Cephalon's Provigil to piggyback Rozerem in promotion deal

In hopes of gaining marketing momentum from the push behind Rozerem, Cephalon has entered into agreement with Takeda Pharmaceutical to co-promote the biotech firm’s first-in-class wakefulness drug Provigil (modafinil) in the US, alongside the Takeda sleeping pill.  Beginning in July, 500 Takeda sales reps will also begin promoting Provigil, boosting the total Provigil sales force to 900 people. The one-way co-promotion agreement will run for three years with an option to renew annually. As part of the deal, Cephalon will also be given the option to utilize the Takeda sales force for the promotion of Nuvigil (armodafinil) tablets, a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil, awaiting FDA approval. Cephalon will pay Takeda a royalty based on certain sales criteria for Provigil and Nuvigil, the companies said. Additionally, Cephalon will retain all responsibility for development, manufacturing, distribution and sale of Provigil, with both companies to form a joint commercial committee to manage Provigil promotion. Mark Booth, president of Takeda Pharmaceuticals North America said in a statement, “Adding Provigil to our new central nervous system portfolio and having our representatives promote it alongside Takeda's Rozerem will be of great value to physicians and patients because of the respective roles of each product in the sleep-wake cycle.” Provigil is a first-in-class medication in a new class of wake- promoting drugs designed to work selectively through the sleep/wake centers to activate the cortex of the brain. 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.