For Glaxo, XR May Not Mean Extra Revenue
1 CommentBy Ed Silverman // June 17th, 2008 // 2:47 pm
Until recently, the drugmaker had - past tense - a strategy for extending sales of its biggest drugs. The idea seemed simple - win FDA approval for new versions. The only problem is that the FDA is failing to cooperate and lower-cost generics are getting to market before Glaxo has a chance to sell its reconfigured drugs, The Wall Street Journal notes.
For instance, the FDA just approved Requip XL for treating Parkinson’s after several delays. But generics hit the US market last month, which the paper notes makes it harder for Glaxo to persuade docs to prescribe the more expensive Requip XL. One modified drug Glaxo rolled out last year, the Coreg CR cardiovascular pill, cost four times as much as the generic. (XR, by the way, generally refers to Extended Release).
In the past, the Journal writes, the FDA approved most modifications, also known as line extensions, without much question. But analysts says the FDA is now treating modifications as a lower priority because it sees them as less medically necessary.
Chris Viehbacher, who heads Glaxo’s North American pharma unit, recently said the FDA asked the drugmaker to defend Requip CR, a “controlled release” version to treat restless legs syndrome, which simply enters the bloodstream more gradually.
“Requip CR did not make it to market. Why? Not because it’s not safe. Not because it’s not efficacious. The FDA said, ‘Yeah, you’ve got all that. But tell me why you’re better than (Requip).’ Well, that was an unprecedented question from the FDA,” Viehbacher said at an investor conference last month, according to a transcript. Instead of defending Requip CR, Glaxo withdrew its application.
Henry
The WSJ completely missed it with this one.
On what basis is Mr. Ward the stock analyst basing his statement that FDA is treating line extensions as lower priority. Last I knew FDA had to meet PDUFA timelines with line extensions as well as with NMEs. The veracity of this statement could have been easily checked by the reporter.
What about Mr. Viehbacher’s statement. Last I checked the FD&CA has standards for approval of a modified release product. Either it met it or it didn’t, if it met it the FDA has no choice but to approve the product. Mr. Viehbacher is essentially safe to claim anything he wants to and FDA can’t respond.
Why did Glaxo simply withdraw the application and not appeal the decision within the FDA? This is extremely strange. The reporter could have and should have asked Glaxo to provide copies of any communications with the FDA. Typically when a sponsor withdraws the application the FDa writes and acknowledgement letter that may include the reasons. Also there must be other communications. Why didn’t the reporter ask Glaxo for copies of any communications. Better yet why not ask Glaxo to waive confidentiality and let the FDA release copies of any reviews, etc..
Typically when big companies work on a line extension they put their D team to work on it. Seems to me that Glaxo management may not have provided sufficient oversight regarding the project and was unaware of major problems with their program that jeopordized their franchise.
If I were a big investor in Glaxo stock I’d sure be interested if Glaxo management made my investment go south because of poor management.
Looks to me like this article is more about Glaxo executives trying to divert blame from themselves.