Actavis plc confirmed that Judge Robert Sweet of the United States District Court for the Southern District of New York (New York City) has announced an intent to issue a preliminary injunction apparently requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets. Actavis believes that the ruling will have no impact on its ability to continue focusing its resources on transitioning patients to the more convenient and innovative once-daily Namenda XR.
Actavis confirmed that the Court has set a hearing for Monday, December 15 on the scope of the injunction. The company said that it will immediately appeal the decision.
"We are disappointed by today's unprecedented ruling. However, we are prepared to manage our business in a way that provides the least disruption in our ability to support the marketplace and minimize any financial impact on our company," said Brent Saunders, CEO and President of Actavis. "Physician, patient and caregiver demand for the once-daily Namenda XR is strong, with current scripts trending at more than 40 percent of the total product line and growing. We intend to continue strong promotional efforts 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. We will work to manage sales and R&D expenses to ensure that, if this decision stands, it will have minimal to no impact on our 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.