AstraZeneca: A Lesson in How to Shoot Yourself in the Foot? - The Source - WSJ

• By Sten Stovall

There must have been an enormous groan emitted from AstraZeneca’s London Headquarters last month when results came in from a study showing the company’s most important product, anti-cholesterol drug Crestor, failed to differentiate itself significantly from its top rival, Pfizer Inc.’s Lipitor.

Lipitor’s U.S. patent expires next month. So, cheap copies of Lipitor, a $12 billion-a-year seller, are expected to hit the key U.S. market at the end of November and in Europe next year, making competition in an already tough market heat up sharply—a prospect that deeply worries AstraZeneca.

The British company took a gamble by launching and funding a head-to-head study between the two powerful cholesterol drugs, hoping to make Crestor stand out from the crowd once Lipitor goes generic.

But the gamble seems to have backfired.

Saturn’s imaging tests showed that although patients on Crestor had a lower rate of artery-clogging plaque than those on Lipitor, the difference in that main goal wasn’t statistically significant. Crestor did show a significant improvement over Lipitor in a secondary endpoint, however.

With patents on many of its other drugs having expired or about to expire, AstraZeneca needs Crestor to keep growing strongly if it is to achieve its goal of $28-34 billion in annual group sales between 2010 and 2014.

As Bernstein analyst Tim Anderson said earlier this week: “If Saturn doesn’t show a clear benefit in favor of Crestor, payers could push back even harder against usage of the drug downstream of Lipitor generics.”

The Saturn study, initiated by the U.K. group, doesn’t seem to offer AstraZeneca much ammunition for that battle.

The company says views on Crestor’s efficacy versus Lipitor should not be based solely on this trial.

“Conclusions on the efficacy of Crestor should not be based on the Saturn study alone but on the wealth of data that exists on the safety and efficacy profile of the treatment,” a spokeswoman said.

“Crestor has been shown to be the most effective statin in terms of lowering (“bad”) LDL cholesterol and significantly raising (“good”) HDL cholesterol, particularly at higher doses in multiple randomised controlled trials without compromising tolerability,” she said.

Analysts say the jury on Crestor’s relative merits “may remain out” until full results from the Saturn trial are presented at the annual meeting of the American Heart Association Nov. 15.

via blogs.wsj.com

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