TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, and Medison Pharma Ltd., Israel's leading commercial
partner for innovative pharmaceuticals, today announced an
exclusive distribution agreement to commercialize ZEJULA®
(niraparib), an oral, once-daily poly (ADP-ribose) polymerase
(PARP) inhibitor, in Israel. ZEJULA is currently approved in the
United States and Europe as a monotherapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed
high-grade serous epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in complete response or partial response
to platinum-based chemotherapy, regardless of BRCA mutation or
biomarker status.
Under terms of the agreement, Medison will have
the exclusive right to commercialize ZEJULA in all indications,
excluding prostate cancer, in Israel. Medison will also be
responsible for any potential patient access programs prior to
regulatory approval. Further terms of the agreement were not
disclosed.
“TESARO is committed to globalizing our mission,
bringing transformative therapies to those facing cancer. This is
an important step forward for us and the many patients in Israel
who may benefit from ZEJULA,” said Orlando Oliveira, Senior Vice
President and General Manager, TESARO International. “We are proud
to enter this agreement with Medison which, alongside a track
record of bringing important therapies to patients across a number
of oncology indications, offers a tremendous potential for
collaboration as a source for innovation.”
“We are excited about the opportunity to provide
ZEJULA to cancer patients in our region. We plan to expedite access
to ZEJULA via an early patient access program and will work closely
with regulators to bring ZEJULA to patients here as quickly as
possible,” said Meir Jakobsohn, Founder and CEO, Medison Pharma.
"Through our corporate venture arm with a dedicated research team,
Medison partners with innovative biopharmaceutical companies,
providing us access to best-in-class assets across a number of
disease areas. We are happy to find in TESARO a partner that
understands the mutual value which can be achieved through
strategic collaboration.”
ZEJULA is not currently approved for use in
Israel.
About ZEJULA® (Niraparib)Niraparib is marketed in
the United States and Europe under trade name ZEJULA. ZEJULA
(niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor
indicated for the maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to platinum-based
chemotherapy. In preclinical studies, ZEJULA concentrates in the
tumor relative to plasma, delivering greater than 90% durable
inhibition of PARP 1/2 and a persistent antitumor effect.
ZEJULA is the most utilized PARP inhibitor among
women with ovarian cancer in the U.S., with more than 4,000
patients treated in 2017. Following European Commission
approval in November 2017, ZEJULA is the first and only PARP
inhibitor in Europe authorized for marketing for the maintenance
treatment of patients with recurrent ovarian cancer, regardless of
BRCA mutation status. TESARO’s clinical development program for
ZEJULA incorporates monotherapy and combination approaches for
multiple tumor types including ovarian, breast, and lung
cancer.
Janssen Biotech has licensed rights to develop
and commercialize ZEJULA specifically for patients with prostate
cancer worldwide, except in Japan. Takeda Pharmaceutical Company
Limited has licensed rights for all potential indications for
ZEJULA in Japan, as well as rights in South Korea, Taiwan, Russia
and Australia, excluding prostate cancer. TESARO has an agreement
with Zai Lab for the clinical development and co-marketing of
ZEJULA in China.
ZEJULA Select Important Safety
InformationMyelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML) was reported in patients treated with ZEJULA in some
clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and
neutropenia) have been reported in patients treated with
ZEJULA. Do not start ZEJULA until patients have recovered
from hematological toxicity caused by previous chemotherapy (≤
Grade 1). Monitor complete blood counts weekly for the first month,
monthly for the next 11 months of treatment, and periodically after
this time.
Hypertension and hypertensive crisis have been
reported in patients treated with ZEJULA. Monitor blood pressure
and heart rate monthly for the first year and periodically
thereafter during treatment with ZEJULA. Closely monitor patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can
cause fetal harm. Advise females of reproductive potential of
the potential risk to a fetus and to use effective contraception
during treatment and for six months after receiving the final
dose. Because of the potential for serious adverse reactions
in breastfed infants from ZEJULA, advise a lactating woman not to
breastfeed during treatment with ZEJULA and for one month after
receiving the final dose.
About TESAROTESARO is an
oncology-focused biopharmaceutical company dedicated to improving
the lives of cancer patients by acquiring, developing and
commercializing safer and more effective therapeutics. For more
information, visit www.tesarobio.com, and follow us on Twitter and
LinkedIn.
About MedisonMedison, Israel’s
leading innovative pharmaceutical partner, is an exclusive Israeli
partner for global healthcare companies such as Amgen®, Biogen®,
Ipsen®, Servier®, Array Biopharma®, Puma Biotechnology® and more.
Backed by three generations of experience in the healthcare
industry since 1937, Medison has built and maintained long-standing
relations with HMOs, local medical centers and physicians. Medison
is uniquely qualified to provide the complete spectrum of
integrated services for international companies looking to enter or
expand their presence in the Israeli market. Medison runs a
corporate venture arm with a dedicated research team boasting deep
scientific and commercial backgrounds. Medison's corporate venture
arm operates a scouting program to cater its partners, and is an
active investor in life science projects around drug development
and digital health.
TESARO Forward Looking
StatementsTo the extent that statements contained in this
press release are not descriptions of historical facts regarding
TESARO, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," and similar expressions (as well as other
words or expressions referencing future events, conditions, or
circumstances) are intended to identify forward-looking statements.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding the potential
commercialization of niraparib in Israel, and our niraparib
clinical development strategy. Forward-looking statements in this
release involve substantial risks and uncertainties that could
cause our research and development programs, clinical results,
regulatory outcomes, and financial and other results, performance,
or achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among other risks related to the acceptance
of niraparib in the marketplace, competition, the uncertainties
inherent in the execution and completion of clinical trials,
uncertainties surrounding the timing of availability of data from
clinical trials, uncertainties surrounding potential actions by
regulatory authorities, uncertainties regarding the expected timing
and magnitude of certain expenditures, risks related to
manufacturing and supply, risks related to intellectual property,
and other matters that could affect our financial results, the
results of our ongoing and planned development programs, and/or the
availability or commercial potential of our products and drug
candidates. TESARO undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of the Company in general, see
TESARO's Annual Report on Form 10-K for the year ended December 31,
2017.
TESARO Global Investor and Media
ContactJennifer DavisVice President, Corporate Affairs
& Investor
Relations+1-781-325-1116jdavis@tesarobio.comTESARO Media
Contact Outside the U.S.:Shannon AltimariHead of Corporate
Affairs, International+41 (0) 41 588 08
68saltimari@tesarobio.com
Medison ContactGil GurfinkelVice President,
Corporate Development+972 (0) 3 9250 374Gil@medison.co.il
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