Shire, Noven receives FDA approvable letter for Daytrana ADHD drug

By Angela McDaniels

Seattle, Dec. 23 - Shire plc said it has received an approvable letter from the Food and Drug Administration for Daytrana (methylphenidate transdermal system), an investigational transdermal patch designed for once-daily use to treat attention deficit-hyperactivity disorder in children aged six to 12 years.

The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance and post-marketing studies. Shire said it is initiating dialog with the FDA to address these issues.

Shire and Noven Pharmaceuticals Inc. submitted an amended New Drug Application for Daytrana in June. Daytrana is licensed globally to Shire by Noven.

Shire said it hopes to reach final agreement with the FDA concerning Daytrana to allow for a launch during the first half of 2006.

If the product is approved, Noven will receive a $50 million milestone payment from Shire and may earn additional milestone payments of up to $75 million depending on the level of Shire's commercial sales of the product.

In addition, Noven expects to earn a profit on the manufacture and supply of the finished product to Shire, the company said.

"We look forward to working with the FDA to agree on the final labeling for Daytrana. As the first and only non-oral medication for ADHD, Daytrana, if ultimately approved, will be a welcome new alternative to current therapies for patients diagnosed with ADHD," Shire chief executive officer Matthew Emmens said in a company news release.

Shire said ADHD affects 7.8% of all school-age children, including more than 4 million in the United States.

Shire is a pharmaceutical company based in Basingstoke, England, that develops products in the areas of central nervous system, gastrointestinal, renal diseases and human genetic therapies.

Noven is a pharmaceutical company with headquarters in Miami that develops transdermal drug- delivery technologies and prescription transdermal products.

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