Outlook Therapeutics Bolsters Clinical and Commercial Expertise with Two Key Appointments to Board of Directors
April 21 2020 - 8:05AM
Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced it has bolstered its Board of
Directors with the appointments of Prof. Dr. Gerd Auffarth and Mr.
Julian Gangolli.
“We are incredibly pleased to add individuals of
Dr. Auffarth’s and Mr. Gangolli’s caliber to the Outlook
Therapeutics Board of Directors,” stated Lawrence A. Kenyon,
President, CEO and CFO, Outlook Therapeutics. “We believe that the
significant R&D and clinical leadership and the knowledge of
the ophthalmology space that Dr. Auffarth brings, as well as the
deep commercialization expertise, including therapeutics for
retinal diseases, that Mr. Gangolli adds will be invaluable as we
advance our ongoing registration clinical trials for ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) towards commercialization.” Prof. Dr.
Auffarth is an internationally recognized ophthalmologist in the
area of research and development as well as clinical care for
patients. He currently serves as the Medical Director of
Heidelberg University Eye Clinic. Prior to his appointment as
Medical Director in 2011, he worked as a senior physician at the
University Eye Clinic. He currently serves as the Director of the
International Vision Correction Research Center (IVCRC) and the
David J. Apple Laboratory for Ocular Pathology, which he has
established in the University Eye Clinic and which are recognized
worldwide in the field of implant and biomaterial research. He is a
board member of the German (General Secretary) and the European
Society for Cataract and Refractive Surgery and is considered one
of the most experienced surgeons in cataract and corneal surgery.
As a co-founder of the Lions cornea bank in Heidelberg at the
Heidelberg University Eye Clinic, Prof. Dr. Auffarth continued to
advance transplant surgery (the human cornea) and innovative
research areas at the Heidelberg site. In 2004 he was appointed
Vice Chairman and Deputy Director of the Heidelberg Department of
Ophthalmology; he was awarded Extraordinary Professorship in the
Medical Faculty of the University of Heidelberg in May 2005. Mr.
Gangolli is a leader in commercialization with a well-established
track record and experience, having served as President of the
North American Pharmaceutical division of Allergan, Inc. for 11
years where he was a member of the Executive Committee of Allergan
and was responsible for a 1,400-person commercial operation with
sales exceeding $3.8 billion in 2014. Mr. Gangolli most recently
served as President, North America of Greenwich Biosciences, a GW
Pharmaceuticals PLC (NASDAQ: GWPH) Company, where he was
responsible for building out the U.S. commercial infrastructure and
spearheading the launch of its lead therapeutic product Epidiolex®.
Prior to that, Mr. Gangolli joined Allergan in 1998 and was a
senior member of the management team that transformed the company
into one of the leading specialty pharmaceutical companies in the
United States. As a member of the Allergan Executive Committee he
was part of the select team that executed the sale of Allergan to
Actavis in 2015.
In addition to joining the Outlook Board of
Directors, Mr. Gangolli currently serves as a Director on the Board
of two publicly traded pharmaceutical companies: Revance
Therapeutics (NASDAQ: RVNC) and Krystal Biotech (NASDAQ: KRYS).
About 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 retinal diseases. ONS-5010 is currently being evaluated
in two registration clinical trials for wet AMD (NORSE 1 and NORSE
2) and, if successful, is expected to be submitted to the U.S. Food
and Drug Administration (FDA) as a new biologics license
application (BLA) for this ophthalmic indication. If approved,
ONS-5010 will be the first and only FDA-approved ophthalmic
formulation of bevacizumab to treat approved retinal diseases. The
Company currently intends to commercialize ONS-5010 in both vials
and single-use pre-filled syringes.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (or mAb) that inhibits VEGF and associated angiogenic
activity. With wet AMD, abnormally high levels of VEGF are
secreted in the eye. VEGF is a protein that promotes the growth of
new abnormal blood vessels. Anti-VEGF injection therapy blocks this
growth. 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 late clinical-stage
biopharmaceutical company working to develop the first FDA-approved
ophthalmic formulation of bevacizumab for use in retinal
indications, including wet AMD, diabetic macular edema (DME) and
branch retinal vein occlusion (BRVO). If ONS-5010, its
investigational ophthalmic formulation of bevacizumab, is approved,
Outlook Therapeutics expects to commercialize it as the first and
only approved ophthalmic formulation of bevacizumab for use in
treating approved retinal diseases in the United States, 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 its
plans for filing a BLA for ONS-5010 / LYTENAVA™ (bevacizumab-vikg),
and expected commercialization plans for ONS-5010. Although the
Company believes that it has a reasonable basis for forward-looking
statements contained herein, they are based on current expectations
about future events affecting the Company 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 uncertainty regarding the
COVID-19 pandemic and its duration as well as those risks detailed
in the Company’s filings with the Securities and Exchange
Commission. 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. The Company 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 the Company’s
financial performance during the quarter, please see the Company’s
filings with the Securities and Exchange Commission.
CONTACTS: Outlook
Therapeutics:
Lawrence A. Kenyon LawrenceKenyon@outlooktherapeutics.com
Media Inquiries:Emmie TwomblyMedia Relations
SpecialistLaVoie Health ScienceM:
857.389.6042etwombly@lavoiehealthscience.com
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T:
833.475.8247OTLK@jtcir.com
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