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Item 8.01 – Other Events.

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StockRoomBully   Sunday, 07/12/20 07:27:03 PM
Re: jjp2516 post# 976
Post # of 999 
Item 8.01 – Other Events.

On June 17, 2020, the U.S. Food and Drug Administration (“FDA”) informed Sesen Bio, Inc. (the “Company”) that the FDA has conditionally accepted the proprietary brand name VICINEUM™ for the Company’s product candidate, oportuzumab monatox.

The name VICINEUM was developed in compliance with the FDA’s final Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names and the FDA’s draft Guidance for Industry, Best Practices in Developing Proprietary Name for Drugs. The Company believes VICINEUM is a proprietary name with strong marketing potential that is also consistent with FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the VICINEUM brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox.

Based upon FDA feedback, the Company withdrew its previously submitted proposed brand name, VICINIUM®, from consideration due to potential for confusion with ammonium derivatives products with the “-ium” suffix as established by the United States Adopted Names Council.

VICINEUM is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer. In December 2019, the Company initiated the Biologics License Application (“BLA”) submission for VICINEUM to the FDA under Rolling Review. The Company expects to complete the VICINEUM BLA submission in the second half of 2020 and anticipates potential approval in first half of 2021.

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