Jude Concepcion, the senior legal director at Eisai Inc., took a pugnacious stance when battling pharmaceutical fraud charges; he helped his company settle an off-label marketing case for $11 million without a requirement to overhaul company compliance. The case about improper marketing of the company’s anti-epileptic drug Zonegran settled in December 2010 with the drug’s original owner, Elan Corp., footing the bulk of the $214.5 million bill.
Concepcion, 38, knew that Japanese parent company Eisai Co. Ltd. was inheriting a troubled drug marketing strategy when it bought the drug from Elan in March 2004. But Eisai wanted to make inroads into the U.S. anti-epileptic market, so Concepcion led a quick revamp of the drug’s new promotional materials, along with a retraining of the sales force. It wasn’t enough to avoid a January 2006 subpoena, but avoiding a corporate-integrity agreement was a coup. Eisai insisted it would litigate instead of signing such an agreement, Concepcion said. “We were very aggressive back towards the government.”
Concepcion also coordinated two lawsuits to stop generic launches against key company drugs. In March 2008, a New Jersey federal judge issued a preliminary injunction against Teva Pharmaceuticals USA Inc. for the company’s dementia-treatment drug Aricept. In July of that year, the Federal Circuit upheld an infringement ruling against Dr. Reddy’s Laboratories Ltd. over Eisai’s ulcer and heartburn drug Aciphex.
A graduate of Yeshiva University Benjamin N. Cardozo School of Law with a science background, Concepcion was recruited by Eisai in 2002. “I got to grow with the company as the company was growing,” he said. “I’ve had so many different responsibilities.” — Sheri Qualters