Nasdaq GlobeNewswire

TESARO and Takeda Enter Into Exclusive Licensing Agreement to Develop and Commercialize Novel Cancer Therapy Niraparib in Japan

Del

-   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@tesarobio.com

Takeda Contacts

Japanese Media:
Tsuyoshi Tada
Tel: +81 (0) 3-3278-2417
tsuyoshi.tada@takeda.com

Media Outside Japan:
Shawn Goodman
+1 (617) 444-1250
shawn.goodman@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

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Kofax Intelligent Automation Deployment at Davies Turner Wins Ventana Award for Overall Digital Leadership17.10.2018 12:00Pressemelding

Project Recognized for Driving Real-Time Insight into Shipments and Inventory to Transform the Customer Experience; Other Kofax Customers also Receive Accolades IRVINE, Calif., Oct. 17, 2018 (GLOBE NEWSWIRE) -- Kofax ® , a leading supplier of intelligent automation (IA) software to digitally transform end-to-end business processes, today announced its customer Davies Turner, one of the UK’s leading multimodal freight forwarding and logistics companies, won the 2018 Overall Digital Leadership Award from Ventana Research for its successful implementation of Kofax Intelligent Automation. Kofax customers Pinnacol Assurance and PITT-OHIO were also recognized. “Davies Turner’s commitment to automation was ambitious but the perfect match for Kofax Intelligent Automation,” said Reynolds C. Bish, Chief Executive Officer of Kofax. “This award is a great illustration of how Kofax enables increased productivity to help organizations remain on track for profitable growth and significant competitive

2018 European Cost Insight Product Cost Management Conference17.10.2018 10:00Pressemelding

Companies from Across Europe to Gather and Discuss How PCM Strategies & Technologies Improve Profitability & Accelerate Design to Delivery Time CONCORD, Mass., Oct. 17, 2018 (GLOBE NEWSWIRE) -- aPriori, the leading provider of enterprise product cost management (PCM) software solutions, announces today that it will host the European Cost Insight Product Cost Management Conference on November 26-28, 2018. This year’s event is being held at Hilton Amsterdam Airport Schiphol in Amsterdam, The Netherlands. This event is open to both aPriori customers and representatives from any manufacturers that are interested in learning more about product cost management technology and best practices. Visit the Cost Insight 2018 Event Website for complete information and register for this year’s program. Why Should You Attend Cost Insight 2018? As pressure increases to deliver innovative and customized products to market faster, manufacturers are struggling to maintain product profits and accelerate de

In-Memory Computing Summit North America 2018 Lays Out Vision for Digital Technology Evolution, Provides Practical Advice for Addressing Performance and Scalability Challenges17.10.2018 09:00Pressemelding

Keynotes, Breakout Sessions from Industry Leaders and Technology Experts Offer Actionable Advice on Navigating the Trends, Challenges and Solutions of Digital Transformation FOSTER CITY, Calif., Oct. 17, 2018 (GLOBE NEWSWIRE) -- GridGain® Systems, provider of enterprise-grade in-memory computing solutions based on Apache® Ignite™, today discussed the success of the fourth annual In-Memory Computing Summit® North America, which took place October 2-3, 2018 at the Hyatt Regency San Francisco Airport. The In-Memory Computing Summits (IMCSs), held annually in Europe and North America, are the only industry-wide events focusing on the full range of in-memory computing technologies and solutions. Nearly 450 people representing 227 organizations from 10 countries across 4 continents and 19 U.S. states registered to listen to speakers from American Airlines, ING Belgium, Intel Corp., Oracle, Salesforce.com, Huawei, SNIA, Wellington Management, GridGain Systems and many more. Recordings and sli

IMRALDI™, Biogen’s Adalimumab Biosimilar Referencing Humira®, Is Launched in the European Union17.10.2018 08:00Pressemelding

IMRALDITM is approved in the European Union for the same 14 complex autoimmune conditions as its reference product In 2017 Biogen became the first company in Europe with approved biosimilars referencing the three most prescribed anti-TNF biologic treatments BAAR, Switzerland, Oct. 17, 2018 (GLOBE NEWSWIRE) -- Samsung Bioepis Co. Ltd, a joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB) today announced the European launch of IMRALDITM, an adalimumab biosimilar referencing Humira®.1 IMRALDI is approved in Europe for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis. The launch of IMRALDI completes Biogen’s portfolio of three anti-TNF biosimilars in Europe, with BENEPALITM (etanercept), a biosimilar referencing Enbrel® 2, and FLIXABITM (inflixi

Atico Produces 5.36 Million Pounds of Cu and 3,010 Ounces of Au in Third Quarter 201816.10.2018 22:30Pressemelding

VANCOUVER, British Columbia, Oct. 16, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the “Company” or “Atico”) (TSX.V: ATY | OTC: ATCMF) announces its operating results for the three months ended September 30, 2018 from its El Roble mine. Production for the quarter totaled 5.36 million pounds of copper and 3,010 ounces of gold in concentrates, an increase of 5% for copper and 6% for gold, respectively, over the same period in 2017. “We are pleased to report another strong quarter of production as the El Roble mine continues to operate at a steady state level while the Company remains on track to deliver on our 2018 operational objectives,” said Fernando E. Ganoza, CEO. “For remainder of the year, we will continue optimizing the operation and executing the aggressive exploration drilling program at the El Roble property looking for additional mineralization both regionally and at mine vicinity.” Third Quarter Operational Highlights Production of 5.36 million pounds of copper contain

SoftServe’s Research Team Takes Prize at Samsung AI Challenge16.10.2018 21:16Pressemelding

Artificial intelligence leveraged to deblur and dehaze photos and videos with exceptional quality AUSTIN, Texas, Oct. 16, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announced its researchers won second place at the Samsung AI Challenge 2018 with innovative neural image restoration enhancement for mobile and embedded devices. “Artificial intelligence is at the center of future-proofing technologies for many businesses today,” said Serge Haziyev, senior vice president for Advanced Technology at SoftServe. “The opportunities for AI are endless and we are proud of our team and their commitment to creating an innovative AI algorithm that pushed the boundaries of existing deblurring and dehazing technologies as part of Samsung’s AI Hackathon.” The winning team, made up of SoftServe research engineers, Volodymyr Budzan and Orest Kupyn, participated in the worldwide event developing a solution that uses state-of-the-art deep learning and computer vi

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom