J&J Announces Drug Recall: Biotech's Latest Business Mishaps

by: The Burrill Report

Johnson & Johnson’s (NYSE:JNJ) McNeil Consumer Healthcare Unit announced a voluntary recall of certain over-the-counter infants’ and children’s liquid medicines because of problems with quality. The company said the recall is not being pursued because of adverse medical events, but instead as a precautionary measure. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. The affected products include children’s Tylenol, Motrin, Zyrtec and Benedry. While the company said the potential for serious medical events is remote, it advised consumers who have purchased these recalled products to discontinue use. The company also said it temporarily suspended production at its Fort Washington, Pennsylvania plant where problems were observed.

Bristol-Myers Squibb (NYSE:BMY) said that the U.S. Food and Drug Administration notified it that it would not approve its Biologics License Application for belatacept in kidney transplantation without additional data. The agency did not ask for additional clinical studies but wanted the 36-month data from the ongoing late-stage studies to further evaluate the long-term effect of belatacept. The company said it will work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the phase 3 studies. Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy.

The FDA dashed investors' high hopes for InterMune (NASDAQ:ITMN), sending the company's shares crashing as it rejected the lung disease drug, Pirfenidone, instead of approving it as expected. In a letter to the company, the agency asked InterMune to conduct an additional clinical trial to support the efficacy of Pirfenidone in patients with idiopathic pulmonary fibrosis, a fatal lung disease that affects about 200,000 people in Europe and the United States combined. InterMune shares fell by 75 percent to $11.38 on the news, from a pre-decision close of $45.44 [see story].

Sepracor, a U.S. subsidiary of Dainippon Sumitomo Pharma (OTC:DNPUF), said that the U.S. Food and Drug Administration has notified it that it would not approve its experimental epilepsy drug Stedesa at this time. Sepracor said it will meet with the FDA to discuss the decision.

Newron Pharmaceuticals (OTC:NWPHF) said top-line results of its phase 2b/3 study of its experimental drug ralfinamide in patients with at least moderate neuropathic low back pain did not show any significant difference between it and a placebo. The 12-week study enrolled 411 patients with chronic neuropathic low back pain of at least moderate severity and evaluated the safety and efficacy of two dose regimens of ralfinamide compared to placebo. Ralfinamide was well tolerated, with no clinically significant differences from placebo on safety measures.

The U.S. Supreme Court rejected Pfizer’s (NYSE:PFE) appeal of a shareholder suit that charged the drug giant misrepresented the safety of its blockbuster pain drug Celebrex, The Wall Street Journal reported. The suit charged that Pfizer's Pharmacia unit withheld the full results of a study that showed Celebrex was no safer than less expensive anti-inflammatory drugs. Pfizer contended that investors missed a two-year statute of limitations to bring the lawsuit. But the plaintiffs argued that there was no evidence of a possible fraud until the Washington Post reported on the missing Celebrex data in August 2001, meaning their April 2003 lawsuit was within two years of that revelation.

The U.S. Food and Drug Administration is investigating possible risks from Abbott Laboratories (NYSE:ABT) HIV drug Kaletra, GlaxoSmithKline (NYSE:GSK) prostate drug Avodart, and other medicines, Reuters reported. The agency said it was investigating reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus. The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck's (NYSE:MRK) prostate drug Proscar and baldness treatment Propecia. The disclosures came in a quarterly FDA release of safety probes.

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