AstraZeneca says Justice probe is over

Posted: August 21, 2014

Drugmaker AstraZeneca said Tuesday that the U.S. Justice Department had notified the British-based company that it was no longer investigating allegations of manipulation of clinical testing data for a key drug that the company hopes will eventually generate billions of dollars in revenue.

The drug, Brilinta, is a blood thinner prescribed for some of those with clogged arteries in hope of avoiding heart attacks. AstraZeneca chief executive officer Pascal Soriot used the revenue possibilities from the drug to argue for declining three takeover offers from Pfizer Inc.

"As one of AstraZeneca's growth platforms, we remain committed to delivering the full potential of this important medicine," Soriot said in a statement Tuesday.

Like some other big pharmaceutical companies, AstraZeneca has had big changes in its workforce in recent years. It has about 2,600 employees in Delaware, with the North American commercial headquarters in Wilmington and a manufacturing plant in Newark. About 575 employees work in Pennsylvania, with units in Fort Washington and Northeast Philadelphia. Sales reps work in both states and New Jersey.

The FDA approved Brilinta in 2011 after testing showed that when used with certain doses of aspirin, better results were achieved than with Plavix, a blood thinner used by millions and the generator of billions in revenue for Sanofi. But in a series of papers, critics contended AstraZeneca manipulated data from a trial called PLATO that was submitted to the FDA. AstraZeneca said in a late 2013 SEC filing that the Justice Department was investigating.

Bernstein Research analyst Tim Anderson said in a note to clients at the time that he had projected Brilinta would have $1.3 billion in annual sales by 2018.

"It's difficult to quantify, but the investigation did have an impact in the early days," AstraZeneca's Paul Spittle, a Wilmington-based vice president, said Tuesday.

Spittle's staff tried to reassure doctors and other providers that the clinical trial data were sound and the drug was safe when used properly.

Second quarter sales improved 77 percent to $117 million compared with the same period in 2013. That will make AstraZeneca more appealing to Pfizer, if it makes another try.

"Your guess is as good as mine on that," Spittle said, "but we are very pleased with this good news for AstraZeneca."

Justice Department spokeswoman Nicole Navas said that as a matter of policy the department does not comment on investigations.


dsell@phillynews.com

215-854-4506 @phillypharma

www.inquirer.com/phillypharma

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