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AstraZeneca Goes to the Well One Last Time


Big Pharma is squeezing everything it can out of blockbuster statins.

Blockbuster statins may be due for death-by-patent cliff in the next few years, but Big Pharma hasn't finished squeezing all the profits it can out of the cholesterol-lowering, money-making machines.

AstraZeneca (AZN) announced Tuesday that the FDA has approved its blockbuster statin Crestor for a whole new patient population that doesn't have high cholesterol. The drug will now also be prescribed to men over the age of 50 and women over 60 years old who have an increased risk of heart disease. Leerink Swann analyst Seamus Fernandez estimates that this will increase the number of Crestor prescriptions by another 5 million to 7 million people, adding 24% to Crestor's year-over-year revenues.

The expanded label decision was based on information from a study that was published 14 months ago in the New England Journal of Medicine called JUPITER, or Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin. While there may have been some qualms about the company-sponsored study and some conflicts of interest among investigators involved in the study, the outcome of JUPITER was undeniable -- Crestor lowered the risk of heart disease and stroke in patients who were at higher risk due to family history, smoking, or hypertension.

The results of JUPITER showed that for older men and women (over 50 and 60, respectively) the risk of heart attack was reduced by 54%, the risk of stroke was cut by 48%, and the total risk of death dropped by 20% -- those numbers are extremely significant.

Crestor is already one of the best-selling drugs in the world with revenues of $4.5 billion in 2009, up 25% from $3.6 billion in 2008, but the blockbuster will lose patent protection in 2016. The company is already fighting plenty of court battles trying to defend that 2016 date as generic companies like Israel's Teva Pharmaceuticals (TEVA) try to get the patent expiration pushed up.

While the Crestor label expansion is a win for the Anglo-Swedish drugmaker, it does have a looming dark cloud -- Pfizer's (PFE) Lipitor is set to lose patent protection in 2011. AstraZeneca won't reap all of the benefits that the JUPITER study could have provided; generic drugmakers who venture into Lipitor territory will also see some of those dollars. A MEDACorp study of more than 100 physicians conducted in January 2009 (just after the JUPITER results were published) showed that doctors were not only more likely to prescribe Crestor to patients, but all statins -- iffy news for AstraZeneca; great news for Pfizer (at least for now) and, most importantly, for patients.

Statins have been one of the most revolutionary classes of drugs of our lifetime. Their affect on people's health has grown leaps and bounds -- IMS Health estimates that the market doubled from 2000 to 2006 and they were the top-selling drugs every year from 1999 to 2008. Yet, despite the power of the statin, these drugs have lost some of their market value -- particularly with the introduction of generics for Merck's (MRK) Zocor.

With the passing of Lipitor into the generic void and eventually Crestor, it's likely that we've seen the last of the great blockbuster drug age; an age of drugs that could be prescribed to huge swaths of patients for multiple maladies. The drug industry is preparing for the death of the blockbuster by bulking up on biotechs as the new age of personal medicine dawns. (See, Pharma's Next Big Thing: Personalized Medicine)

Kamal Puri | Technology Manager | Minyanville Media, Inc.

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