Date: Feb 12, 2014 Author: Ron Leuty Source: bizjournals (
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Ron Leuty
Pharmacyclics Inc. won its second Food and Drug Administration approval Wednesday for the cancer-fighting drug Imbruvica, netting the Sunnyvale company a $60 million milestone payment from a unit of Johnson & Johnson.
The pill, also known as ibrutinib, now can be used for patients with chronic lymphocytic leukemia, or CLL, who have received at least one previous therapy, the FDA said.
Genentech Inc.'s Gazyva won FDA approval in November as a first-line treatment for CLL, so patients who don't respond to Gazyva, which is infused, potentially could end up taking the Imbruvica pill. Gazyva is a set six-month course of treatment, while Imbruvica is designed to be taken until the cancer progresses.
Also on the horizon for CLL patients is idelalisib from Gilead Sciences Inc., which is under consideration by the FDA. It could be approved in September for a type of non-Hodgkin's lymphoma, but the Foster City-based company (NASDAQ: GILD) said late last year that it also will seek an FDA OK for the drug's use in relapsed CLL patients.
Imbruvica, which blocks an enzyme responsible for cancer cell growth and division, also won FDA approval in November to treat patients who received at least one prior therapy for mantle cell lymphoma, a rare and aggressive type of blood cancer.
Both of Imbruvica's approvals have come under FDA accelerated approval programs, which allows the agency to approve a drug based on a surrogate or intermediate endpoint that seems to indicate benefit.
Imbruvica, which is marketed by Pharmacyclics (NASDAQ: PCYC) and the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE: JNJ), sells for about $11,000 for a 30-day supply for mantle cell lymphoma patients. Because of a different dosage, it will sell for $8,200 a month for CLL patients.
Genentech's Gazyva costs $41,300 for its set six-month course.
But Pharmacyclics isn't stopping here. The company has seven Phase III trials of Imbruvica that cover all lines and various combinations of drugs, Pharmacyclics Chairman and CEO Robert Duggan said in a press release. The company also is in the clinic with three other drugs that attack a type of mantle cell lymphoma, pancreatic cancer and autoimmune disorders.
Chronic lymphocytic leukemia is a rare blood and bone marrow disease that causes a gradual increase in white blood cells, called B lymphocytes. About 15,680 people in the United States were diagnosed with the disease last year and 4,580 died.
The most common side effects in Pharmacyclics' 49-patient Phase Ib/II study, which was used to win FDA approval, included low levels of platelets int he blood, diarrhead, bruising, a decrease in infection-fighting white blood cells, low red blood cells, upper respiratory tract infection, fatigue, muscle, joint and bone pain, rash, fever, constipation, mouth sores, sinus infection and dizziness.
Ron Leuty covers biotech, higher education and China for the San Francisco Business Times.
