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Feb 04, 2012 05:47AM GMT
     
 
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INTERVIEW-UPDATE 1-Astra CEO shrugs off Crestor doubters

By Reuters  |  General News  |  Feb 11, 2010 12:38PM GMT
 
 

* New label to drive awareness, use of drug in coming year

* CEO confident on patent after very thorough due diligence (Adds quotes, comment on generic Lipitor)

By Ben Hirschler

LONDON, Feb 11 (Reuters) - AstraZeneca expects use of its blockbuster heart drug Crestor to grow substantially over the next 12 months on the back of an expanded label granted by the U.S. Food and Drug Administration this week.

Some analysts have argued much of the sales benefit has already been seen, since results from the so-called Jupiter trial supporting the new label have been known since late 2008.

But Chief Executive David Brennan told Reuters on Thursday this ignored the sizeable upside the company would now enjoy from being able to promote the drug's new use to all doctors.

"One year from today there will be significantly more awareness and trial of the product as a result of the Jupiter data being put on the label," he said on the sidelines of an Economist pharmaceuticals conference.

While many cardiologists are already aware of Jupiter, which showed Crestor can prevent heart disease in people with normal cholesterol but other heart risks, Brennan said the message had not yet got out widely among primary care doctors.

Crestor is the only cholesterol-lowering statin drug approved for such use, and AstraZeneca hopes this will help it maintain the strategic high ground, despite fierce competition.

This includes the looming arrival of generic copies of Pfizer's best-selling Lipitor drug, which loses patent protection in November 2011.

Brennan acknowledged generic Lipitor would be a challenge.

"There will be more utilisation of generics when Lipitor goes generic, but you will still have Crestor. Doctors want another product they can go to -- and it's better," he said.

PRICING PRESSURES

AstraZeneca already has experience of a similar situation with its heartburn drug Nexium, which held on to sizeable market share despite the arrival of generics in the same drug class, although maintaining Nexium volumes required price cuts.

Asked whether the same thing would happen with Crestor, Brennan said:

"I imagine there will be more pricing pressure. I don't know if it will be Nexium-style because cardiovascular disease is viewed differently than acid disorders by payers."

AstraZeneca's sales of Crestor are forecast to reach $6.5 billion in 2013, up from $4.5 billion in 2009, according to consensus estimates from Thomson Pharma, making it the company's most important sales driver.

But estimates vary widely, with some bullish analysts forecasting sales of up to $8 billion, while sceptics have far lower numbers because of the challenge from generic Lipitor.

The other big threat to Crestor is a U.S. court case starting on Feb. 22 over the main patent protecting the medicine, which AstraZeneca licensed from Japan's Shionogi in 1998. Brennan reiterated his confidence in AstraZeneca's legal case.

"Number one, we have confidence in our intellectual property. Number two, this product was licensed in and there was very, very thorough due diligence done at the time," he said.

"There was a recognition that potential issues existed that we're being challenged on and the position is the same today as it was then, which is we felt we could manage it. There is always risk associated with a trial but we've got a pretty sound story to tell."

A verdict in the case is expected before the end of July, when Judge Joseph Farnan is due to retire.

The main U.S. patent protecting the medicine until 2016 is being challenged by a group of generics manufacturers including Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva. (Editing by Rupert Winchester)

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