On April 06, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, reported a global collaboration and license agreement focused on the development and commercialization of niraparib specifically for the treatment of prostate cancer (Press release, TESARO, APR 6, 2016, View Source [SID:1234510485]). Niraparib is an oral, once daily, potent, and highly selective PARP inhibitor that is currently being evaluated in Phase 3 clinical trials for ovarian and breast cancer.
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"We are pleased to be working with Janssen, a leader in the prostate cancer field, to advance niraparib in this indication," said Lonnie Moulder, CEO of TESARO. "This innovative, indication-specific collaboration accelerates efforts to expand the treatment options available for men with prostate cancer and further increases the value of the niraparib franchise."
Under the terms of the agreement, Janssen will develop and commercialize niraparib for patients with prostate cancer worldwide, except in Japan. TESARO will receive an upfront payment of $35 million, and is eligible to receive additional milestone payments of up to $415 million, contingent upon Janssen reaching certain pre-determined development, regulatory and commercial milestones, in addition to tiered, double-digit royalty payments. Janssen will be responsible for funding all development and commercialization activities related to niraparib in prostate cancer. Separately, Johnson & Johnson Innovation — JJDC, Inc. is making a $50 million equity investment in TESARO at a price of $44.24 per share, which is based upon the 5-day volume weighted average share price through the day prior to execution of the agreement.
About Niraparib
Niraparib is an oral, once daily, potent, and highly selective PARP inhibitor that induces synthetic lethality in tumors cells with homologous recombination DNA repair deficiencies (HRD). The ongoing development program for niraparib includes a Phase 3 trial in patients with ovarian cancer (the NOVA trial), a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial), and a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial). In addition, a Phase 3 trial of niraparib in first-line ovarian cancer (PRIMA) and a Phase 1/2 clinical trial designed to evaluate the combination of niraparib plus KEYTRUDA (pembrolizumab) in patients with triple-negative breast cancer or ovarian cancer are planned to initiate shortly. Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus enzalutamide, bevacizumab, and temozolomide, in patients with prostate cancer, ovarian cancer, and Ewing’s sarcoma, respectively. Additional studies are being planned to evaluate niraparib in patients with lung cancer.