4 Potential Blockbuster Drugs Awaiting Launch By AMY REEVES, INVESTOR'S BUSINESS DAILYPosted 12/05/2013 06:21 PM ET Although many say the drug industry is entering the "post-blockbuster era" as mega-sellers such as Lipitor lose their patents, there are drugs in the pipeline expected to pass the traditional blockbuster benchmark of $1 billion in global annual sales.Here's a preview of four of them, expected to launch in the next 12 months, that have attracted much interest from Wall Street.
• Sovaldi: Gilead Sciences' (GILD) hepatitis C treatment, formerly known as sofosbuvir, is one of the most anticipated new drugs in the industry in quite some time. Everyone and his mother expect the FDA to approve it by its Sunday deadline, thanks to the strong safety and efficacy data produced in its clinical trials.Few drugs are "blockbusters," signifying annual sales of at least $1 billion, but a number of products near final approval could join that club.... Few drugs are "blockbusters," signifying annual sales of at least $1 billion, but a number of products near final approval could join that club.... View Enlarged ImageAnalysts are modeling an already-blockbuster $1.7 billion in sales next year, climbing to $8 billion in 2018, making it one of the best-selling drugs in the world.Expectations are so high because Sovaldi promises substantial improvement on existing treatments for a serious disease. It's both more effective and has fewer side effects than the standard regimen of pegylated interferon, and it can be swallowed rather than injected.The only live question at this point is where Gilead will price the drug. ISI Group analyst Mark Schoenebaum's informal survey of buy-side analysts last month found an average estimate of $85,000 for 12 weeks of treatment, but sell-side estimates have been running as high as $100,000. The price depends partly on how the FDA chooses to label the drug, which remains to be seen.
• Nivolumab: Bristol-Myers Squibb (BMY) has been taking a go-big-or-go-home approach with this drug, conducting some 25 clinical trials in various types of cancers.Most of those trials won't be complete for a while yet, but Wall Street is holding out hope that its so-far excellent data on squamous non-small-cell lung cancer — one of the deadliest and most stubborn forms of the disease — will support an FDA filing in early 2014, followed by approval late in the year.The FDA has granted fast-track designation for that label, as well as for advanced melanoma and kidney carcinoma. Current consensus is modeling $57 million in sales next year, ballooning to $4.7 billion by 2020. Since nivolumab will likely be combined with another Bristol drug, Yervoy, joint sales could bring the company $6.9 billion a year, according to Schoenebaum's survey.
New Class Of DrugsNivolumab is in a new class of drugs called PD-1 inhibitors, which have attracted much interest in the industry.