Sales Climb at Cephalon

Provigil is a sleep disorders drug. Cephalon markets Vivitrol in collaboration with its developer Alkermes(ALKS). The company had been selling Provigil by itself, but it recently signed a co-promotion deal with Japan's Takeda Pharmaceuticals.

Cephalon's full-year forecast comes with an assortment of assumptions: It assumes its experimental sleep-disorders drug Nuvigil will be approved by the FDA and launched during the second half of the year, and it assumes the cancer-pain drug Fentora will get final FDA approval and be launched early in the fourth quarter.

Both drugs have received conditional approval from the FDA, meaning the agency wants more information.

Nuvigil received a tentative OK in May . At the time, Cephalon said the major issue was what the drug label would say. But Nuvigil's path to approval appears to have become tangled with the FDA's review of another drug, Sparlon, for attention deficit hyperactivity disorder, or ADHD.

Sparlon has been the subject of several delays. In March, an FDA advisory panel recommended that Cephalon conduct more safety tests, saying it appeared that one patient out of 933 people tested had contracted a rare, dangerous skin disease called Stevens-Johnson Syndrome.

Cephalon has sent data to the agency saying the patient didn't suffer from the dangerous side effect. "We think we've given them convincing, clear data," said Paul Blake, executive vice president for worldwide medical and regulatory operations.

The FDA is expected to rule on Sparlon on Aug. 22. If the FDA approves the drug, company executives expect it to reach the market this year, aided by marketing agreement with Johnson & Johnson(JNJ). JNJ sells the ADHD drug Concerta.

The cancer-pain medication Fentora received a conditional FDA endorsement on June 30, and company executives predicted the FDA would grant final approval during the third quarter.

Cephalon's financial results were issued after markets had closed. In regular trading, the stock lost 35 cents to close at $65.55. After hours, it recaptured 18 cents.

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