Anti-emetics could be next in Cephalon's oncology bid.(Despite Modafinil, FTC Woes)(Psychopharmacologic Drugs Advisory Committee's licensing of Sparlon, Antipsychotic agent)

Publication: Bioworld Financial Watch

Publication Date: 28-AUG-06

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COPYRIGHT 2006 A Thomson Healthcare Company

Cephalon Inc.'s decision earlier this month--after a not-approvable letter from the FDA--to drop Sparlon (modafinil), the oral therapy for attention-deficit/hyperactivity disorder, put a 12-percent dent in the company's share value.

Some might have seen it coming. The agency's Psychopharmacologic Drugs Advisory Committee in March voted unanimously against recommending the drug, calling Sparlon effective for its intended use but wanted more safety data in children and adolescents with ADHD. After the vote, Cephalon reduced its total sales guidance by $100 million for this year, setting the new range between $1.45 billion and $1.50 billion.

The problem was a suspected case of the rare but serious skin rash known as Stevens-Johnson syndrome in one patient given Sparlon during Phase III trials. Cephalon disputed the diagnosis and noted that the boy's treating physicians classified the rash as erythema multiforme. Other dermatologists who looked at photos believed the same.

Regulators were not convinced, wanted more trials and would not guarantee that additional studies would quell the...

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