AstraZeneca (NYS: AZN) just lost a potential marketing edge for Crestor. In trial results announced today, the statin drug failed to best Lipitor at clearing clogged arteries, at least in a statistically significant way. And it's statistical significance that makes the difference, sales-wise; without it, the company can't tout Crestor as superior to the Pfizer (NYS: PFE) drug.
And that's really important, given Lipitor goes off patent later this year. Crestor and its brand-name price will be competing against cheaper Lipitor generics. Crestor is generally regarded as the statin most effective in harder-to-treat patients, analysts say. But garden-variety patients who might otherwise have used Crestor might turn to Lipitor instead, especially as budget-conscious payers raise co-pays.
The study, dubbed Saturn, was a calculated risk on AstraZeneca's part when it launched several years ago. Drugmakers don't often do head-to-head trials with competing drugs, at least not voluntarily. But AstraZeneca figured Crestor, which has a strong effect on bad cholesterol, had a good chance of topping Lipitor at dealing with arterial plaque. If Crestor could prove better, then it would have that superiority claim to help weather an onslaught of low-priced Lipitor knockoffs.
AstraZeneca garnered $5.6 billion from Crestor sales last year, so pharma-watchers have been eagerly awaiting the Saturn results. The company's stock dropped on the news, and analysts began a lament. Matrix's Navid Malik downgraded the stock to "reduce" and said he's expecting Crestor sales to suffer. "The failure ... to reach statistical significance calls into question the rationale for use of the 40-mg dose altogether," Malik said in a statement.
Sanford Bernstein's Tim Anderson lowered his 2015 sales estimate by 5%, to $6.5 billion. But MF Global's Justin Smith said Crestor will hold its own against generic Lipitor because of its efficacy in hard-to-treat patients. We'll hear more soon; full data from Saturn is due at the American Heart Association meeting Nov. 15.
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