Actavis, Adamas Pharma Win FDA Approval For Alzheimer's Drug Namzaric

(RTTNews) - Specialty pharmaceutical companies Actavis plc (ACT) and Adamas Pharmaceuticals Inc. (ADMS) said Wednesday that the U.S. Food and Drug Administration has approved the New Drug Application or NDA for Namzaric for the treatment of Alzheimer's type-dementia.

The drug is expected to be launched by Actavis in 2015. Shares of Adamas Pharma are gaining more than 11 percent in pre-market trades following the announcement.

Namzaric is a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

The drug was approved by the FDA for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

According to the two companies, the therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers by reducing the number of capsules they are required to take each day for the treatment of the disease.

David Nicholson, Actavis Senior Vice President, Global Brands R&D said, "Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy. Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease."

Nicholson also noted that data has shown that combination therapy with Namenda XR and an acetylcholinesterase inhibitor or AChEI demonstrated greater improvement in cognition and global function versus an AChEI alone.

Gregory Went, Chairman and CEO of Adamas Pharmaceuticals said, "We are excited about the approval of Namzaric - the first fixed-dose combination of extended-release memantine and donepezil - and look forward to its launch by Actavis in 2015. Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."

Namzaric, formerly known as MDX-8704, is a once-daily oral capsule for patients currently taking memantine, 10 mg twice daily or 28 mg extended-release once-daily, and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

Namzaric will be available in two dosage strengths, 28/10 mg and 14/10mg for patients with severe renal impairment.

Alzheimer's disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks.

An estimated 5.2 million people in the U.S. are currently living with Alzheimer's disease, which is the fifth leading cause of death in the country among those aged 65 and older.

ACT closed Tuesday's trading at $255.88, down $5.78 or 2.21 percent on a volume of 2.62 million shares.

ADMS closed Tuesday's trading at $14.65. In Wednesday's pre-market activity, the stock is up $1.63 or 11.11 percent to $16.30.