The companies are currently awaiting an FDA decision on whether or not to approve Modafinil for an indication to treat ADHD in children and adolescents. Cephalon submitted the application to the FDA in December 2004 and anticipates a response on October 20, 2005.
More than 300 McNeil sales representatives, who currently sell the ADHD product Concerta, will promote modafinil upon approval in the US primarily to pediatric specialists. Cephalon will use its existing central nervous system specialty sales force of approximately 400 representatives to promote modafinil to psychiatrists, neurologists, primary care physicians, and other appropriate health care professionals.
The co-promotion agreement will run for up to three years following the date of commercial launch of Modafinil. Cephalon will pay McNeil commission fees calculated as a percentage of annual net sales of Modafinil during the term of the agreement. Cephalon will retain all responsibility for the development, manufacture, distribution, and sale of the product. Cephalon and McNeil will form a joint commercial committee to manage the promotion of the drug.
“Our company has extensive experience with ADHD and the pediatric medical community,” said Colin Watts, president, McNeil Consumer & Specialty Pharmaceuticals. “We are excited about the prospect of collaborating with Cephalon on this new ADHD therapy.”