Takeda Pharmaceutical and Tesaro, a biopharmaceutical company focused on oncology, have formed an exclusive licensing agreement for the commercialization and clinical development of niraparib, a poly ADP-ribose polymerase (PARP) inhibitor 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.

Niraparib was approved by the US Food and Drug Administration in March 2017 under the brandname Zejula for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. The drug is pegged by some analysts as a potential blockbuster. A recent analysis by Clarivate Analytics projects 2021 sales at nearly $1.1 billion.

Tesaro’s development plan currently includes clinical trials of niraparib in patients with ovarian, breast, and lung cancer. Janssen Biotech, part of Johnson & Johnson, has licensed rights worldwide (except in Japan) to develop and commercialize niraparib for treating prostate cancer.

Niraparib is not currently approved for use in Japan, South Korea, Russia, Taiwan, or Australia.

Source: Takeda Pharmaceutical