Takeda Pharmaceuticals has made an exclusive licensing agreement with Tesaro Pharmaceuticals for developing and commercializing Niraparib, a novel poly ADP-ribose polymerase (PARP) inhibitor.
Niraparib, first marketed in the U.S. in April under the brand name “Zejula,” has quickly become the most frequently prescribed PARP inhibitor.
It is the first and only PARP inhibitor that has received approval for the maintenance treatment of women with recurrent ovarian cancer. Tesaro’s development plan currently includes clinical trials of Niraparib in patients with ovarian, breast, and lung cancer.
Janssen Biotech has licensed rights to develop and commercialize Niraparib specifically for patients with prostate cancer worldwide.
Under the agreement, Takeda will gain exclusive commercial rights for all potential future Niraparib indications in Japan, and rights excluding prostate cancer in Korea, Taiwan, Russia and Australia. Takeda will be responsible for the development of Niraparib in Japan and the four countries, including all associated expenses. Tesaro will receive a $100 million upfront payment and is eligible to receive additional milestone payments.
The 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. It has yet to win approvals in these countries, though.
“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 Global Oncology Business Unit. “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.”
Mary Lynne Hedley, president of Tesaro, also expressed her enthusiasm to the project. “Tesaro is devoted to providing transformative therapies for people bravely facing cancer, and this partnership enables us to continue to globalize our mission,” she said.