Eventual winner Johnson & Johnson wasn't Pharmacyclics' first choice to partner with on ibrutinib, CEO Robert Duggan told FierceBiotech in January, but, as The Wall Street Journal lays out, J&J and its expansive approach to dealmaking won out in the end.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share. So here's my pick of the likely big winners >>
J&J knows how to do a big licensing deal with some serious short-term incentives tied to it. And that swaggering deal style was on full display this morning when Pharmacyclics announced that the FDA has accepted their NDA on the closely-watched cancer drug ibrutinib, triggering a $75 million milestone payment and bringing its cash tally to at least $375 million.
Two years ago, Quest Diagnostics picked up Celera and its gene-based testing tech for $657 million in cash. And today it cashed in a lottery ticket it picked up in the deal, selling the royalty rights Celera held for the breakthrough cancer drug ibrutinib for $485 million.
Ibrutinib notched another milestone in a fast trip toward FDA approval. Johnson & Johnson's Janssen has delivered the NDA for the closely watched cancer drug to U.S. regulators, setting the stage for a potential approval on the early side of the time line from the company and partner Pharmacyclics.
In our third annual report on 10 exciting cancer drugs, there are plenty of R&D programs zipping through trials with the blessing of the FDA, which has awarded "breakthrough" status for expedited development to treatments in oncology more than any other field. Read the report >>
Johnson & Johnson built its R&D rep around blockbuster development deals. Now the pharma giant's drug development arm wants the world to know that there's a comprehensive, global pipeline strategy in play that will deliver more than 10 new product applications over the next 4 years. And new drug development efforts in China and Japan are growing to rival the work it does in the U.S. and Europe.
Already sky-high expectations for the experimental cancer drug ibrutinib from J&J and Pharmacyclics managed to arc even higher this morning after the collaborators spread word that the program had just won its third "breakthrough drug" title from the FDA.
J&J and Pharmacyclics nabbed the FDA's new breakthrough designation for their cancer drug ibrutinib, a promising late-stage therapy that will be put in the hands of regulators later this year.
Pharmacyclics' closely watched leukemia drug ibrutinib has been attracting some strong buzz recently.