Date: 2017-07-27
Type of information: Licensing agreement
Compound: niraparib
Company: Takeda Pharmaceutical (Japan) Tesaro (US - MA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing - devlopment - commercialisation
Action mechanism:
- poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Niraparib is an orally administered poly polymerase (PARP) inhibitor, currently in late-stage development for patients with metastatic breast cancer and ovarian cancer. PARP proteins play a key survival role in DNA repair in cancer cells. By inhibiting PARP, certain defective cancer cells are not able to repair themselves, leading to cell death. A portion of men with prostate cancer have these defective cancer cells and may benefit from use of a PARP inhibitor, either alone, or in combination with other treatments.
- Niraparib is approved for the maintenance treatment of women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status. It has been first marketed in the U.S. in April 2017 under the brand name Zejula™.
- 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, except in Japan.
Disease:
Details:
- • On July 27, 2017, Tesaro and Takeda Pharmaceutical announced 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. 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.
Financial terms:
- 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.
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