Ipilimumab - FDA's Top 10 Blockbuster Decisions
Drug: Ipilimumab
Company: Bristol-Myers Squibb
PDUFA date: December 25
Peak sales: $1 billion - $1.5 billion
When IMS Health produced the latest bleak assessment of the patent cliff looming on Big Pharma's horizon, analysts wrapped up the review with a few of the brightest drug prospects that could help relieve the sting of lost revenue. Bristol-Myers Squibb's melanoma drug ipilimumab was one of its top five,
BMS landed ipilimumab back in 2009 with its buyout of Medarex, part of an aggressive strategy to remake its pipeline and grab ahold of some late-stage prospects with blockbuster revenue potential. It hasn't been disappointed by the cancer drug. Melanoma is one of the most lethal cancers, so when researchers pulled the veil back on data showing that the therapy significantly improved one- and two-year survival rates, chances of an approval shot up.
Forty-four to 46 percent of patients treated with the drug were alive at one year compared to 25 percent of patients treated with the control arm, BMS reported in June. At two years, 22 to 24 percent of patients treated with ipilimumab were alive compared to 14 percent of patients treated with the control arm.
Ipilimumab is by no means a miracle drug. It's been linked to severe, life-threatening side effects. But analysts have forecast peak sales of $1 billion to $1.5 billion based on its approval for patients with dwindling choices.
Ipilimumab is one of the latest of a string of antibody therapies to make its way through Phase III. Melanoma could be just its first indication as BMS works to get its mojo back in the cancer drug market. And BMS could be on a roll. The blood-clot drug apixaban could well be up for an approval next year, with more blockbuster revenue in the forecast. Bristol-Myers has had its troubles, but with the buyouts still coming, the company has a strategy that has been working well.
Read more on ipilimumab from Bloomberg.




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