Court Rules Against Actavis in Namenda CaseBy
Actavis has confirmed that a panel of the US Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets, which are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Actavis has commercialized an extended-release version of the drug, Namenda XR (memantine HCl) , a higher dose, once-daily formulation of Namenda and had sought to discontinue the immediate-release version of the drug.
“While we are disappointed by the Court’s decision to uphold this ruling, we intend to continue our strong efforts to convey the significant benefits of Namenda XR to physicians, patients and caregivers,” said Brent Saunders, CEO and President of Actavis, in a company release. “Patient demand for Namenda XR is currently trending at more than 50% of the total product line’s days of therapy and growing, underscoring the strong physician, patient and caregiver demand for our once-daily product.”
In addition, Actavis recently launched once-daily Namzaric, a fixed-dose combination of Namenda XRÂ® and donepezil that provides another treatment option for patients with moderate to severe Alzheimer’s disease. Since the launch of Namenda XRÂ® in 2013, the two medications, Namenda XRÂ® and donepezil, have been commonly prescribed in combination with one another to treat the symptoms of moderate to severe Alzheimer’s disease. Donepezil is the active ingredient in Aricept (donepezil hydrochloride), which is indicated for the treatment of mild to severe dementia of the Alzheimer’s type. Actavis and Adamas collaborated on the development of the fixed-dose combination. Actavis has exclusive US commercialization rights while Adamas will retain exclusive commercialization rights outside of the US.
Actavis noted that the company will continue to manage sales and R&D expenses to ensure that the appeals court’s decision will have minimal to no impact on its 2015 Namenda franchise contribution to earnings and longer-term company earnings goals.