Item 7.01 - Regulation FD Disclosure.
On September 17, 2021, the European Medicines Agency ("EMA") published a letter
discussing certain Questions and Answers related to the withdrawal of Sesen Bio,
Inc.'s (the "Company") marketing authorization application ("MAA") for Vysyneum™
for the treatment of BCG-unresponsive non-muscle invasive bladder cancer
("NMIBC") per the EMA's standard practice and outlining the EMA's concerns with
Vysyneum based on its initial review of the MAA. A copy of the EMA's letter is
furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
As previously disclosed, the Company had received the Day 80 and Day 120 List of
Outstanding Issues from the EMA and was in the process of preparing responses,
which were due back to the EMA in early 2022, before voluntarily withdrawing its
MAA on August 20, 2021. The Company determined to withdraw the MAA following
feedback received from the US Food and Drug Administration ("FDA") regarding its
Biologics License Application for Vicineum™ for the treatment of
BCG-unresponsive NMIBC and while it waits for additional feedback from the FDA,
which the Company expects to receive at chemistry, manufacturing and controls
and clinical Type A meetings anticipated in the fourth quarter of this year.
The Company believes additional information from the FDA will equip the Company
to better synchronize the regulatory reviews of Vicineum for the treatment of
BCG-unresponsive NMIBC in the US and Europe. The Company intends to work closely
with the FDA to understand next steps.
Sesen Bio is committed to the highest standards of ethics and integrity and
continues to believe in the safety and efficacy data of Vicineum. Consistent
with our commitment to scientific integrity and thoroughness, the Company has
voluntarily engaged outside counsel and other experts to conduct a review
focusing on the conduct of, and data generated from, the clinical trials of
Vicineum, and the overall safety and effectiveness of Vicineum. The Company
expects outside counsel and other experts to work expeditiously to conduct the
review, determine the nature and scope of any issues identified, and advise on
any related disclosures.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, the Company's expectations that it will receive additional
feedback from the FDA regarding next steps for Vicineum for the treatment of
BCG-unresponsive NMIBC in the US, the Company's expectations regarding the
timing for the FDA's scheduling of Type A meetings with the Company, the
Company's belief that additional information from the FDA at the Type A meetings
will clarify the next steps for a potential regulatory path forward for Vicineum
in the US and equip the Company to better synchronize the regulatory reviews of
Vicineum in the US and Europe, the Company's intentions to work closely with the
FDA to understand next steps for Vicineum, the Company's commitment to ethics
and integrity, the Company's belief in the safety and efficacy data of Vicineum,
and the Company's internal review of the conduct of, and data generated from,
the clinical trials for Vicineum, and the overall quality, safety and
effectiveness of Vicineum, are based on the Company's current expectations and
inherently involve significant risks and uncertainties. The Company's actual
results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties,
including the risk that the FDA may not schedule Type A meetings with the
Company in the fourth quarter of this year, or at all, the risk that the Company
may not resume its plans to pursue regulatory approval for Vicineum in the US,
the risk that the Company may not resume its plans to pursue regulatory approval
of Vysyneum in Europe upon receiving additional feedback from the FDA, or at
all, the risk that the FDA may not approve the BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC if the Company resubmits the BLA at a future
time, the risk that the EMA may not approve the MAA for Vysyneum for the
treatment of BCG-unresponsive NMIBC if the MAA is submitted at a future time,
and the risk that the Company's internal review may uncover misconduct or other
improper activities by the Company's employees or third-parties involved in the
Company's clinical or regulatory activities related to Vicineum, among other
risks and uncertainties. A further description of the risks and uncertainties
relating to the business of the Company is contained in the Company's most
recent annual report on Form 10-K and the Company's quarterly reports on Form
10-Q, as well as any amendments thereto reflected in subsequent filings with the
SEC. The Company undertakes no duty or obligation to update any forward-looking
statements contained in this report as a result of new information, future
events or changes in its expectations.
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Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
Questions & Answers published by the European Medicines Agency on
99.1 September 17, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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