Actavis will appeal injunction requiring continued distribution of NAMENDA IR

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.

Physician, patient and caregiver demand for the once-daily NAMENDA XR is strong, with current scripts trending at approximately 40 percent 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 U.S. 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.

Dosing and Administration

• The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
• It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
• It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA tablet.

Special Populations

• NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
• A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).

IMPORTANT SAFETY INFORMATION

Contraindications

• NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

Warnings and Precautions

• NAMENDA XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels and a possible increase in adverse effects.
• NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.

Adverse Reactions

• The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).

Drug Interactions

• No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.