Outlook Therapeutics Expands Commercial Team with Appointment of Senior Vice President of Commercial Operations
Outlook Therapeutics has appointed Joel Prieve as the new Senior Vice President of Commercial Operations, bringing nearly 20 years of experience in commercial operations and specialty biopharmaceutical distribution. His role will be critical as the company anticipates submitting a Biologics License Application (BLA) for ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab, in Q1 2022. Outlook Therapeutics aims for a potential commercial launch in late 2022 or early 2023 and is also preparing for regulatory submissions in Europe.
- Joel Prieve's appointment brings extensive commercial operations expertise, particularly in specialty biopharmaceutical distribution.
- Outlook Therapeutics aims to submit a BLA for ONS-5010 in Q1 2022, positioning it for potential FDA approval and market launch.
- Plans for collaborations with payors and retina communities enhance ONS-5010's market readiness.
- Uncertainties regarding the timing of FDA approval and potential market competition for ONS-5010 may affect investor confidence.
- Joel Prieve brings nearly 20 years of commercial operations expertise and proven track record in sales and account management
ISELIN, N.J., Feb. 08, 2022 (GLOBE NEWSWIRE) -- 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 Ullman
Vice President
LaVoie Health Science
T: 617-669-3082
hullman@lavoiehealthscience.com
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com
FAQ
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