The Burrill Report

Takeda Pharmaceuticals has failed to gain the backing of the U.S. Food and Drug Administration for its new diabetes treatment, alogliptin. The company has been hoping that alogliptin sales could replace revenue the company will lose when Actos, its blockbuster type 2 diabetes drug, loses patent protection later this year. The FDA has asked for more information on the use of the medicine in other countries. Takeda initially applied to the FDA in 2007 for approval to sell alogliptin and in June 2009 was told that its clinical data was insufficient based on new guidelines on cardiovascular risks. The company conducted the additional studies and resubmitted the drug for review, but the FDA again rejected it. Alogliptin is already approved in Japan and is sold under the brand name of Nesina.

The U.S. Food and Drug Administration rejected Amgen’s application to expand the approved indications for Xgeva, which is currently approved to help prevent fractures in patients with advanced prostate cancer that has advanced to the bones. Amgen was hoping to the FDA would approve use of the drug to delay the spread of tumors to the bones in patients with prostate cancer; however the agency determined that the risks outweighed the benefits of the proposed application. The new use was rejected after an advisory panel voted against it because it was linked to a jawbone-destroying condition. Amgen has said that it plans to work with the FDA to determine the next steps for the expanded indication and noted that the FDA’s action has no impact on the already approved indication of Xgeva.

Targacept said that it would eliminate 65 jobs, or nearly half of its work force, as it finds ways to restructure and save money after the late-stage failure of its experimental depression drug. Targacept had been developing its depression drug, TC-5214, in partnership with AstraZeneca but was forced to end development in March after it failed to meet the primary goals of multiple late-stage clinical trials. In April, Targacept received more bad news when another experimental drug, for the treatment of asthma, failed to meet end-points in another clinical trial. The company expects to save $12.9 million a year from the job cuts and is planning on updating its full-year guidance when it reports its first-quarter numbers in May. Shares of Targacept slipped 23 cents to $4.79 after the announcement. Burrill & Company, publisher of The Burrill Report, is an investor in Targacept.

Repligen said that the U.S. Food and Drug Administration has cancelled an advisory-committee meeting to review its new drug application for RG1068, or SecreFlo, which is used to detect pancreatic-duct abnormalities in patients with pancreatitis. Repligen is anticipating that the FDA will ask for additional clinical trial data. The advisory committee was scheduled to meet on May 31. “While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need,” says CEO Walter Herlihy. Shares nosedived 41 percent after the announcement, leading to a halt in trading.

The U.S. Food and Drug Administration is changing the label for Merck’s recently approved Victrelis, a treatment for hepatitis C, to indicate that it should not be taken in tandem with some widely used HIV medicines. “Co-administration is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV in the blood to increase,” the FDA said in a statement. The FDA first warned Merck of the issue in February 2012 based on results of a drug interaction study that found that Victrelis reduced the concentrations of HIV drugs in the blood of patients taking Victrelis and the widely used HIV treatment Norvir with one of three other anti-HIV pills.


April 26, 2012
http://www.burrillreport.com/article-takeda_fails_to_win_fda_approval_for_diabetes_drug.html