The Food and Drug Administration is scheduled to decide Thursday whether Cephalon ( CEPH) can enter a new market as part of the company's ambitious product expansion. Regulators are reviewing Attenace for treating attention deficit hyperactivity disorder in children aged 6 to 17. Attenace is a version of Provigil, Cephalon's best-selling drug prescribed for several sleep disorders, including narcolepsy. Although a favorable FDA ruling won't help Cephalon until early next year, it should provide support for a stock that has had spurts of volatility . The FDA review comes as Cephalon makes a bid to introduce five products within a year and a half. "The company is nearing a crossroads in its 18-year history," as it bets on new drugs to more than offset lost revenue caused by upcoming generic competition for two major products, says Adam Greene of First Albany Capital in a recent research report. At the same time, the U.S. market for ADHD drugs is in flux, giving Attenace an attractive opportunity, says Ken Kulju of Credit Suisse First Boston in a recent report to clients. "We believe Attenace possesses attractive commercial potential," thanks in part to "commendable efficacy and a relatively clean side effect profile," says Kulju, who is neutral on the stock.
ADHD market leaders -- Adderall XR from Shire Pharmaceuticals Group ( SHPGY) and Concerta from Johnson & Johnson ( JNJ) -- have experienced a series of ups and downs in the U.S. during the last 18 months. Lately, they're on the upswing, with Adderall XR holding a slight lead, according to the health-care data firm IMS Health. In a distant third place is Strattera from Eli Lilly ( LLY), which has experienced a gradual slide in prescriptions. Analysts say a stricter warning label about possible liver problems could be one cause for Strattera's slump , while a new warning about suicidal thinking among young users could hurt sales, too.