Pharmacyclics Inc. (PCYC:US), the cancer-drug developer partnered with Johnson & Johnson (JNJ:US), gained the most in four years after a trial of its leukemia medicine Imbruvica was stopped early because the therapy met study goals.
Pharmacyclics jumped 19 percent to $124.54 at 10:45 a.m. New York time, after touching $125.50 for its biggest intraday advance since Jan. 13, 2010. The stock of the Sunnyvale, California-based company had increased 68 percent in the 12 months through yesterday. J&J, based in New Brunswick, New Jersey, rose 1.7 percent to $93.91.
Imbruvica helped patients live longer without their cancer progressing compared with GlaxoSmithKline Plc (GSK)’s Arzerra, also known as ofatumumab, Pharmacyclics and J&J said in statements today. Imbruvica also showed improvement in overall survival and had an acceptable safety profile, the companies said.
“The study was statistically significant on both progression-free survival and overall survival at interim, which proves the strong efficacy of the drug,” Robyn Karnauskas, an analyst with Deutsche Bank in New York, wrote in a research note today.
The 391-patient trial, called Resonate, was in the last of three stages of clinical studies generally required for regulatory approval. It was halted on the recommendation of an independent data monitoring committee, which also suggested Imbruvica be made available to patients who had been taking ofatumumab in the trial.
Imbruvica was approved in the U.S. in November as a breakthrough therapy for previously treated patients who have mantle cell lymphoma. The Resonate trial was in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, for which J&J and Pharmacyclics have also applied for approval.
“With the positive data, we expect the off-label use of Imbruvica in CLL to increase,” Karnauskas said. She estimates about 35 percent to 40 percent of Imbruvica use is in CLL, meaning doctors are prescribing the drug for that disease before the therapy has received regulatory approval.
The Food and Drug Administration is expected to reach a decision on that indication by the end of February. Analysts estimate (PCYC:US) Imbruvica will draw $4.8 billion in revenue, on average, in 2020 for Pharmacyclics.
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