Hiring of the US sales force is 97% complete
and sales training has commenced
14 Key Opinion Leader (KOL) speakers have been
identified and speaker training has commenced
Two-pronged market access and reimbursement
strategy has commenced
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that it has completed its
commercial build phase in preparation for the anticipated launch of
Vicineum, if approved, in the US, and has advanced to the
implementation phase that will focus on executing the Company’s
commercial strategy for Vicineum. The Biologics License Application
(BLA) for Vicineum, the Company’s lead program, is currently under
Priority Review with the Food and Drug Administration (FDA) for the
treatment of BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC) in the US, with a target Prescription Drug User Fee Act
(PDUFA) date of August 18, 2021.
“We are thrilled to have this experienced commercial team on
board at Sesen Bio to build capabilities as we approach the
potential commercial launch of Vicineum in the US market,” said
Patricia Drake, chief commercial officer of Sesen Bio. “They have
made incredible progress across the core functions of sales,
marketing and market access. We also believe our network of Urology
and Uro-oncology KOL speakers will play an integral role in
allowing us to educate their peers about Vicineum, which we believe
will be a new tool in their practices to serve a large unmet
medical need in NMIBC.”
The Company has completed the hiring of ~25 talented internal
employees to support the Company cross-functionally, as well as the
hiring of 34 of 35 sales representatives as part of the contract
sales organization, which will be deployed across four
customer-centric regions and will target approximately 2,000
high-prescribers of BCG to drive awareness, trial and adoption of
Vicineum for the treatment of BCG-unresponsive NMIBC. If approved,
promotional efforts will begin immediately, and the Company expects
Vicineum product to be commercially available to physicians and
patients in the fourth quarter of 2021.
In addition to building its sales force, as part of Sesen Bio’s
national speaker programs, the Company has identified and commenced
training of 14 KOL speakers to engage physicians and educate them
on Vicineum for the treatment of BCG-unresponsive NMIBC.
Upon product availability, the Company will utilize a
two-pronged market access strategy to ensure maximum coverage for
Vicineum. The Company anticipates strong product reimbursement
achieved through the deployment of a focused team of National
Account Executives (NAEs) who will call on key commercial and
Medicare payers. The Company will also provide support to eligible
patients with a reimbursement services and support center, which
will help with benefit investigation, prior authorizations, a
co-pay assistance program, and any other support resources they may
require along their journey.
The Company believes it remains on track for an FDA decision on
its BLA for Vicineum by the target PDUFA date August 18, 2021.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Vicineum is comprised of a recombinant fusion protein that targets
epithelial cell adhesion molecule (EpCAM) antigens on the surface
of tumor cells to deliver a potent protein payload, Pseudomonas
Exotoxin A. Vicineum is constructed with a stable, genetically
engineered peptide tether to ensure the payload remains attached to
the antibody binding fragment until it is internalized by the
cancer cell. This fusion protein design is believed to decrease the
risk of toxicity to healthy tissues, thereby improving its safety.
In prior clinical trials conducted by Sesen Bio, EpCAM has been
shown to be overexpressed in NMIBC cells with minimal to no EpCAM
expression observed on normal bladder cells. Sesen Bio is currently
in the follow-up stage of a Phase 3 registration trial in the US
for the treatment of BCG-unresponsive NMIBC. In February 2021, the
FDA accepted for filing the Company’s BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC and granted the application
Priority Review with a target PDUFA date of August 18, 2021.
Additionally, Sesen Bio believes that cancer cell-killing
properties of Vicineum promote an anti-tumor immune response that
may potentially combine well with immuno-oncology drugs, such as
checkpoint inhibitors. For this reason, the activity of Vicineum in
BCG-unresponsive NMIBC is also being explored at the US National
Cancer Institute in combination with AstraZeneca’s immune
checkpoint inhibitor durvalumab.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company advancing
targeted fusion protein therapeutics for the treatment of patients
with cancer. The Company’s lead program, Vicineum™, also known as
oportuzumab monatox, is currently in the follow-up stage of a Phase
3 registration trial for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC). In February 2021, the
FDA accepted for filing the Company’s BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC and granted the application
Priority Review with a target PDUFA date of August 18, 2021. Sesen
Bio retains worldwide rights to Vicineum with the exception of
Greater China and the Middle East and North Africa (MENA), for
which the Company has partnered with Qilu Pharmaceutical and Hikma
Pharmaceuticals, respectively, for commercialization. Vicineum is a
locally administered targeted fusion protein composed of an
anti-EpCAM antibody fragment tethered to a truncated form of
Pseudomonas Exotoxin A, which is being developed for the treatment
of BCG-unresponsive NMIBC. For more information, please visit the
Company’s website at www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment
regarding the potential impact of the COVID-19 pandemic on our
Company. The Company has not yet experienced any disruptions to our
operations as a result of COVID-19, however, we are not able to
quantify or predict with certainty the overall scope of potential
impacts to our business, including, but not limited to, our ability
to raise capital and, if approved, commercialize Vicineum. Sesen
Bio remains committed to the health and safety of patients,
caregivers and employees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “expect,”
“anticipate,” “believe,” “may,” “target,” “strategy,” “potential,”
“will,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. For example, statements
regarding the timing for the FDA’s decision on the Company’s BLA
for Vicineum for the treatment of BCG-unresponsive NMIBC based on
the FDA granting the BLA Priority Review and the target PDUFA date
of August 18, 2021, the timing of the potential commercial launch
of Vicineum in the US, the Company’s beliefs regarding the ability
of Vicineum to serve unmet medical needs in NMIBC, the Company’s
expectations regarding the size, scope and ability to execute its
commercial strategy and promotion of Vicineum, if approved, in the
US market, the Company’s expectations regarding the timing for
availability of Vicineum, if approved, in the US, the Company’s
ability to ensure maximum coverage of Vicineum and its expectations
regarding reimbursement of Vicineum, and the impact of COVID-19 on
the Company, including its ability to raise capital, and, if
approved, its ability to commercialize Vicineum for the treatment
of BCG-unresponsive NMIBC. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: the risk that clinical
trials of Vicineum for the treatment of BCG-unresponsive NMIBC may
fail to demonstrate safety and efficacy to the satisfaction of the
FDA or not otherwise produce favorable results, the risk that the
FDA may not approve the BLA for Vicineum within the anticipated
timing, or at all, the risk that the Company may not be able to
establish sales, marketing and distribution capabilities, the risk
that the Company may not be successful in commercializing Vicineum
for the treatment of BCG-unresponsive NMIBC, if and when it is
approved, the risk that Vicineum may not gain market acceptance
among physicians, patients, third-party payors or the medical
community, the risk that Vicineum may become subject to unfavorable
pricing regulations, third-party coverage or reimbursement
practices or healthcare reform initiatives, the risk that Vicineum
for the treatment of BCG-unresponsive NMIBC may cause undesirable
side effects, serious adverse events or have other properties that
could delay or halt clinical trials, delay or prevent its
regulatory approval by the FDA, limit the commercial profile of its
labeling, if approved, or result in significant negative
consequences following any marketing approval, and other factors
discussed in the “Risk Factors” section of the Company’s Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other
reports filed with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent the Company’s views as of the date hereof. The
Company anticipates that subsequent events and developments will
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210726005194/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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