Actavis plc, a global, integrated specialty pharmaceutical company, confirmed that it 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.

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, 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.

Physician, patient and caregiver demand for the once-daily Namenda XR is strong, with current scripts trending at approximately 40 per cent of the total product line.  Actavis 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 significant 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.

Further, the Company noted that it will work to 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.

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. Its mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of Namenda XR was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).

Namenda XR 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician's Interview-Based Impression of Change Scale (0.3. unit mean difference).

There is no evidence that Namenda XR or an AChEI prevents or slows the underlying disease process in patients with Alzheimer's disease.

Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.