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W. Scott Harkonen, Wire Fraud, California 2009

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Former InterMune CEO Sentenced for Wire Fraud

San Francisco, CA – W. Scott Harkonen, the former chief executive officer (CEO) of InterMune Inc., was sentenced on Wednesday, September 2009 before U.S. District Court Judge Marilyn Hall Patel for wire fraud relating to the dissemination of false and misleading statements about the results of a clinical trial of InterMune’s drug Actimmune.

Harkonen was ordered to serve three years’ probation, with six months of home confinement. He was also ordered to pay a $20,000 fine and to perform 200 hours of community service.

Harkonen was convicted of wire fraud in September 2009 after a seven-week trial. The evidence presented at trial showed that Harkonen was the CEO of InterMune from February 1998 through June 30, 2003 and a member of InterMune’s board of directors.

Under Harkonen’s direction, InterMune marketed and sold Actimmune to treat the fatal disease idiopathic pulmonary fibrosis (IPF) despite the fact that Actimmune was not approved by the Food and Drug Administration (FDA) as a safe and effective treatment. The cost of Actimmune for one IPF patient for one year was approximately $50,000 and the vast majority of the sales of Actimmune were for the unapproved, off-label use of treating IPF.

Evidence at trial further showed that Harkonen caused InterMune to issue a false and misleading press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF on August 28, 2002. Although the clinical trial had failed, InterMune’s press release falsely stated that the results of the clinical trial established that Actimmune helped IPF patients live longer.

InterMune agreed to enter into a deferred prosecution agreement and to pay nearly $37 million to resolve criminal charges and civil liability in connection with the illegal promotion and marketing of its drug Actimmune in October 2006.

‘The government is firmly committed to holding accountable corporate executives who promote drugs using false or fraudulent information,’ said Acting Deputy Assistant Attorney General for the Office of Consumer Protection Litigation, Maame Ewusi-Mensah Frimpong. ‘Executives like Dr. Harkonen, who—without regard for patient health or safety—engage in criminal conduct on behalf of their companies, will not be permitted to carry out this conduct with impunity.’

This case is being prosecuted by Assistant U.S. Attorney Kyle Waldinger of the Northern District of California and Trial Attorney Allan Gordus of the Office of Consumer Protection Litigation with the U.S. Department of Justice in Washington, D.C.

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