= By Peter Loftus = Of DOW JONES NEWSWIRES =
The U.S. government has asked Johnson & Johnson (JNJ) for more inf= ormation about the sales and marketing of the antipsychotics Risperdal a= nd 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 additio= nal information. The company didn't disclose more details; a J&= J spokesman declined immediate comment. J&J has said it's coope= rating with government requests for documents and witnesses related to R= isperdal.
J&J hasn't disclosed the exact nature of the probes, but gove= rnment investigations of competing antipsychotics including Eli Lilly &a= mp; Co.'s (LLY) Zyprexa have centered on allegations of promoting t= he drugs for uses not approved by the U.S. Food and Drug Administration.= The marketing of antispychotics has drawn government scrutiny because t= hey comprise a big part of the prescription-drug costs for state Medicai= d programs, which serve the poor.
Last year Lilly paid more than $1.4 billion and pleaded guilty to a cr= iminal charge to settle government probes related to Zyprexa, and AstraZ= eneca 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&a= mp;J in January, alleging the company paid millions of dollars in kickba= cks to Omnicare Inc. (OCR), which provides pharmacy-services to nursing = homes. The government alleged J&J paid the kickbacks to induce Omnic= are to purchase and recommend J&J drugs including Risperdal for use = in nursing homes. J&J said it believes its conduct was lawful and ap= propriate.
J&J previously disclosed government interest in Risperdal, which w= as once its best-selling drug, as far back as 2004. The Office of the In= spector General of the U.S. Office of Personnel Management issued a subp= oena to J&J that year seeking documents related to sales and marketi= ng 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 d= ocuments related to Risperdal. J&J also said it has received subpoen= as seeking testimony from various witnesses before a grand jury.
The oral formulation of Risperdal lost patent protection in 2008, expo= sing it to generic competition, which has caused significant sales decli= nes. Risperdal pills had sales of $3.4 billion in 2007, the last full ye= ar it had market exclusivity. An injectable formulation of Risperdal rem= ains 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; peter.loftus@dowj= ones.com
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