Pharmacyclics and Servier are quietly walking away from a 5-year collaboration on a new cancer treatment, leaving the former company to go it alone on mid-stage oral drug with an uncertain future.
Johnson & Johnson's new blood cancer drug Imbruvica (ibrutinib) is on a roll. The FDA just armed the drug with a new indication in chronic lymphocytic leukemia, adding to a series of regulatory nods.
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.
Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status it was conceived for. The FDA Wednesday gave Imbruvica accelerated approval for treating chronic lymphocytic leukemia in patients who have received at least one previous therapy.
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Pharmacyclics and Johnson & Johnson are riding high on an accelerated approval for the blockbuster hopeful Imbruvica, and now they've tapped Catalent to aid in commercial manufacturing and ongoing clinical trials for the cancer drug.
Another cancer drug approval, another nosebleed-level price. Johnson & Johnson and Pharmacyclics' breakthrough drug Imbruvica (ibrutinib) won FDA approval yesterday for a rare form of lymphoma. Soon after, the companies said Imbruvica would be priced at more than $90 per pill. At four pills per day, that's about $130,000 per year.
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.
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.