Actavis plc is filing an emergency appeal to the US Court of Appeals for the Second Circuit seeking to immediately overturn a lower court ruling requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets. Namenda XR (memantine HCl) extended-release capsules are a higher dose, once-daily formulation of Namenda immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

On Monday, December 15, Judge Robert Sweet of the United States District Court for the Southern District of New York (New York City) issued a preliminary injunction requiring Actavis to continue distribution of Namenda immediate-release tablets. On December 11, 2014, the company first confirmed the court’s intention to issue the injunction. Actavis reiterated that the ruling will have no impact on its ability to continue focusing its resources on transitioning patients to the convenient and innovative once-daily Namenda XR and that the company is prepared to manage its business in a way that provides the least disruption in its ability to support the marketplace and minimize any financial impact.

Actavis says that current prescriptions for Namenda XR is strong and are at approximately 40% of the total product line. Actavis says it intends to continue strong promotional efforts for Namenda XR and further expand demand with the launch of a direct-to-consumer advertising campaign on January 5, which will highlight the benefits of Namenda XR for patients and caregivers. In addition, a fixed-dose combination of Namenda XR and donepezil is currently under review at the US Food and Drug Administration with anticipated approval by the end of this year.

Actavis says it manage sales and R&D expenses to ensure that, if the district court decision stands, it will have minimal to no impact on Actavis’ 2015 Namenda franchise contribution to earnings and longer-term company earnings aspirations.

Source: Actavis