Allergan: Agreement with Justice on the Botox
September 2, 2010 – 4:52 pmThis legal battle had started in the early 2000s. To close the case, Allergan, the U.S. manufacturer of injectable wrinkle treatment Botox, has decided to use extreme measures. The California group said Wednesday it agreed to pay 600 million dollars (467 million euros) to end an investigation by federal authorities on the conditions of marketing and promotion of its star treatment.
"Allergan has agreed to plead guilty to some facts concerning the years 2000 to 2005," the group said in a statement. During this period, the lab admits marketed Botox, botulinum toxin, which allows with its crippling effects to erase facial wrinkles, such that it has been used to treat conditions such as migraine and chronic pain.But the product has not received approval from the Food and Drug Administration (FDA), the American health authority, to treat these disorders.
A special charge of 610 to 615 million dollars
Facts for which the laboratory will pay 375 million dollars in U.S. government, plus 225 million to settle civil complaints. The settlement announced Wednesday will result in the group accounts by an exceptional charge of 610 total $ 615 million, says he. Allergan, however, denies having had intentionally "misleading and deceptive conduct" in the promotion of Botox.
"This agreement is in the best interest of our shareholders, since it solves all the issues that were problematic in the investigation, we avoided significant costs of litigation," commented Executive Vice President of Allergan, Douglas Ingram , quoted in the press release.This epilogue "allows us to devote our time and resources on developing new treatments for patients and the medical community," he adds.
Tony West, Deputy Attorney General U.S. Department of Justice, welcomed the resolution of this conflict in an open letter published on the ministry website. "When allegations of fraud facing our public health programs, these are the health costs of all of us who climb," he says.
The ambitions of Botox
This page legal tour, Allergan has always provided its ambitions for Botox. The Food and Drug Administration (FDA) approved last March the use of Botox for the treatment of some stiffness in adults, said the group in its statement.
Allergan has also filed an application for approval of its drug for the treatment of chronic migraine and is awaiting a decision on this issue before the end of the year. In the United Kingdom, the laboratory has obtained such authorization. A world premiere.
Finally, Botox has also been approved in 70 countries for the treatment of symptoms related to cerebral palsy, but still not the United States. Allergan said it was in talks with the FDA on this issue. Meanwhile, Botox is a successful product. In 2009, its turnover reached nearly $ 1.28 billion, or nearly 30% of total revenues Allergan.
At the NYSE, the action Allergan shares closed up 3.03% Wednesday night at 63.28 dollars.
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