- Agreement covers all
indications for ZEJULA, excluding prostate cancer
ZUG, Switzerland and PETACH TIKVA,
Israel, April 11, 2018 (GLOBE NEWSWIRE) -- 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 Information
Myelodysplastic 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 (less than or equal to 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
TESARO
TESARO 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
Medison
Medison, 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 Statements
To 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 Contact
Jennifer Davis
Vice President, Corporate Affairs & Investor
Relations
+1-781-325-1116
jdavis@tesarobio.com
TESARO Media Contact Outside the
U.S.:
Shannon Altimari
Head of Corporate Affairs, International
+41 (0) 41 588 08 68
saltimari@tesarobio.com
Medison
Contact
Gil Gurfinkel
Vice President, Corporate Development
+972 (0) 3 9250 374
Gil@medison.co.il
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: TESARO, Inc. via Globenewswire
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