Bristol-Myers Squibb ($BMY) has been leaning heavily on some of its other drugs since the blood thinner Plavix went off patent last year, leaving it shy of about $4.5 billion in revenues. Its leukemia drug Sprycel is one of those, and a labeling addition approved by the FDA Thursday can only help for a drug that already pulls in substantial revenues.
The company said Thursday that the FDA will allow it to add labeling that includes three-year efficacy and safety data for patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and 5-year data for the same patients who are resistant or intolerant to Novartis' ($NVS) Gleevec.
"CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Given the chronic nature of CML, these long-term data are particularly important for patient care," Dr. Neil Shah, associate professor, division of hematology/oncology, University of California, San Francisco, said in a statement.
Sales of Sprycel reached $287 million in the first quarter, up 24% from the same quarter a year ago. That accounted for 7.5% of first-quarter revenues for the company, Dow Jones reports. Sprycel revenues were just over $1 billion in 2012, up significantly from the $576 million it brought in in two years earlier. That only slightly offsets the revenues lost from the blood thinner Plavix, the superblockbuster that BMS shared with Sanofi ($SNY) until turning what is left of that product back to its partner last year. Bristol-Myers reported Plavix revenues of just $2.5 billion last year, compared with more than $7 billion in 2011.
BMS has patent exclusivity for Sprycel until 2020, but the company is fighting with India over its protection. The government said in January it intended to grant a compulsory license to an Indian drugmaker to produce a copy of Sprycel because it is too expensive in India but essential for treatment there.
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