Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, and Hikma Pharmaceuticals, a
multi-national pharmaceutical company and leading licensing partner
in the Middle East and North Africa (“MENA”) region specializing in
the development and commercialization of a broad range of
high-quality medicines, today announced that the companies have
entered into an exclusive licensing agreement for the registration
and commercialization of Vicineum for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) and
other types of cancer in MENA. Vicineum, a locally administered
fusion protein, is Sesen Bio’s lead product candidate currently in
the follow-up stage of a Phase 3 registration trial for the
treatment of high-risk, BCG-unresponsive NMIBC. In December 2019,
the Company initiated the BLA submission for Vicineum to the FDA
under Rolling Review.
“Sesen is committed to saving
and improving the lives of patients, and Hikma is an ideal partner
to deliver Vicineum to patients with NMIBC in the MENA region,”
said Dr. Thomas Cannell, president and chief executive officer of
Sesen Bio. “As we continue to work toward regulatory approval in
the US and Europe, we also continue to execute partnerships outside
of the US as part of our mission to deliver this important medicine
to patients around the world. Hikma has strong expertise in
commercializing innovative products in the MENA region and a
successful track record of serving patients worldwide. This
partnership represents a further step in realizing the significant
global opportunity for Vicineum.”
“At Hikma, we believe that
partnerships with innovative pharma companies are a key contributor
to the success of our business. We are very pleased to enter into
an exclusive partnership with Sesen given their expertise in NMIBC
and the strong clinical profile of Vicineum,” said Mazen Darwazah,
Hikma’s Executive Vice Chairman and President of MENA. “As a
company whose mission is to put better health within reach every
day, we regard being the partner of choice to Sesen in MENA as a
key collaboration that augments Hikma’s biotechnology and oncology
portfolio to deliver on our strategy of bringing innovative
products to patients in the region. Vicineum - our first innovative
fusion protein - is a highly differentiated product candidate and
is positioned to make a meaningful impact on the lives of bladder
cancer patients.”
Under the terms of the
agreement, Sesen Bio granted Hikma an exclusive license to register
and commercialize Vicineum in all 19 MENA markets in an
arrangement anticipated to deliver equal value share to both
parties. Financial terms of the
agreement are confidential and include an upfront payment to
Sesen Bio, sales related milestone payments, and royalties on net sales in the region
for the term of the agreement. Sesen Bio retains full development
and commercialization rights for Vicineum for the treatment of
NMIBC in the US and the rest of the world excluding Greater China
and MENA.
Al-Tamimi and Hogan
Lovells acted as legal advisors to Sesen Bio for this
transaction.
About Vicineum™ Vicineum, a locally administered fusion
protein, is Sesen Bio’s lead product candidate currently in the
follow-up stage of a Phase 3 registration trial for the treatment
of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company
initiated the BLA submission for Vicineum to the FDA under Rolling
Review. 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 until it is internalized by the cancer cell, which 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 conducting the Phase 3 VISTA trial,
designed to support the registration of Vicineum for the treatment
of high-risk NMIBC in patients who have previously received a
minimum of two courses of bacillus Calmette-Guérin (BCG) and whose
disease is now BCG-unresponsive. 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. 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 Non-Muscle Invasive Bladder Cancer Bladder cancer
is the sixth most commonly diagnosed cancer in the United States,
and approximately 80 percent of patients have non-muscle invasive
bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of
the bladder or have grown into the lumen of the bladder but have
not spread into muscle or other tissue. NMIBC primarily affects men
and is associated with carcinogen exposure. Initial treatment
includes surgical resection; however, there is a high rate of
recurrence and more than 60 percent of all patients diagnosed with
NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy.
While BCG is effective in many patients, challenges with
tolerability have been observed and many patients will experience
recurrence of disease. If BCG is not effective or a patient can
longer receive BCG, the recommended option for treatment is radical
cystectomy, the complete removal of the bladder.
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 VB4-845, is currently in a Phase 3
registration trial for the treatment of high-risk, BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC). In December 2019, the
Company initiated the BLA submission for Vicineum to the FDA under
Rolling Review. Vicineum is a locally administered targeted fusion
protein composed of an anti-EpCAM antibody fragment tethered to a
truncated form of Pseudomonas Exotoxin A for the treatment of
high-risk NMIBC. For more information, please visit the company’s
website at www.sesenbio.com.
About Hikma Pharmaceuticals (LSE: HIK) (NASDAQ Dubai:
HIK) (OTC: HKMPY) (rated BBB-/stable S&P, BBB-/stable Fitch and
Ba1/stable Moody's)
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
more than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we are a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform
cutting-edge science into innovative solutions that transform
people's lives. We're committed to our customers, and the people
they care for, and by thinking creatively and acting practically,
we provide them with a broad range of branded and non-branded
generic medicines. Together, our 8,600 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner, and through our venture capital arm, are
helping bring innovative health technologies to people around the
world. For more information, please visit: www.hikma.com
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 “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,”
“should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: our ability to
successfully develop our product candidates and complete our
planned clinical programs, expectations regarding the safety and
efficacy of Vicineum, expectations regarding possible milestone and
royalty payments under the license agreement with Hikma,
expectations regarding Hikma’s ability to register and
commercialize Vicineum in MENA, expectations regarding potential
partnerships to develop and commercialize Vicineum outside of the
US, 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/20201201005641/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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