Outlook Therapeutics Inc (OTLK)

[H2R]

(PDUFA) goal date of August 29, 2023

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license

ISELIN, N.J., Oct. 28, 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 that the U.S. Food and Drug Administration (FDA) has accepted for filing a Biologics License Application (BLA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.

“This BLA acceptance and PDUFA date are significant milestones in our mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD,” said Russell Trenary, President and CEO of Outlook Therapeutics. “If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable. We estimate that approximately 50% of the millions of anti-VEGF injections in ophthalmology are off-label compounded bevacizumab that is administered with no FDA-approved labeling. That product configuration does not meet the same standards we must achieve to earn FDA approval in ophthalmology. We hope to enhance the standard of care in the anti-VEGF space, and we are proud of the entire team and our clinical partners and advisors for bringing ONS-5010 to this point in its journey towards FDA approval.”

“We are pleased the FDA has begun its review of our application. ONS-5010 is designed and manufactured to be fully compliant with the FDA’s criteria for ophthalmic intravitreal biologics and we are excited about the prospect of filling the public health need for an FDA-approved ophthalmic formulation of bevacizumab,” added Terry Dagnon, Chief Operations Officer of Outlook Therapeutics.

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 recently announced 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. Through this agreement, Outlook Therapeutics expects to increase market access and efficient distribution of ONS-5010, while not duplicating services provided by AmerisourceBergen, thereby decreasing Outlook’s otherwise needed expense for those same services.

Outlook Therapeutics also established best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance manufacturing, and with drug product manufacturer Ajinomoto Bio-Pharma Services for finished drug product.

In addition to the U.S. filing, 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 is assessing both direct commercialization and partnering in Europe and Asia on a country-by-country basis.

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