Pharmacyclics ($PCYC) and Johnson & Johnson ($JNJ) 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.
The drug, formerly ibrutinib, is a BTK-inhibitor designed to block the development of tumors tied to certain blood cancers. The FDA signed off on the treatment for mantle cell lymphoma, and, building off of an earlier partnership, Pharmacyclics is tasking Catalent to produce capsules of the drug for sale and further development.
For Pharmacyclics, Imbruvica's first approval was the result of years of development, and the biotech is reaching out to a partner it can trust with a full-scale commercial launch, Chief of Technical Operations Heow Tan said.
"It is important that we work with a development partner with expertise in both clinical and commercial supply as well as U.S. and worldwide GMP regulations, to ensure reliable quality supply to patients," Tan said in a statement. "Catalent's extensive experience will help us meet the demands of the clinical and commercial supply of ibrutinib."
The partnership centers on Catalent's accelerated development operation in Kansas City, a 450,000-square-foot facility that recently completed an FDA pre-approval inspection with zero recorded observations, the company said.
Catalent is also slated to pitch in on Imbruvica's ongoing trials, which are deeply important to the drug's future success. Imbruvica is expected to clear nearly $2 billion a year in sales by 2018, but that estimate relies on Pharmacyclics successfully broadening its indication: Mantle cell lymphoma affects only about 2,900 patients in the U.S. each year, and the drug's sales are unlikely to take off until Pharmacyclics can convince the FDA to approve it for the much more common chronic lymphocytic leukemia.
- read the statement