FRAZER, Pa. (AFX) - Biopharmaceutical company Cephalon Inc. said Monday that it will team with Takeda Pharmaceuticals North America Inc. to co-promote Provigil Tablets for the treatment of excessive sleepiness in the United States.
In July, 500 Takeda sales representatives will begin promoting Provigil to primary care physicians and other appropriate health care professionals in the United States. At that time, the Cephalon and Takeda sales force co-promoting the drug will consist of about 900 people.
Robert P. Roche, Jr., executive vice president, worldwide pharmaceutical operations, of Cephalon, said,' Takeda has an established presence in the central nervous system therapeutic area, and they will enable us to significantly increase market penetration as we seek to maximize Provigil sales growth over the next several years.'
The co-promotion agreement will run for three years with an option to renew annually. As part of the agreement, Cephalon also has an option to use the Takeda sales force for the promotion of Nuvigil Tablets, assuming Food and Drug Administration approval of this new product candidate. On May 1, Cephalon announced it received an approvable letter from the FDA for Nuvigil.
Cephalon will pay Takeda an undisclosed royalty based on certain sales criteria for both drugs. Under the agreement, Cephalon will retain all responsibility for the development, manufacture, distribution and sale of Provigil, and the companies will form a joint commercial committee to manage its promotion.
Modafinil, the active ingredient in Provigil, is the first medication in a new class of wake-promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain. The medication is currently approved in more than 20 countries.
In 2004, the FDA approved Provigil for improving wakefulness in patients with excessive sleepiness associated with shift work sleep disorder and as an adjunct to standard therapies for obstructive sleep apnea/hypopnea syndrome. Provigil was originally approved in 1998 for improving wakefulness in patients with excessive sleepiness associated with narcolepsy.
Shares of Cephalon fell $1.15, or 2 percent, to close the regular session at $55.56 on the Nasdaq, and then slipped 94 cents to $54.62 in aftermarket activity.
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