FDA Investigates Deaths in Connection With Recalled J&J Medicines: Biotech's Latest Mishaps

Includes: GTXI, ITMN, JNJ
by: The Burrill Report

The U.S. Food and Drug Administration is investigating reports of complications with dozens of recalled children's medications made by Johnson & Johnson (NYSE:JNJ), including 30 deaths, but so far no direct link has been found, according to a Congressional staff report, Reuters reported. “At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” according to the report. “FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines.” A Congressional hearing May 27 looked into manufacturing problems at a J&J facility that led to contamination of Children’s Tylenol and other drugs.

Stem Cell Therapeutics said its therapy for patients with acute ischemic stroke failed in a mid-stage clinical trial. While NTx-265 was well tolerated, there was no statistical difference in the changes observed in patients receiving its treatment and those given a placebo. “The profile and magnitude of the placebo response is extremely surprising and merits further examination” says Alan Moore, CEO and President of Stem Cell Therapeutics. “We are currently conducting a validation review process of the full trial.” NTx-265 is a sequential administration of human chorionic gandotropin followed by erythropoietin.
GTx (NASDAQ:GTXI) said top lines results from a late-stage trial of toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia failed to demonstrate a statistically significant difference compared to a placebo. The incidence of prostate cancer was lower in men receiving toremifene and showed a 10.2 percent relative risk reduction at three years. In the study, there were no clinically significant differences in the adverse event safety profile between men treated with toremifene 20 mg and men receiving placebo.
InterMune (NASDAQ:ITMN) will cut about 60 employees or 40 percent of its workforce following its failure to win U.S. Food and Drug Administration approval for its idiopathic pulmonary fibrosis drug pirfenidone. The cut are being made mostly in the commercial and discovery research areas, the company said in a regulatory filing. When completed, the company expects to have about 85 employees. The cuts are expected to save about $12 million a year. The FDA wants an additional clinical trial to support the efficacy of pirfenidone in IPF patients.
Teva Pharmaceutical Industries (NASDAQ:TEVA) said it will stop producing the sedative propofol, Reuters reported. The decision following an FDA warning letter in December over lapses at the company’s plant in Irvine, California.
The U.S. Food and Drug Administration warned of a possible increased risk of fractures of the hip, wrist, and spine in people with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk. Proton pump inhibitors, available by prescription and over-the-counter, work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease or GERD, stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).
The U.S. Food and Drug Administration warned about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli. The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence. Both Xenical and Alli are medications that contain the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli. Though rare, the agency has identified 13 cases of severe liver injury, 12 of which were reports from outside the United States.