Project name: ibrutinib
Peak sales estimate: $6 billion
Approved: Nov. 13
Companies: Pharmacyclics and Johnson & Johnson
A year ago, Pharmacyclics ($PCYC) and J&J ($JNJ) were among the first of the biopharma companies to be rewarded with the FDA's new breakthrough therapy designation for ibrutinib--on three different oncology indications. And in November the agency came through with an early approval for one of the most closely watched applications of the year for a new drug that has earned a steadily rising forecast for peak sales.
The therapy blocks a key enzyme involved in the growth of cancer and helped control the cases of 68% of 116 mantle cell lymphoma patients--with a relatively improved safety profile among treatment-resistant patients. The data have driven Pharmacyclics' shares to considerable heights, making CEO Robert Duggan a paper billionaire in the process.
J&J stepped in late in 2011, providing a rich $975 million deal to collaborate on development and marketing. The move demonstrated yet again the pharma giant's expertise at executing a blockbuster deal at the right moment.
About a month after the FDA's first approval for ibrutinib, investigators pulled back the results from a 27-month extension study of leukemia patients which helped illustrate this drug's potential. Virtually all of the treatment-naïve patients in the study continued to benefit from progression-free cases, with roughly three-quarters of the treatment-resistant patients seeing similar results.
Researchers told colleagues that about half of all leukemia patients would typically see disease progression after two years, making ibrutinib a standout. And with an absence of severe side effects, it appears to be the kind of drug that patients can take over a prolonged period. -- John Carroll (email | Twitter)
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