TESARO and Takeda Enter Into Exclusive Licensing Agreement to Develop and Commercialize Novel Cancer Therapy Niraparib in Japan
(Thomson Reuters ONE) -
- Takeda's Rights Include all Potential Indications for Niraparib in Japan and
Rights Excluding Prostate Cancer in South Korea, Taiwan, Russia and Australia
- TESARO to Receive $100 Million Upfront Payment and is Eligible for Future
Regulatory and Commercial Milestones, Plus Royalties
WALTHAM, Mass. and OSAKA, Japan, July 27, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc.
(NASDAQ:TSRO) and Takeda Pharmaceutical Company Limited (TSE:4502) today
announced an exclusive licensing agreement for the commercialization and
clinical development of niraparib, a novel poly ADP-ribose polymerase (PARP)
inhibitor. This agreement includes the development of niraparib for the
treatment of all tumor types in Japan, and all tumor types excluding prostate
cancer in South Korea, Taiwan, Russia and Australia. Niraparib, first marketed
in the U.S. in April under the brand name ZEJULA(TM), has quickly become the
most frequently prescribed PARP inhibitor in the U.S.
Under the terms of this agreement, TESARO will receive a $100 million upfront
payment and is eligible to receive additional milestone payments of up to $240
million related to the achievement of certain regulatory and commercial goals.
TESARO will also be eligible to receive from Takeda tiered royalties based on a
double digit percentage of net product sales. Takeda gains exclusive commercial
rights for all potential future niraparib indications in Japan, and rights
excluding prostate cancer in South Korea, Taiwan, Russia and Australia. Takeda
will be responsible for development of niraparib in Japan and the four specified
countries, including all associated expenses. Additional terms of this agreement
were not disclosed.
"The niraparib development program addresses many of the most prevalent and
devastating cancers worldwide. We must continue to make new treatments available
to patients and, through research, further our knowledge into the full utility
of this molecule," said Christophe Bianchi, President of Takeda Oncology. "We
are pleased to be collaborating with TESARO, a company we admire for its high
caliber oncology expertise. This agreement represents another step in our goal
of building Takeda's robust portfolio in solid tumors and, more importantly, our
commitment to patients living with cancer who desperately want - and need - new,
innovative therapies."
Once-daily niraparib is the first and only PARP inhibitor that has received
approval for the maintenance treatment of women with recurrent ovarian cancer,
regardless of BRCA mutation or biomarker status. TESARO's development plan
currently includes clinical trials of niraparib in patients with ovarian,
breast, and lung cancer. Janssen Biotech has licensed rights to develop and
commercialize niraparib specifically for patients with prostate cancer
worldwide, except in Japan.
"TESARO is devoted to providing transformative therapies for people bravely
facing cancer, and this partnership enables us to continue to globalize our
mission," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "As the
largest pharmaceutical company in Japan, Takeda is recognized as a leader in
oncology, and we are excited to work with the Takeda team to quickly advance
niraparib for patients who are in need of new treatment options."
Niraparib is not currently approved for use in Japan, South Korea, Russia,
Taiwan or Australia.
About ZEJULA (Niraparib)
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.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal
cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if
MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia
and neutropenia), as well as cardiovascular effects (hypertension and
hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor
complete blood counts to detect hematologic adverse reactions, as well as to
detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm
and females of reproductive potential should use effective contraception. Please
see full prescribing information, including additional important safety
information, available at www.zejula.com.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more information,
visit www.tesarobio.com, and follow us on Twitter and LinkedIn.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-
driven pharmaceutical company committed to bringing better health and a brighter
future to patients by translating science into life-changing medicines. Takeda
focuses its R&D efforts on oncology, gastroenterology and central nervous system
therapeutic areas plus vaccines. Takeda conducts R&D both internally and with
partners to stay at the leading edge of innovation. New innovative products,
especially in oncology and gastroenterology, as well as our presence in Emerging
Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are
committed to improving quality of life for patients, working with our partners
in health care in more than 70 countries. For more information,
visit http://www.takeda.com/news.
Additional information about Takeda is available through its corporate website,
www.takeda.com, and additional information about Takeda Oncology, the brand for
the global oncology business unit of Takeda Pharmaceutical Company Limited, is
available through its website, www.takedaoncology.com
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. Forward-looking statements in this
release involve substantial risks and uncertainties that could cause our
clinical development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, risks associated
with competition in the PARP market, risks related to pricing and reimbursement,
risks related to manufacturing and supply, risks related to intellectual
property, and other risks and uncertainties that could affect the availability
or commercial potential of niraparib in Japan, South Korea, Australia, Taiwan
and Russia. 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, 2016.
TESARO Contact
Jennifer Davis
Vice President, Corporate Affairs &
Investor Relations
781-325-1116
jdavis(at)tesarobio.com
Takeda Contacts
Japanese Media:
Tsuyoshi Tada
Tel: +81 (0) 3-3278-2417
tsuyoshi.tada(at)takeda.com
Media Outside Japan:
Shawn Goodman
+1 (617) 444-1250
shawn.goodman(at)takeda.com
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
Unternehmensinformation / Kurzprofil:
Datum: 27.07.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 554227
Anzahl Zeichen: 9227
contact information:
Town:
Massachusetts
Kategorie:
Business News
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