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MARCH 1, 2010, 6:12 P.M. ET

US Seeks More Information About J&J Antipsychotic Marketing

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By Peter Loftus
Of DOW JONES NEWSWIRES

The U.S. government has asked Johnson & Johnson (JNJ) for more information about the sales and marketing of the antipsychotics Risperdal and Invega, continuing a years-long probe.

J&J disclosed in a regulatory filing Monday the government served "civil investigative demands" to J&J in February seeking the additional information. The company didn't disclose more details; a J&J spokesman declined immediate comment. J&J has said it's cooperating with government requests for documents and witnesses related to Risperdal.

J&J hasn't disclosed the exact nature of the probes, but government investigations of competing antipsychotics including Eli Lilly & Co.'s (LLY) Zyprexa have centered on allegations of promoting the drugs for uses not approved by the U.S. Food and Drug Administration. The marketing of antispychotics has drawn government scrutiny because they comprise a big part of the prescription-drug costs for state Medicaid programs, which serve the poor.

Last year Lilly paid more than $1.4 billion and pleaded guilty to a criminal charge to settle government probes related to Zyprexa, and AstraZeneca PLC (AZN) is close to settling a government probe of its marketing of antipsychotic Seroquel for more than $500 million.

In a separate case, the U.S. Attorney's Office in Boston sued J&J in January, alleging the company paid millions of dollars in kickbacks to Omnicare Inc. (OCR), which provides pharmacy-services to nursing homes. The government alleged J&J paid the kickbacks to induce Omnicare to purchase and recommend J&J drugs including Risperdal for use in nursing homes. J&J said it believes its conduct was lawful and appropriate.

J&J previously disclosed government interest in Risperdal, which was once its best-selling drug, as far back as 2004. The Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena to J&J that year seeking documents related to sales and marketing of Risperdal, including any payments to physicians. Also, the office sought documents related to the clinical trials for Risperdal.

In 2005, the U.S. Attorney's Office in Philadelphia also sought documents related to Risperdal. J&J also said it has received subpoenas seeking testimony from various witnesses before a grand jury.

The oral formulation of Risperdal lost patent protection in 2008, exposing it to generic competition, which has caused significant sales declines. Risperdal pills had sales of $3.4 billion in 2007, the last full year it had market exclusivity. An injectable formulation of Risperdal remains patent-protected and last year had sales of $1.4 billion.

J&J's follow-up to Risperdal, Invega, was approved by the FDA in 2006. It generated $393 million in sales for 2009.

J&J shares closed up 39 cents to $63.39 Monday.

-By Peter Loftus, Dow Jones Newswires; 215-656-8289; [email-masked]

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