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Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.
On July 27, 2017, Takeda Pharmaceutical announced an exclusive licensing agreement with TESARO, a US-based oncology-focused biopharmaceutical company, for the commercialization and clinical development of niraparib, a poly ADP-ribose polymerase (PARP) inhibitor. The agreement includes the development of niraparib for treating all tumor types in Japan and all tumor types, excluding prostate cancer, in South Korea, Taiwan, Russia, and Australia.
Under the 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, in a company press release.
He also added: “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 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, a Johnson & Johnson company, 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, PhD, president and COO of TESARO, in a company press release. “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 was first marketed in the United States in April 2017 under the brand name “ZEJULA”, following approval by FDA in March 2017. Niraparib is not currently approved for use in Japan, South Korea, Russia, Taiwan, or Australia.
Source: Takeda Pharmaceutical