Pfizer has made a deal with the FDA over now-subsidiary Wyeth’s marketing practices for its immunosuppressive drug Rapamune. The drug was approved in 1999 to prevent transplant rejection in kidney transplant patients. Two lawsuits, however, brought Wyeth to the Department of Justice’s attention, and both were brought by former sales reps. Wyeth pleaded guilty to a misbranding violation under the Federal Food, Drug and Cosmetic Act in the deal announced Tuesday, and is shelling out $157.58 million in criminal fines and forfeiting assets that total an additional $76 million. The DOJ’s settlement summary says these fines are due to allegations that Wyeth “trained its national Rapamune sales force to promote the use of non-renal transplant patients,” and that Wyeth supported this promotion by providing training materials to help them close the non-renal deals. Wyeth was also accused of using bonuses to push reps further along the off-label trail. In addition to this $233 million, Pfizer is also putting up $257.4 million to settle potential civil liability linked to the off-label marketing Wyeth allegedly used from 1998 through 2009. This round of cash is over allegations that Wyeth violated the False Claims Act by promoting unapproved uses, which means they should not have been covered by government programs like Medicare and Medicaid. The unapproved use accusation includes encouraging that patients be switched from one immunosuppressant to Rapamune. The $257.4 million is going to be divvied up between the feds and the states. “This was a systemic, corporate effort to seek profit over safety,” US Attorney for the Western District of Oklahoma Sanford Coats said in a Department of Justice statement. Tuesday’s settlement is an add-on of sorts for the drug maker. Pfizer was already under a Corporate Integrity Agreement as of 2009 over charges regarding its own behavior.
Moody’s Investor Services has slashed its GlaxoSmithKline rating from stable to negative, reports Reuters. The news service says the recent scandals in China are not what triggered the change, which was due to concerns over the British firm’s cash outflows, which include its debt-based purchase of Human Genome Sciences in 2012, share buybacks and legal settlements.
AstraZeneca is betting $350 million that FibroGen’s experimental anemia drug, FG-4592, has potential. The late-stage oral compound is for anemia linked to chronic kidney disease and end-stage renal disease. In addition to the $359 up front, AstraZeneca is promising up to $465 in additional milestone payments and tiered royalties if all works out. As noted by Bloomberg and other sources, a positive outcome would be a particular boon for the drug maker, which has a drug portfolio that is increasingly exposed to generic competition. AstraZeneca reports its second quarter results tomorrow. Generics helped drive down first-quarter sales 12% compared to the same period last year.
The FDA is considering a new pain medication. Missouri-based Mallinckrodt announced Monday that the regulator is giving its controlled-release oral oxycodone-acetaminophen combination priority review status.
