- Having locked down approval for its closely watched PARP inhibitor, Tesaro is turning to dealmaking as a means of building out its marketing and manufacturing capabilities.
- In an agreement announced on Thursday, Takeda Pharmaceutical handed over $100 million upfront in exchange for rights develop and commercialize Zejula (niraparib) in Japan, where it's headquartered, as well as Australia, Russia, South Korea and Taiwan. Tesaro could also snag up to $240 million in milestone payments, and stands to receive between mid-teens and low-thirties percent tiered royalties on net sales of the product.
- STA Pharmaceutical Co., a Chinese manufacturer of small molecule drugs, also entered an agreement with Tesaro. Announced Sunday, the deal has STA supplying both starting and intermediate materials for Zejula production over the next five years.
Zejula is the third drug in an emerging class of oncology treatments known as PARP inhibitors to break into the U.S. market. The Food and Drug Administration approved it in late March, a few months after green lighting Clovis Oncology's Rubraca (rucaparib) and a just shy of a few years after giving a thumbs up to AstraZeneca's Lynparza (olaparib).
Tesaro, therefore, has some ground to make up if it wants to pull ahead of rival companies' PARP products. Lynparza, for instance, has been prescribed to nearly 5,000 patients since its 2014 approval and is already available in 31 countries. Regulators from seven other nations were considering the drug for approval as of March 31, according to AstraZeneca's most recent Form 10-Q filing with the Securities and Exchange Commission.
Cementing an adequate supply of Zejula and forming partnerships to help market it should help in that effort.
With regard to the exclusive licensing agreement, Takeda has rights to commercialization Zejula for all tumor types in Japan and all tumor types except for prostate cancer in the other four countries. In the U.S., the drug so far is only approved for recurrent ovarian cancer.
"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," Mary Lynne Hedley, Tesaro's president and chief operating officer, said in a Thursday statement.
Though the company didn't break down what form the $100 million upfront payment would take in that statement, investment firm Jefferies said in a note the same day that the payment should give Tesaro adequate cash to operate through approximately 2018.
Jefferies also said the deal "indicates unlikely near-term buyout," of Tesaro, which the industry has labeled as a takeover target several times in the past.
The pact with STA, meanwhile, continues already fruitful collaboration. Both companies worked together for years during Zejula's clinical development and through regulatory approval, according to a July 23 statement from the Chinese manufacturer.
Interestingly, Tesaro announced its agreement with Takeda the same day that AstraZeneca revealed a partnership with Merck in which the companies will develop and commercialize Lynparza as a combo therapy with the PD-1/L1 inhibitors Keytruda (pembrolizumab) and Imfinzi (durvalumab).
Jefferies analyst Eun Yang highlighted in the July 27 note that Merck was the original developer of niraparib. The drugmaker is also working on a clinical collaboration with Tesaro pairing Zejula with Keytruda.