Novartis Pulls the Plug on Drug Trial: Biotech's Latest Mishaps

by: The Burrill Report

Novartis (NYSE:NVS) has stopped a trial of Antisoma’s experimental drug for non-small cell lung cancer after an interim analysis showed that the drug, ASA404, was unlikely to provide any benefit as a second-line treatment for the disease. As a result, the company expects to take a charge of $120 million in the fourth quarter of 2010. Glyn Edwards, CEO of Antisoma, says the findings mirror the findings from another study and “come as no surprise.”

Stellar Pharmaceuticals (OTC:SLXCF) said its U.S. licensee, Watson Pharmaceuticals (WPI), has notified it that a preliminary analysis of data from a pilot study of the company’s Uracyst product to treat interstitial cystitis/painful bladder syndrome failed to demonstrate statistical significance in its primary endpoints. Watson has elected not to proceed with Uracyst for the United States market. Stellar said it is reviewing the Watson study to determine what role if any the trial design had on the overall results. Based on the findings of that review it will determine its strategy for Uracyst in the United States. In June 2009, Watson received conditional approval for an Investigational Device Exemption to conduct clinical work with Uracyst from the U.S. Food and Drug Administration in the United States.

Ikaria has withdrawn its plans for an IPO because of weak demand despite slashing the size of its offering, Dow Jones News reported. The New Jersey-based biotech with a treatment for respiratory failure in newborns, had hoped to raise as much as $195 million at one point. It is developing biotherapies for critical care. The company’s investors include ARCH Venture Partners, Venrock, and 5AM Ventures.

Optimer Pharmaceuticals (NASDAQ:OPTR) said it is terminating a trial of its experimental drug to treat infectious diarrhea because trial patients developed more skin rashes than expected, Reuters reported. The company, which reported top-line results from a late-stage study of the drug last year, said it will investigate the rashes. It notified the U.S. Food and Drug Administration of its decision to terminate the study of possible interaction between the drug Pruvel and antacids. The company said it could not estimate when it would begin a new study or submit an application to market the drug until its investigation was over.

SuperGen (SUPG) said it has discontinued clinical development of its early-stage experimental drug for refractory prostate and lymphoma because of dose-limiting cardiac safety concerns. The company said even though it was discontinuing work on the drug known as SGI-1776, a PIM kinase candidate, it will continue its PIM inhibitor program. Supergen said the discovery team has identified backup candidates that initially appear to lack some of the liabilities seen in SGI-1776.