Astra cautious on FDA view of Brilinta

AstraZeneca Chief Executive David Brennan speaking in Boston, May 6, 2008.

NEW YORK (Reuters) - AstraZeneca Plc (AZN.L) Chief Executive David Brennan was cautious in assessing how U.S. health regulators might rule on the company's heart drug Brilinta, seen as the most crucial development for it this year.

The Food and Drug Administration is expected to make an approval decision on the drug, considered the company's most important new product, by July 20.

"It's difficult to predict what the FDA is going to say about the product overall," Brennan told the Reuters Health Summit in New York on Monday.

Brilinta is already approved in more than 30 countries, but its prospects in the key U.S. market are under a cloud because American patients taking it in a pivotal clinical trial appeared to do worse than those on Plavix.

Astra's drug is viewed as a potential multibillion-dollar seller that would compete with Sanofi SA (SASY.PA) and Bristol-Myers Squibb Co's (BMY.N) Plavix, but only if doctors are convinced it will work better. Plavix, the world's second biggest selling drug, brings in $9 billion a year.

There has been speculation that the FDA will ask for more evidence of the drug's effectiveness in U.S. patients before approving it.

"Obviously, if we're asked to do stuff, then we will figure out how to do it -- including trials if that's what we're asked about. But we don't have any indication that's the case.

"We are still confident in the NDA (new drug application) submission," Brennan said.

"We did the definitive trial," he said.

"We're going to continue working with the FDA on the basis that the overall outcome of the clinical trial with over 18,000 patients showed a significant reduction in the overall morbidity and mortality. The death rates were reduced when compared to clopidogrel," he said, using the generic name for Plavix, which is set to lose U.S. patent protection next year.

Brennan expects sales of the blood thinner to begin to ramp up in Europe in the second half of this year "unless it takes longer to get some of these pricing approvals in Europe than we anticipated."

Meanwhile, Astra's current top seller -- the cholesterol fighter Crestor -- faces a tough time beginning in November, when rival Pfizer Inc (PFE.N) drug Lipitor loses patent protection.

Insurance plans and pharmacy benefit managers are expected to try to get many patients to switch from higher-priced statins, including Crestor, to cheaper generic Lipitor.

U.S. sales of Crestor disappointed some analysts in the first quarter, but Brennan sees them improving.

"We would expect Crestor to do better in the second quarter," he said.

Global Crestor sales are on pace to exceed $6 billion this year.

"It's growing faster than the statin market worldwide and in every major market where we compete," Brennan said. "It's a key driver for us. It will continue to be."

The company is currently conducting a head-to-head study against Lipitor in which AstraZeneca hopes to demonstrate that its drug is superior in slowing or reducing buildup of artery-clogging plaque than the Pfizer drug.

Brennan also said there has been "a lot of interest" in the drugmaker's dental and medical technology unit, Astra Tech, which the company is considering selling. Analysts believe the unit could bring $2 billion in a sale.

"We're going to have to wait and see what the deals look like before deciding whether to sell," Brennan said, noting that the value of any deal would have to exceed what the company believes it could realize by continuing to run the business.

Following a slowdown during the economic recession, Brennan said, "the dental implant business has come back strongly."

AstraZeneca is expected to see overall sales slide over the next five years as it loses patent protection on its multibillion-dollar drugs Nexium for heartburn and Seroquel for schizophrenia.

Even if Brilinta lives up to expectations, many analysts believe Astra will still need to add additional products through deals or acquisitions to make up for sales lost to generics.

Brennan reiterated that he was not interested in large-scale acquisitions, but would look for smaller deals to help fill out the company's product lineup as other drugs begin to face more intense generic competition.

"We're looking to improve the quality and strength of our pipeline and get a few more products onto the market. We're not looking to do big, big deals."

(Reporting by Bill Berkrot and Ben Hirschler; Editing by John Wallace and Gerald E. McCormick)