AstraZeneca's Crestor fails to best Lipitor in study

AstraZeneca ($AZN) just lost a potential marketing edge for Crestor. In trial results announced today, the statin drug failed to best Lipitor at clearing clogged arteries, at least in a statistically significant way. And it's statistical significance that makes the difference, sales-wise; without it, the company can't tout Crestor as superior to the Pfizer ($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 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.

- read the release from AZ
- see the Bloomberg coverage
- get the story from Reuters