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12:00 AM
Dec 05, 2005
 |  BioCentury  |  Product Development

FDA's Daytrana curve ball

FDA reviews of compounds posted prior to panel meetings often paint the most negative picture of efficacy and side effects, in part, the agency says, because it wants to focus attention on issues of medical or scientific uncertainty that can benefit from outside expertise. But it's altogether another thing when FDA posts negative briefing documents that don't actually reflect its views, given the instant damage done to companies and investors.

Noven Pharmaceuticals Inc. was the victim last week, losing $55.2 million (17%) of its market capitalization on Thursday because FDA posted briefing documents that senior agency officials knew at the time misrepresented the current views of the lead reviewer of the Daytrana methylphenidate patch for pediatric ADHD. The stock did not trade on Friday, when the Psychopharmacologic Drugs Advisory Committee (PDAC) unanimously recommended approval.

The turn of events was another loop in Daytrana 's three-and-a-half year roll-ercoaster ride through the FDA. Shire Pharmaceuticals Group plc (LSE:SHP; SHPGY), which licensed the Daytrana methylphenidate transdermal system (MTS) from NOVN in 2003, was unscathed by the episode. On Thursday, SHPGY was up $0.41 to $36.95 on NASDAQ, while SHP was up 29p to 733p in London trading on Friday.

The impact on NOVN (Miami, Fla.) and its investors is a new example of the unintended consequences of poorly managed releases of FDA advisory committee briefing information.

In September, FDA accidentally posted briefing documents for Revlimid lenalidomide from Celgene Corp. (CELG, Summit, N.J.) a day earlier than planned. It pulled the documents off the Internet a couple of hours later when it learned of the incident, providing a lucrative arbitrage opportunity for those who learned of the slip (see BioCentury, Sept. 19).

Last week's saga started with the posting of the Daytrana briefing documents one day in advance of Friday's PDAC meeting. As usual, journalists and investors quickly scrutinized the documents for an early indicator of the prospects for approval and a roadmap to issues that would be discussed at the meeting.

In a cover memo introducing the agency's reviews to committee members, Thomas Laughren, director of the Division of Psychiatry Products, noted that FDA had issued a nonapprovable letter for Daytrana in April 2003, primarily because of "a concern about unacceptable levels of insomnia, anorexia, and...

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