The Burrill Report


Shares of Adventrx Pharmaceuticals fell nearly 60 percent after the U.S. Food and Drug Administration notified the company that it would not approve its application to market the company’s experimental non-small cell lung cancer drug Exelbine. The agency said based on inspections at clinical trial sites the authenticity of the drug products used in the pivotal bioequivalence trial could not be verified, which placed the results of the trial into question. The letter stated that the bioequivalence trial will need to be repeated to address this deficiency. In addition, the FDA requested information regarding product quality. The company said it plans to request a meeting with the FDA to discuss its response. It said it believes the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA's concerns.

Johnson & Johnson said it reached an agreement in principal with the U.S. Department of Justice to settle a criminal charge over its marketing of its antipsychotic drug Risperdal, Bloomberg reported. The company’s sales practices of the drug have been the subject of a federal investigation since 2004 relating to whether the company marketed the drug for unapproved uses. The Justice Department and the U.S. attorney in Philadelphia are pursuing civil and criminal actions in the absence of a final settlement. The company stated that certain issues remain open before a settlement can be finalized.

The U.S. Department of Justice subpoenaed the drugmaker Merck seeking information about the company’s marketing of three drugs it obtained through its 2009 merger with Schering-Plough, Reuters reported. The subpoena, disclosed in a quarterly filing with securities regulators, centers on the company’s brain cancer drug Temodar, hepatitis C medicine Peg-Intron, and hepatitis C and cancer drug Intron A. The government is seeking information dating back to 2004 as part of its investigation.

Pfizer said it has voluntarily notified the U.S. Department of Justice and the U.S. Securities and Exchange Commission of “potentially improper payments’ it made outside the United States, Dow Jones Newswires reported. The payments involve those made by both Pfizer and Wyeth, which Pfizer acquired in 2009. In previous disclosures, Pfizer said potentially improper payments are part of the subject of investigations in certain foreign countries. These include a civil and criminal probe in Germany related to tax matters, Dow Jones said.

Schering Plough pharmaceutical representatives won a victory in federal court in a nationwide class action law suit. The suit charged that Schering Plough reps often worked more than 40 hours a week but received an annual salary without overtime pay at the mandatory rate of time and one half. The amount to be distributed to the class will be determined by the court, but will likely include double damages for the violation, attorneys representing the plaintiffs said. Attorney Charles Joseph, a partner with Joseph, Herzfeld, said that the precedent for the class claim was set in the U.S. Court of Appeals for the Second Circuit, which found earlier this year that Novartis pharma reps were entitled to overtime compensation on the same grounds alleged against Schering Plough. The U.S. Supreme Court refused to hear the drug companies' appeals. The Second Circuit issued a similar ruling in a case brought by drug reps against Schering Plough, as have district courts.

The U.S. Food and Drug Administration approved changes to the drug label for Takeda Pharmaceutical’s Actos and other drugs containing pioglitazone with new safety warnings. The FDA has approved an updated label to include a warning that the use of pioglitazone for more than one year may be associated with an increased risk for bladder cancer. The new drug label also warns healthcare professionals the drug should not be used in patients with active bladder cancer or a history of bladder cancer.


August 11, 2011
http://www.burrillreport.com/article-adventrx_tumbles_on_fda%e2%80%99s_rejection_of_drug.html