Henry - I know the feeling. I have a Nicole too (just turned 14) and she doesn't take losing easy either.
Back to Ligand: I don't know if this has been discussed yet (it's not as easy as it used to be to review a days worth of posts) but I would guess that the recall of Redux and Pondimin could have some major ramifications on the leptin program. Studies for obesity drug side effects will have to be more rigorous, and off-label use will be more closely scrutinized. Granted, it will also make things tougher for AMGN and other competitors, but the Street's perception of prolonged approval periods and possibly reduced indications could also hurt LGND.
Here's a Reuters article on the subject (again, sorry if it's already been discussed):
Monday September 15 8:37 PM EDT
Closer FDA scrutiny seen after obesity drug recall
NEW YORK, Sept 15 (Reuter) - Although two new obesity drugs could reach U.S. drugstores within the next year and others are in earlier stages of testing, they can all expect heightened FDA scrutiny after Monday's recall of Redux and Pondimin.
``The (U.S.) Food and Drug Administration will be extra careful on side effects of obesity drugs. Any that are approved will require lots of warnings so that if physicians take chances prescribing them, those physicians will be held responsible,'' said drug analyst Hemant Shah of HKS & Co.
Interneuron Pharmaceuticals Inc (IPIC) and marketing partner Wyeth-Ayerst Laboaratories, a division of American Home Products Corp (AHP), said Monday they were recalling Redux just 15 months after its launch.
And Wyeth said it was also immediately recalling Pondimin, an older drug whose chemical name is fenfluramine hydrochloride, because of fresh clinical data linking it and Redux to possible heart-valve problems among patients.
``For Redux, there were no warnings of any real significance when the product was approved, Shah said.
``Instead, Redux was used without restrictions and with combinations of other drugs,'' Shah said.
But in the future, he predicted the agency will require limitations ensuring obesity drugs are prescribed only for the truly obese. ``And the agency will probably impose promotional restrictions on the drugs,'' he added.
``The FDA and drug companies will have to be more cautious now,'' said Mehta & Isaly analyst Edmund Debler. He said many of the 2.4 million Redux prescriptions written within only six months of its launch were no doubt unwarranted.
POSSIBLE LOST DATA ``If you weigh 400 pounds and are in danger of dying from obesity it might have been worth risking heart-valve trouble. But not for those who want to lose 20 pounds and are too lazy to exercise,'' he said.
Wall Street observers said Knoll Inc, a unit of German chemicals group BASF AG (BASF.F), has already received an ``approvable letter'' from the FDA indicating its candidate drug for obesity could be cleared for marketing in the next few months.
Roche Holding AG (ROCZG.S) last month announced it was delaying the launch of its candidate obesity drug, Xenical, while it gathered data on breast cancer cases seen in clinical trials.
The Swiss drugmaker said it expected to resubmit its application within several months to the FDA, meaning approval could not be expected for at least another year.
Other drugs in early clinical trials and three to six years from possible launch are are Amgen Inc's (AMGN) leptin and Neurogen Corp's (NRGN) NGD 95-1. |
