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UPDATE 1-Amgen documents on Enbrel marketing subpoenaed

Thu Jan 17, 2008 1:53pm EST

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(Adds subpoena details, Amgen comment, background, share price)

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NEW YORK, Jan 17 (Reuters) - New Jersey's attorney general said on Thursday she has subpoenaed Amgen Inc (AMGN.O) regarding allegations that the biotechnology company promoted its rheumatoid arthritis and psoriasis drug Enbrel for unapproved uses.

In the subpoena served Monday, Attorney General Anne Milgram is seeking "a comprehensive array of documents and information" concerning the marketing and sale of Enbrel from July 2002 to the present.

The subpoena calls for Amgen to deliver the required materials by Feb. 4.

Amgen spokeswoman Mary Klem confirmed that the company had received the subpoena and said it intends to "cooperate fully with the New Jersey attorney general in this investigation."

"Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency," Klem said in a statement.

While doctors are free to prescribe medicines as they see fit -- including for so-called off-label use -- drug companies are allowed to promote their products only for uses that have been approved by the U.S. Food and Drug Administration.

Enbrel, a $3 billion-a-year medicine, was originally approved to treat rheumatoid arthritis and later received FDA approvals for psoriatic arthritis and moderate to severe cases of the skin condition psoriasis.

In addition to allegations of off-label promotion, New Jersey is looking into whether Amgen violated medical privacy laws for the purpose of direct marketing, the AG's office said in a news release.

The subpoena follows news last week that two former Amgen salespeople were suing the company for lost wages and other compensation after allegedly refusing to participate in improper Enbrel promotion.

The two former employees, one of whom is from New Jersey, allege that Amgen encouraged its sales force to illegally access patient records to induce insurance carriers to pay for the drug, which has an annual cost of about $16,000 for a psoriasis patient.

The suit also alleges that salespeople were encouraged to promote Enbrel for cases of psoriasis that were less severe than those for which it is approved.

Amgen has said it believes the lawsuit is without merit.

Investors appeared to shrug off news of the subpoena. Amgen shares were up 35 cents to $47.84 on Nasdaq. (Reporting by Bill Berkrot; Editing by Jeffrey Benkoe and John Wallace)



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