West Coast Editor

Awaiting an FDA decision due this fall on Attenace to treat attention-deficit/hyperactivity disorder in children and adolescents, Cephalon Inc. sealed a co-promotion deal for the product with McNeil Consumer & Specialty Pharmaceuticals Inc.

Cephalon's stock (NASDAQ:CEPH) closed Thursday at $42.54, up $2.02.

Under the terms of the agreement with McNeil, which is a division of McNeil-PPC Inc. and a unit of New Brunswick, N.J.-based Johnson & Johnson, more than 300 McNeil sales representatives who sell J&J's ADHD product Concerta (methylphenidate) as extended-release tablets will promote once-daily Attenace in the U.S., primarily to pediatric specialists.

"McNeil, with Concerta, is considered the market leader," said Robert Grupp, vice president of corporate affairs for Frazer, Pa.-based Cephalon. "Lilly's out there, too, and Shire."

Cephalon, for its part, will deploy about 400 sales reps to promote Attenace to psychiatrists, neurologists, primary care physicians and others, which means the combined effort will have about 700 staffers pushing the compound.

The co-promotion pact will run for up to three years following the launch of Attenace, and Cephalon will pay McNeil commission fees calculated as a percentage of annual net sales. Cephalon keeps all responsibility for the development, manufacture, distribution and sale of Attenace.

Cephalon "deliberately didn't get into" further details during a conference call, Grupp told BioWorld Today, "and in terms of the market opportunity, we haven't gone there yet. But statistics show about 30 percent of patients in the ADHD market are dissatisfied with their current therapy and looking for other options."

The non-stimulant Attenace could be just the ticket. Formulated in strengths of 85 mg, 170 mg, 255 mg, 340 mg and 425 mg, it can be tailored to the needs of individual children and adolescents. The drug's active ingredient is modafinil, already sold in 100-mg and 200-mg pills as Provigil, for excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder.

"It's been on the market since the early 1990s, so it has a positive safety profile," Grupp noted.

Attenace's supplemental new drug application bears a PDUFA date of Oct. 20.

Cephalon has done more work with modafinil. This spring, the company filed a new drug application for Nuvigil (armodafinil), the second generation of Provigil. A single-isomer version of modafinil, Nuvigil targets the same disorders, but stays active longer. (See BioWorld Today, April 4, 2005.)

"We're looking at an early 2006 launch for that," Grupp said.

The firm has two compounds in Phase III trials, including the approved seizure drug Gabitril, which is being tested against generalized anxiety disorder.

"We're looking at the first half of next year" to submit an NDA, he said.

Oravescent fentanyl for breakthrough cancer pain, acquired through the $515 million buyout of CIMA Labs Inc., of Eden Prairie, Minn., yielded positive Phase III data this spring and is up for approval late next year. (See BioWorld Today, Nov. 5, 2003, and May 6, 2005.)

"We've said we're going to file this quarter and we're on track to do that," he said.

With Alkermes Inc., of Cambridge, Mass., Cephalon has a 50-50 profit-sharing deal for Vivitrex (naltrexone), a drug for alcohol dependence. The agreement, entered two months ago, is worth an additional $480 million in up-front and milestone payments. (See BioWorld Today, June 27, 2005.)

"Alkermes has that filed and they expect to get a response this fall," Grupp said.

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