Johnson & Johnson’s Janssen Biotech will develop TESARO’s Phase III prostate cancer treatment niraparib worldwide except Japan under an up-to-$450 million collaboration.

TESARO, which announced the deal today, said Janssen will fund all development and commercialization activities related to niraparib in prostate cancer.

Janssen has agreed to pay TESARO $35 million upfront and up to $415 million in payments tied to achieving development, regulatory, and commercial milestones, plus tiered, double-digit royalties.

“This innovative, indication-specific collaboration accelerates efforts to expand the treatment options available for men with prostate cancer and further increases the value of the niraparib franchise,” TESARO CEO Lonnie Moulder said in a statement.

Niraparib is an oral, once-daily, potent, and highly selective poly(ADP ribose) polymerase (PARP) inhibitor now under study in Phase III clinical trials for ovarian and breast cancer.

In releasing fourth-quarter and full-year 2015 results on February 25, TESARO said it expected to release results from the Phase III NOVA and Phase II registrational QUADRA trials during the second quarter—the first data from a randomized, prospective Phase III trial of a PARP inhibitor, according to the company.

NOVA and QUADRA are designed to assess niraparib in patients with ovarian cancer. They are two of three registrational trials for niraparib; the third is the Phase III BRAVO trial assessing the compound in patients with BRCA-positive breast cancer.

Should trial results prove successful, TESARO has said it plans to file an NDA for niraparib with the FDA and a marketing authorization application (MAA) with the European Medicines Agency, in the second half of this year.

TESARO said plans also call for launching “shortly” the Phase III PRIMA trial of niraparib in first-line ovarian cancer, and a Phase 1/2 trial designed to evaluate the combination of niraparib plus KEYTRUDA® (pembrolizumab) in patients with triple-negative breast cancer or ovarian cancer.

TESARO will also receive a $50 million equity investment from J&J’s venture capital subsidiary, Johnson & Johnson Innovation–JJDC. The investment comes to $44.24 per share, which is based upon the 5-day volume weighted average share price through the day before execution of the agreement.








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