My mother always warned me never to start a column with a reference to management consultants. Sorry, Mom. Cover your eyes. But anyone else with personal health or personal finance interest in the latest cholesterol-fighting drugs, read on.
Two years ago, three McKinseyites published a study about forecasts for drug sales. The upshot: To predict future blockbusters, you might as well start throwing darts.
Ladies and gentlemen, get your darts ready. Today and tomorrow a panel of experts who advise the FDA will convene in a hotel ballroom outside Washington, DC, to jawbone about two anti-cholesterol drugs, and they are largely expected to recommend FDA approval, which would come in July and August.
The drugs, evolocumab (Repatha) from Amgen (NASDAQ: [[ticker:AMGN]]) and alirocumab (Praluent) from Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) and Sanofi (NYSE: [[ticker:SNY]]), could also reach blockbuster status—$1 billion in annual sales—in fast fashion. That’s a lot of cart-before-horsing, but the two drugs’ safety and efficacy record in clinical trials does seem to make approval a good bet.
The big sales, though? For context, here from pharma data provider IMS Health (NYSE: [[ticker:IMS]]) are the top drug launches since 2010, based on their first 12 months of U.S. sales.
TOP DRUG LAUNCHES, 2010-PRESENT
(source: IMS Health)
| Brand Name | Disease | Company | Date of Launch |
First-Year Revenue ($) |
|---|---|---|---|---|
| Sovaldi | HCV | Gilead Sciences | 12/2013 | 7.6 B |
| Harvoni | HCV | Gilead Sciences | 10/2014 | 5.4 B |
| Olysio | HCV | Johnson & Johnson | 12/2013 | 1.9 B |
| Tecfidera | MS | Biogen | 4/2013 | 1.6 B |
| Incivek | HCV | Vertex Pharmaceuticals | 5/2011 | 1.4 B |
Just to show how quickly fate can change, telaprevir (Incivek) was off the market in three years, and simprevir (Olysio), after a booming 2014, was singled out last month by owner J&J as having “negative impact” on the company’s worldwide growth in the first quarter of 2015. Both those beatings came at the hands of the top two drugs on the launch chart, Gilead’s sofosbuvir (Sovaldi) and combination offering Harvoni, which promised cures and were priced accordingly; the hepatitis C world has been an extreme theme-park ride for all involved.
A mercurial market could await the drugs in discussion this week, too. They are the first two entrants from the next generation of cholesterol-lowering treatments that work by blocking a protein discovered 12 years ago called PCSK9. (It stands for proprotein convertase subtilisin/kexin Type 9; you’ll be quizzed on this tomorrow.)
Statins such as atorvastatin (Lipitor) have been the most lucrative drugs of all time, and there are a lot of people out there who aren’t helped by them (more on this in a minute). So why wouldn’t these two new drugs bust out of the gate? Let’s ask the McKinsey consultants, who pored over drug forecasts and launches from 2002 to 2011: “Most consensus forecasts were wrong, often substantially… and accuracy remained an issue even several years post-launch.”
“Furthermore,” they wrote, “a significant number of consensus forecasts were overly optimistic by more than 160 percent of the actual peak revenues of the product.”
Analysts at Leerink Partners late last year said the market for PCSK9-inhibitors for cardiovascular disease could reach nearly $11 billion at its peak, with alirocumab and evolocumab, the two drugs in this week’s spotlight, each nabbing 40 percent.
The stakes are high enough that Regeneron and Sanofi paid
