Forest and Merz : FDA Approval of NAMENDA XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type

Jun 21, 2010 - Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA. The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with NAMENDA XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.


NAMENDA XR will be covered by U.S. Patent No. 5,061,703, which is listed in the Orange Book for NAMENDA and expires in April 2015. In addition, Forest owns pending patent applications related to NAMENDA XR. The companies are determining the appropriate commercialization strategy and market timing to ensure a successful franchise... Forest Laboratories' Press Release -

Merz and Acumen Partner in An Innovative Alzheimer's Approch

January 12, 2010 – Merz has licensed an innovative drug development program and related technology originated by Acumen Pharmaceuticals, Inc. The license provides Merz certain exclusive global drug development, manufacturing and marketing rights in exchange for upfront and milestone payments to Acumen as well as royalties on future product sales. The drug technology is based on Acumen’s pioneering work on the toxic ß-amyloid protein species appearing very early in dementia of the Alzheimer’s type.


As such, the technology holds great potential in the present quest for a disease-modifying Alzheimer treatment, interfering with the cause, not just the symptoms of one of the most devastating diseases. The development of such an innovative and promising approach therefore complements the successful track record established by Merz’ current anti dementia blockbuster drug, Memantine... [PDF] Acumen Pharmaceuticals' Press Release -

Daiichi Sankyo : Approval Application in Japan for Manufacturing and Marketing of SUN Y7017 (Memantine) for the Treatment of Alzheimer’s Type Dementia

February 8, 2010 – Daiichi Sankyo Company, Limited, announced that its subsidiary, ASUBIO PHARMA CO., LTD. , submitted a New Drug Application in Japan for the manufacturing and marketing of SUN Y7017 (generic name: Memantine hydrocholoride), which was developed for the treatment of Alzheimer’s type Dementia (AD).SUN Y7017 is an N-methyl-D-aspartate (NMDA) receptor antagonist developed by Merz Pharmaceuticals GmbH... [PDF] Daiichi Sankyo's Press Release -