FDA to require abuse plans from pain drug developers:
>>UPDATE:King Pharma, Painkiller Makers Slide On FDA Plan
Last update: 2/9/2009 5:02:29 PM
(Updates with King Pharma statement starting in eighth paragraph)
By David Benoit
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Shares of some pharmaceutical companies, including King Pharmaceuticals Inc. (KG), traded lower Monday, following the U.S. Food and Drug Administration's announcement it would require drug makers to develop plans to combat painkiller abuse, possibly slowing the applications for drugs in the pipeline.
Analysts said the plan being initiated could require the companies to spend more time and money in getting their drugs and treatments approved and to market.
The FDA said Monday it had sent letters to 16 drug manufacturers on Friday alerting them that the agency would be instituting a risk evaluation and mitigation strategy for opioid drugs, which are marketed narcotics such as Oxycodone, Morphine and Fentanyl. The review will look to mitigate the harmful effects of the drugs when used legally as well as deal with illegal uses as FDA officials said they've seen reports of inappropriate prescribing by doctors.
"The FDA, drug manufacturers, and others have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs," the FDA said in a release on its Web site. "Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade."
Some of the companies that received the notices saw shares slide on Monday, including King Pharmaceuticals, Endo Pharmaceuticals Holdings Inc. (ENDP) and K-V Pharmaceutical Co. (KVA). King closed down 6.8% to $8.21, while Endo slipped 2.3% to $22.97 and K-V lost 8.8% to 65 cents.
"This has been a long time coming, there has been a huge push to sort of crack down," said Kevin Kedra, an analyst at Gabelli & Co. "We are talking both time and money."
The FDA said that the strategy would include educating doctors on prescribing and added that it would host a meeting with drug manufacturers early next month as well as meet with other federal agencies and the public in the coming months.
King Pharmaceuticals Vice President of Corporate Affairs James Green said in an email that King welcomed the opportunity to discuss the matter and was committed to "responsible pain management" for its opiate Avinza.
He also added that the company, at this time, remained unsure of how the plan would change the timeline for the application for its promising new morphine drug Embeda.
"The agency has not shared with us whether the process for developing REMS for currently approved opioid products will affect the review timeline for the Embeda [new drug application]," he said. "The Embeda [application] contains a proposed REMS that we believe is detailed and comprehensive."
Endo Pharmaceuticals spokesman Blaine Davis said his company would look forward to working with the FDA on the initiative that it believed was important as well.
The release also named a swath of generic drug makers, including Teva Pharmaceutical Industries Ltd. (TEVA), Watson Pharmaceuticals Inc. (WPI) and Impax Laboratories Inc. (IPXL), which were seeing less weight on their shares in recent trading. Kedra said that could be because they don't have the structure to implement the changes as easily, essentially giving them a short break from the new regulations.
In all, 24 different products were listed for the review, with uses ranging from heavy pain management for cancer patients to other chronic conditions.
In a separate release, K-V Pharmaceuticals also announced it was cutting 700 jobs on Monday as it looks to continue to deal with suspensions and recalls of some of its products after the drug maker discovered an oversized drug tablet in December.
-By David Benoit, Dow Jones Newswires; 201-938-2472; david.benoit@dowjones.com<<
Cheers, Tuck |
