Mylan agrees $465 million settlement with DoJ over EpiPen

Beleaguered Netherlands-incorporated drugmaker Mylan (Nasdaq: MYL) said on Friday that its subsidiary, Mylan Inc, has agreed to the terms of a $465 million settlement with the US Department of Justice and other government agencies that will resolve questions that have been raised about the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program.

Mylan shares, which have been battered in recent week over drug pricing controversies and congressional investigations, gained 11% in after-hours New York trading Friday to $39.72.

The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc or any of its affiliated entities or personnel, the company said. The question in the underlying matter was whether EpiPen Auto-Injector was properly classified with the Centers for Medicaid and Medicare Services (CMS) as a non-innovator drug under the applicable definition in the Medicaid Rebate statute and subject to the formula that is used to calculate rebates to Medicaid for such drugs. EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007 based on longstanding written guidance from the federal government.