Recently, Bristol-Myers Squibb Co. (BMY) announced positive results from a late-stage study designed to evaluate its skin cancer drug ipilimumab in patients suffering from advanced melanoma. The 676 patients enrolled in the study, known as 020, were suffering from unresectable stage III or IV metastatic melanoma and had received prior therapies.
Bristol presented the data at the 46th Annual Meeting of the American Society of Clinical Oncology. The data were also published by the New England Journal of Medicine.
The patients were either treated with ipilimumab alone or in combination with a vaccine treatment called gp100, or solely with gp100. The randomized, double-blind global study revealed that patients treated with ipilimumab (either alone or in combination with gp100) survived for 10 months on average, as against average survival of six-and-a-half months in the group treated solely with the vaccine. The approximately four-month extension represented a 67% increase in survival.
After one year, approximately 44% to 46% patients treated with ipilimumab were alive as against 25.3% in the vaccine group. After two years, 24% patients treated with ipilimumab alone or in combination were alive, as against 14% of those treated solely with gp100.
The company, which acquired the drug through its acquisition of Medarex last year, intends to submit applications for marketing approval of ipilimumab in advanced melanoma later this year. Bristol is also evaluating the drug in lung cancer.
Melanoma is the deadliest form of skin cancer. According to data from the World Health Organization, approximately 132,000 new cases of melanoma are diagnosed annually across the globe. The incidence of melanoma has been on the rise since the 1970s. There were 68,720 new cases of melanoma in the U.S. as per the data from the American Cancer Society. The successful development of ipilimumab for skin cancer would go a long way in meeting this challenge.
Furthermore, Bristol-Myers got a boost when its cancer drug Sprycel was found to be more effective than Novartis’ (NVS) Gleevec for treating patients diagnosed newly with chronic myeloid leukemia as per a late-stage study.
Our Take
Even though patent expiration loom large on Bristol in the near future, we believe the company has taken some measures — like the Medarex acquisition, among others — to counter the loss of revenues resulting from the patent expirations of its key drugs.
The company intends to launch five other compounds — apixaban, belatacept, brivanib, dapagliflozin and ipilimumab — by 2012. The new launches are expected to drive growth in 2013 and beyond. We have a Neutral recommendation on the stock, which is supported by the Zacks #3 Rank.
Our Neutral stance on the New York-based company indicates that the stock is expected to perform in line with the U.S. equity market over the next six to twelve months. We advise investors to retain the stock over the time period.
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