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By Jason Douglas
Of DOW JONES NEWSWIRES
LONDON -(Dow Jones)- U.K. drug maker Shire PLC (SHP.LN) said Friday it has been subpoenaed by the U.S. authorities over the marketing of three drugs, as it reported a swing into profit for the third quarter.
Shire said, as part of its third-quarter results, that it received a subpoena Sept. 23 from the U.S. Department of Health and Human Services and the U.S. Attorney for the Eastern District of Pennsylvania, asking it for documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, three drugs for attention deficit hyperactivity disorder, or ADHD.
Shire Chief Executive Angus Russell told reporters Shire is cooperating and responding to the subpoena.
He said such requests for information are increasingly routine for drug makers and there's no evidence Shire has done anything wrong.
"We are a very regulated industry and it is becoming normal practice that from time to time companies of our size or bigger have inquiries from the government," Russell said.
Drug makers' sales and marketing practices have come under increasing scrutiny, especially in the U.S., where charges have been brought against firms accused of illegally marketing drugs for uses for which they don't have Food and Drug Administration approval.
Pfizer Inc. (PFE) paid $2.3 billion in September to settle charges it improperly promoted painkiller Bextra and other medicines.
Thursday, the U.K.'s AstraZeneca PLC (AZN.LN) said it agreed to settle a U.S. investigation into its marketing of schizophrenia drug Seroquel for $520 million.
Basingstoke, England-based Shire said Friday that third-quarter net profit was $59.6 million, compared with a loss of $34.9 million a year earlier. The year-earlier figure was restated to include a $73 million interest and tax expense relating to settling litigation surrounding an acquisition.
Revenue declined 15% to $602.5 million from $712.5 million, hurt by a 74% year-on-year fall in sales of Adderall XR, which is now losing ground to cut-price generic copies.
Sales of Vyvanse rose 34% to $129 million, however. Russell said a recently linked partnership with GlaxoSmithKline PLC (GSK.LN) to sell Vyvanse in the U.S. should help future sales, as the two companies intend to market it to some 70,000 doctors, whereas Shire was targeting only 40,000.
Intuniv, another hyperactivity medicine, recently won FDA approval and will go on sale next week, Shire said.
Also Friday, Shire said it has the capacity to make enough of an as-yet unapproved drug for a rare disease for between 300 and 600 U.S. patients, amid a shortage of the only other medicine available.
Shire's velaglucerase alfa, known as vela, has been made available to sufferers of Gaucher disease ahead of formal approval in the U.S. because of shortages of Genzyme Corp.'s (GENZ) Cerezyme caused by manufacturing problems.
Russell said patients are already switching to vela, although he declined to say precisely how many. There are roughly 4,000 Gaucher patients affected by the shortages and the number using vela is rising daily, he said. Shire expects to boost its capacity so it can treat several hundred more patients next year.
The FDA is also reviewing Replagal, a Shire drug for Fabry disease, a similar genetic condition. Both Fabry and Gaucher are characterized by an inability to break down types of fats that subsequently build up in blood vessels, tissues and organs.
Supplies of Fabrazyme, Genzyme's drug for Fabry disease, have also been affected by its production woes.
At 1401 GMT, shares in Shire were up 48 pence, or 4.7%, at 1,072 pence, making it the biggest riser in a 0.1% lower FTSE 100 index.
Company Web site: www.shire.com
-By Jason Douglas, Dow Jones Newswires; 44-20-7842-9272; jason.douglas@dowjones.com