeutics at this important inflection point in the
Company’s development of ONS-5010, which I anticipate will offer an
important new therapeutic bevacizumab option to retina patients,
that is designed to actually meet standards required for ophthalmic
approval. I look forward to leading an integrated effort that
aligns the interests of both internal and external stakeholders to
create a win-win for Outlook Therapeutics and its
stakeholders.”
Mr. Olsheim brings to Outlook Therapeutics more
than 15 years of product commercialization experience in
ophthalmology. Prior to joining Outlook Therapeutics, in his role
as the VP of Business and New Product Development at Fagron Sterile
Services, he focused on driving revenue, profit and value in
repackaging IV bevacizumab for ophthalmic use in retina
indications. His familiarity with marketing these off-label
products for sale to ophthalmologists brings specific focus to his
strong network of industry contacts from major eye institutes and
hospitals. His experience and networks will be important for the
potential launch and commercialization of ONS-5010 ophthalmic
bevacizumab. In his new role as Executive Director of Commercial
Excellence, Mr. Olsheim will report to Jeff Evanson, Chief
Commercial Officer of Outlook Therapeutics, to help deliver an
industry-leading customer experience.
“I am delighted to join the growing Outlook
Therapeutics team that includes a group of dynamic industry
veterans looking to enhance the standard of care in the anti-VEGF
space,” said Mr. Olsheim. “I believe my familiarity with the
processes for repackaging IV bevacizumab for retinal use
complemented by my experience in launching ophthalmic products and
commercializing them at scale is well-aligned with Outlook
Therapeutics’ needs as it moves toward the potential commercial
launch of ONS-5010.”
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic
formulation of bevacizumab under development 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 can replace the need to use
unapproved repackaged oncologic IV bevacizumab from compounding
pharmacies for the treatment of wet AMD.
Bevacizumab-vikg is a recombinant humanized
monoclonal antibody (mAb) that selectively binds with high affinity
to all isoforms of human vascular endothelial growth factor (VEGF)
and neutralizes VEGF’s biologic activity through a steric blocking
of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR
(VEGFR-2) on the surface of endothelial cells. Following
intravitreal injection, the binding of bevacizumab-vikg to VEGF
prevents the interaction of VEGF with its receptors on the surface
of endothelial cells, reducing endothelial cell proliferation,
vascular leakage, and new blood vessel formation in the
retina.
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. The FDA accepted Outlook Therapeutics’ BLA submission
for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29,
2023. The submission is supported by Outlook Therapeutics’ wet AMD
clinical program, which consists of three clinical trials: NORSE
ONE, NORSE TWO, and NORSE THREE. 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, and in
anticipation of potential FDA approval in August 2023, Outlook
Therapeutics and AmerisourceBergen have entered into a strategic
commercialization agreement to expand the Company’s reach for
connecting to retina specialists and their patients.
AmerisourceBergen will provide third-party logistics (3PL) services
and distribution, as well as pharmacovigilance 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,” “expect,” “look
forward,” “plan,” “potential,” “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, the services to be provided under
Outlook’s partnership with AmerisourceBergen and the anticipated
benefits thereof, expectations regarding a commercial launch of
ONS-5010, 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, including the Annual Report on Form 10-K for the fiscal
year ended September 30, 2022, which include the uncertainty
of future impacts related to the ongoing COVID-19 pandemic and
other macroeconomic factors. 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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