Analyst Outlook
Namenda’s (memantine; Allergan/Lundbeck/Daiichi Sankyo) global sales have peaked at approximately
$2.3bn in 2014, making it the current leader in the Alzheimer’s disease market. Namenda has grown
as a successful brand as a result of its novel mode of action and positioning as an add-on therapy for
patients with moderate to severe Alzheimer’s disease. However, with the onset of generic erosion and
successful reformulations of competitor products targeting the severe Alzheimer’s disease market,
Namenda will be unable to continue its sales growth. Allergan’s lifecycle management strategy – the
launches of Namenda XR and Namzaric – will likely lessen sales erosion in the US, but will be unable
to prevent the inevitable decline in sales that accompanies patent expiries.
Drug Overview
Namenda is a first in-class, N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the
treatment of moderate to severe Alzheimer’s disease. It is a voltage-dependent uncompetitive
antagonist, with low to moderate affinity to the NMDA receptor. By blocking the activity of the
NMDA receptor, it decreases glutamate-induced prolonged calcium influx, thereby limiting the
occurrence of neurotoxicity and cell death, which are underlying pathologies in Alzheimer’s disease
(Actavis, 2003; FDA, 2014a; Parsons et al., 2013). This alternative mode of action has enabled the drug
to find use as an adjunctive to cholinesterase inhibitors.
Memantine was first launched by Merz in Germany in 1982, although it was not until December 2002
that it was more widely commercialized in the EU by Lundbeck, under the brand name Ebixa (EMA,
2015). Forest Laboratories, now part of Allergan, subsequently launched the drug in the US in January
2004 under the brand name Namenda (Pharmaprojects, 2015; Allergan, 2014). In both regions,
Namenda is approved for moderate to severe Alzheimer’s disease. Furthermore, Merz’s commercial
partner for memantine in Japan, Daiichi Sankyo, launched the product for moderate to severe
Alzheimer’s disease under the brand name Memary in June 2011 (Daiichi Sankyo, 2011). Lundbeck and
Allergan also filed for an extension of Namenda’s label to include patients with mild to moderate
Alzheimer’s disease, although the company’s applications to the European Medicines Agency and the
US Food and Drug Administration (FDA) were ultimately unsuccessful (Biomedtracker, 2015).
Namenda is available in 5mg and 10mg tablets, to be taken twice daily. Given that the US product
patent expired in October 2015, Allergan pre-emptively launched Namenda XR in June 2013, a 28mg
once-daily extended-release tablet. Allergan has also developed a fixed-dose combination (FDC) of
Namenda XR with donepezil, marketed as Namzaric, in collaboration with Adamas Pharmaceuticals.
This co-formulation was approved in the US in December 2014 (Biomedtracker, 2015; Medtrack,
2015).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Namenda : Alzheimer’s disease
LIST OF FIGURES
8 Figure 1: Namenda for Alzheimer’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Namenda in Alzheimer’s
disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Namenda in Alzheimer’s
disease
LIST OF TABLES
4 Table 1: Namenda drug profile
6 Table 2: Namenda pivotal trial data in Alzheimer’s disease
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Sign up to the Pharma Intelligence Report Store Newsletter to get the latest blogs, news, reports and discounts!