NASDAQ OMX

TESARO and Medison Enter Into Exclusive Distribution Agreement to Commercialize ZEJULA® in Israel

Dela
  • 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

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

HotDocs Wins Prestigious Queen's Award for Enterprise for International Trade26.4.2018 09:01Pressmeddelande

EDINBURGH, United Kingdom, April 26, 2018 (GLOBE NEWSWIRE) -- HotDocs, the global leader in document automation software powered by AbacusNext, has been named a winner of the 2018 Queen's Awards for Enterprise, the UK's highest accolade for business success. HotDocs received the award for achievement in International Trade in recognition of thriving overseas growth, accounting for an over seventy percent increase in revenue in the last three years. Since 1965, the Queen's Awards have recognised exceptional UK businesses who excel at international trade, innovations, or sustainable development-they are the highest official UK awards for enterprise excellence. HotDocs will be attending a reception at Buckingham Palace where Prince Charles will present the award on behalf of Her Majesty the Queen. This is HotDoc's second Queen's Award for Enterprise, the first was in 2013, also for excellence in International Trade. "We are proud to have been named a Queen's Award winner for the second ti

Historic GSA Meeting Forges Path for Blockchain Technology in Gaming Industry26.4.2018 09:00Pressmeddelande

LONDON, April 26, 2018 (GLOBE NEWSWIRE) -- The Gaming Standards Association's (GSA) recently formed Blockchain Technical Committee held its first meeting in London recently, charting a course to integrate the breakthrough technology into the gaming industry, with the potential to modernize lotteries and online and land-based gaming. The meeting was hosted by Playtech and attending were representatives from member companies, AxesNetwork, ComTrade Gaming, Gaming Laboratories International, Mercury Gaming Gauselmann, IGT, and Scientific Games. The topics of discussion included responsible gaming, machine certification, and jurisdictional licensing. "The spirit of collaboration among the members of this committee was groundbreaking, as everyone understands the mission critical responsibilities for the future of the global gaming industry," said Blockchain Committee Chair Earle G. Hall. "The enthusiasm and understanding of the task of the committee were infectious, and by the end of the day

SmartCash Highlights 2018 Initiatives to Accelerate Global Adoption, Recaps Key Achievements26.4.2018 09:00Pressmeddelande

Roadmap milestones focus on further scalability, merchant adoption, security and support NEW YORK, April 26, 2018 (GLOBE NEWSWIRE) -- via NetworkWire -- SmartCash, a community governance, cooperation and growth focused crypto-asset created via blockchain technology, today provides an overview of its recent achievements and ambitions for the year ahead. Self-funded, Merchant-Centric, Community-Driven and Easy to Use Recent accomplishments have positioned SmartCash to become the ideal choice for making payments anywhere in the world by introducing the following: Username-based addresses vs. highly complex addresses of Bitcoin and other cryptocurrencies Self-funded model to ensure continual development and outreach Transaction fees of less than 1/10th a cent Advanced governance system to give every SmartCash holder a voice SmartNodes to enable InstantPay and other future services Easy-to-use web wallet and mobile app To learn more about SmartCash's innovations, visit https://smartcash.cc/

Medibio Announces Scientific Advisory Board26.4.2018 06:00Pressmeddelande

Led by Board of Director Franklyn Prendergast, M.D., Ph.D. and Chief Medical Officer Archie Defillo, M.D. Key external members include Martin Chapman, M.D.; Joel Ehrenkranz, M.D.; Mark A. Frye, M.D.; Lawrence Hunter, Ph.D.; Wallace Mendelson, M.D.; Marie Casey Olseth, M.D., and Giampaolo Perna, M.D., Ph.D. SYDNEY, Australia and MINNEAPOLIS, April 25, 2018 (GLOBE NEWSWIRE) -- Medibio Limited (MEB or the Company) (ASX:MEB) (OTCQB:MDBIF), a mental health technology company confirms establishment of its Scientific Advisory Board (SAB). Scientific Advisory Board Charter/Purpose The Medibio Scientific Advisory Board is charged to advise the board of directors and executive leadership team on scientific matters involving the Company's discovery and development of programs, including major internal projects, interactions with academic and other outside research organizations, and the acquisition of technologies. The SAB will assist directors and management to stay abreast of industry and menta

Madison Realty Capital Provides $35 Million Mezzanine Loan for 611 West 56th Street Condominium Development in Hell's Kitchen26.4.2018 00:51Pressmeddelande

Part of Overall $155 Million Financing Package Provided by MRC and Apollo Global Management for Planned 35 Story Condo Tower at 56th Street and Eleventh Avenue First New York City Project Designed by Renowned Architect Álvaro Siza NEW YORK, April 26, 2018 (GLOBE NEWSWIRE) -- Madison Realty Capital (MRC) provided a $35 million mezzanine loan to co-developers Sumaida + Khurana and LENY for a new condominium tower located at 611 West 56th Street in the Hell's Kitchen neighborhood of Manhattan. The funding is part of a $155 million construction financing package for the project provided by MRC and an investment fund managed by Apollo Global Management. Located in the evolving Hudson West neighborhood, 611 West 56th Street will stand 35 stories in height, encompass 163,329 square feet and feature 83 residences, ranging from one-bedrooms to expansive penthouses. The condominium will also feature a significant amount of outdoor space, including a landscaped roof garden and sun deck, as well a

Crocus Technology Raises $35M in Financing26.4.2018 00:36Pressmeddelande

Final round of financing to fuel Crocus' rapidly growing TMR magnetic sensor business SANTA CLARA, Calif., April 25, 2018 (GLOBE NEWSWIRE) -- Crocus Technology, a leading supplier of disruptive Tunnel Magneto-Resistance (TMR) sensors, today announces it has secured $35M in funding through a combination of debt and equity from internal investors and external sources. The funding will enable Crocus Technology to accelerate its revenue growth by expanding its operations and go-to-market resources and by investing in the continuous development of innovative products to serve the demand of existing and emerging markets. Crocus' proprietary MLU(TM) technology enables its TMR sensor products to have high magnetic sensitivity with minimal variation over a wide temperature range, coupled with ultra-low power consumption, which makes them ideal sensing solutions for IoT, mobile, automotive, medical and industrial applications. Crocus' TMR integrated sensor products are embedded within a CMOS pro

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum