LICENSING AGREEMENT WITH TAKEDA
In July 2017, TESARO and Takeda entered into 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 20174 under the brand name ZEJULA™, 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.
GLOBAL COLLABORATION & LICENSING AGREEMENT WITH JANSSEN
In April 2016, TESARO and Janssen Pharmaceutical Companies of Johnson & Johnson announced a global collaboration and license agreement focused on the development and commercialization of niraparib specifically for the treatment of prostate cancer. 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.
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.
COLLABORATION AGREEMENT WITH MD ANDERSON
In March 2016, TESARO entered into an exclusive collaboration agreement with the Institute for Applied Cancer Science at the University of Texas MD Anderson Cancer Center to discover and develop small molecule product candidates against undisclosed immuno-oncology targets. This collaboration leverages MD Anderson’s expertise in drug discovery and translational medicines and TESARO’s oncology drug development and commercialization capabilities.
Under terms of the agreement, TESARO will receive exclusive worldwide rights to develop and commercialize any small molecule product candidates that result from this collaboration. MD Anderson will be responsible for conducting research activities aimed at identifying clinical candidates with defined characteristics targeting certain immuno-oncology targets. TESARO will fund research, development, and commercialization expenses for this collaboration. Additional terms of this agreement were not disclosed.
LICENSE AGREEMENT WITH ANAPTYSBIO
In March 2014, TESARO entered into a license agreement with AnaptysBio by which we obtained exclusive, worldwide rights to monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1 and dual reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Therapeutic antibodies selected from these programs will form the basis of a strategic platform that will enable TESARO to develop novel monotherapy and combination-based approaches with immuno-oncology and other anti-cancer agents in a variety of indications.
This agreement was structured to include an up-front payment to AnaptysBio in connection with initiation of the license agreement, in addition to milestone payments for achievement of certain development, regulatory and sales objectives and royalties based on worldwide annual net sales. AnaptysBio and TESARO will together complete preclinical development of the antibody candidates, with TESARO being solely responsible for all clinical development, manufacturing, regulatory and commercial activities.
LICENSE AGREEMENT WITH MERCK
In May 2012, TESARO entered into a license agreement with Merck Sharp & Dohme Corp., a subsidiary of Merck, under which we obtained exclusive, worldwide rights to certain patents and non-exclusive rights to certain Merck know-how, to research, develop, manufacture, market and sell niraparib and a backup compound, MK-2512, for all therapeutic and prophylactic uses in humans. This agreement was structured to include an up-front payment to Merck of in connection with initiation of the license agreement, in addition payments for achievement of certain development, regulatory and sales objective milestones and royalties based on worldwide annual net sales.
TESARO is responsible for all clinical, regulatory and other activities necessary to develop and commercialize niraparib. At the time of the license transaction, niraparib had completed a Phase 1 clinical trial in cancer patients as a monotherapy.
LICENSE AGREEMENT WITH OPKO HEALTH
In December 2010, TESARO and OPKO Health signed a definitive agreement granting TESARO exclusive rights for the development, manufacture, commercialization and distribution of rolapitant and a related compound. The terms of this agreement included an up-front payment to OPKO and additional potential payments based upon achievement of specified regulatory and commercialization milestones, in addition to double digit tiered-royalties on sales. TESARO and OPKO will share future profits from the commercialization of licensed products in Japan and OPKO will have an option to market the products in Latin America. In addition, OPKO acquired a 10% equity position in TESARO.
TESARO is responsible for all clinical, regulatory and other activities necessary to develop and commercialize rolapitant. At the time of the license transaction, rolapitant had completed Phase 2 clinical trials for prevention of chemotherapy-induced nausea and vomiting and was ready to begin Phase 3.