Alkermes shares slump after watchdog blow to drug trial
Shares in Dublin-headquartered Alkermes fell by almost 22pc to $45.23 yesterday after the US Food and Drug Administration (FDA) refused to complete a review of a new depression drug from the company.
The company, which manufactures medicines that address the needs of people living with debilitating diseases, said that the FDA, having carried out a preliminary review of the drug, had taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness of the drug.
The FDA said that additional well-controlled clinical trials would be needed prior to the resubmission of the application for the drug, ALKS 5461. The FDA has also requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine. Describing the decision as disappointing, Alkermes CEO Richard Pops said that the company strongly disagreed with the FDA's conclusions and plans to appeal its decision.
"We strongly believe that the clinical development programme, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461's consistent antidepressant activity and a favourable benefit-risk profile," Mr Pops said.