Insys Planning To Sell Off Opioid-Related Assets, Following Settlement In Federal Investigation
Potential sell-off plans include Insys' Subsys, a mouth-spray version of the fentanyl painkiller, and formulations of buprenorphine. In other pharma news, the FDA continues to find quality control problems at Akorn manufacturing plants.
The Wall Street Journal:
Insys Looks To Sell Opioid-Related Assets, Including Subsys
Insys Therapeutics Inc. is looking to sell its opioid-related assets, including Subsys, the fentanyl painkiller that fueled its success and later landed it in legal trouble for aggressive sales practices. Subsys, a mouth-spray version of fentanyl, has been commercially available in the U.S. since 2012 to treat cancer-related pain. Its sales helped make Insys the best-performing initial public offering in 2013. Those fortunes turned when former CEO and co-founder John Kapoor and other executives and managers were arrested and indicted last year as part of a federal probe into alleged bribes for doctors to prescribe large amounts of the drug. They have pleaded not guilty. (Armental, 11/6)
Akorn Is Tagged — Again — By The FDA For Problems At A Manufacturing Plant
Despite disagreeing with accusations that it fails to comply with regulatory practices, Akorn is something of a full employment act for Food and Drug Administration inspectors. The agency released another in an ongoing stream of inspection reports that have found quality control problems at different Akorn plants in the U.S. and elsewhere. The concerns included a failure to review unexplained discrepancies in batches and consistently investigate issues with batch samples; procedures for quality control were not in writing; and a failure to validate procedures to avoid contamination. (Silverman, 11/5)