On April 11, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Medison Pharma Ltd., Israel’s leading commercial partner for innovative pharmaceuticals, reported an exclusive distribution agreement to commercialize ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, in Israel (Press release, TESARO, APR 11, 2018, View Source [SID1234525269]). 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.
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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 (≤ 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.