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Glaxo to Pay $3 Billion to Settle U.S. Cases on Sales, Marketing, Avandia

Original source:

Phil Serafino and Makiko Kitamura
Nov. 3, 2011

GlaxoSmithKline Plc (GSK) agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.

Negotiations over the terms will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.

The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.

“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”

Glaxo’s American depositary receipts, each representing two ordinary shares, rose $1.19, or 2.8 percent, to $44.46 at 2:55 p.m. in New York Stock Exchange composite trading. The company’S shares rose 1.7 percent to close at 1,378 pence in London.

Pfizer Settlement

The Glaxo settlement would trump the $2.3 billion Pfizer Inc. paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. (LLY) paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.

Abbott Laboratories agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said last month.

“Litigation is an ever-present business risk in the pharmaceuticals industry,” Mark Purcell, a Barclays Capital analyst, wrote in a note to investors today.

The proposed $3 billion settlement is “manageable,” Fitch Ratings said today in a statement. “It should help remove some uncertainty about the group’s finances without putting significant pressure on its ‘A+’ credit rating.”

Avandia, Paxil

Glaxo said in January it was taking the $3.5 billion charge to cover expenses linked to investigations and suits over its withdrawn Avandia diabetes drug and other medications. The reserve brought to $6.4 billion the amount the drugmaker has set aside for legal costs tied to Avandia and the other medicines.

For example, the company has paid more than $1 billion to settle patient lawsuits alleging its Paxil antidepressant caused birth defects in some users, people familiar with the accords said in July 2010. The settlements averaged about $1 million per claim, the people said. The company is continuing to settle cases, they added.

Glaxo also has paid more than $700 million to resolve patient lawsuits alleging Avandia caused heart attacks and strokes, according to people familiar with the accords. Settlements in those cases averaged around $50,000, the people said.

Colorado Probe

Many of those cases had been consolidated before a federal judge in Philadelphia as part of a multi-district litigation for pre-trial exchanges of information.

Federal prosecutors began an investigation in Colorado in 2004, later taken over by the U.S. attorney in Massachusetts, into whether Glaxo promoted drugs for unapproved uses, and into ways Glaxo potentially influenced doctors. The probe concerns nine of the company’s best-selling products from 1997 to 2004, including the Advair lung treatment, Glaxo said in its annual report.

Today’s settlement also covers a U.S. Justice Department probe of Glaxo and a Medicaid rebate program, and a Justice Department investigation into the development and marketing of Avandia, the company said.

Drugmakers are required to give rebates to Medicaid, the government health insurance program for the poor. The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.

‘High Standards’

Regulators said last year Avandia would be withdrawn from the market in Europe and sales would be limited in the U.S. because of an increased risk of heart attacks.

“This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Chief Executive Officer Andrew Witty said in the statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”

Earlier this year, Glaxo changed incentive compensation programs for U.S. sales representatives. The company has eliminated the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance of the representative’s business unit.

Glaxo still faces probes involving the United Nations oil- for-food program, and HIV product sales and marketing in the U.S., JPMorgan Chase & Co. analysts wrote in a note to investors today.

‘Speed Bumps’

The company agreed to pay more than $250 million to resolve about 5,500 claims related to Avandia to avoid the first trials over claims it can kill users, two people familiar with the accords said in February. Glaxo declined to comment on those figures today.

“These settlements are just speed bumps to drug companies, a small blip in their global revenue,” said Kevin Outterson, a professor of health law at Boston University and editor-in-chief of the Journal of Law, Medicine & Ethics.

The legal provision, announced in January, led to a loss for Glaxo in the fourth quarter of 2010. Less than three weeks after the provision was disclosed, the company said it would begin a share repurchase for the first time since 2008 to enhance investor returns.

The consolidated Avandia case is In RE Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).

To contact the reporters on this story: Phil Serafino in Paris at; Makiko Kitamura in London at

To contact the editor responsible for this story: Phil Serafino at