Elan Corporation Plc. (ELN) and partner Transition Therapeutics Inc. (TTHI) recently announced their plans to move their Alzheimer’s disease pipeline candidate ELND005 into late stage trails. The companies also reported data from a mid-stage trial on ELND005. The companies presented positive safety and tolerability data on ELND005 taken twice-daily, for about 18 months. However, the trial’s cognitive and functional co-primary endpoints failed to achieve statistical significance.
The trial (AD201) initially enrolled 351 patients with mild-to-moderate Alzheimer’s disease at about 65 sites in the US. The study included four treatment arms: placebo, 250 mg BID, 1000 mg BID and 2000 mg BID. The 1000 mg BID and 2000 mg BID trials were discontinued in December last year due to serious adverse events, including mortality.
Based on these results, Elan and Transition Therapeutics plan to move ELND005 into phase III trials, the details of which are not currently available. We believe the companies will seek to enter into a partnership deal before commencing phase III studies. The signing of a lucrative deal would bring in additional funds, which would help finance the advanced stage development of the candidate.
Potential for ELND005
ELND005 received fast track designation from the US Food and Drug Administration (FDA) in 2007 for the treatment of Alzheimer’s disease. According to the Alzheimer’s Association and Alzheimer’s Disease International, more than five million Americans have Alzheimer’s disease while more than 26 million people worldwide suffer from some form of dementia.
The Alzheimer’s disease market consists of players like Pfizer Inc. (PFE), Novartis AG (NVS), Johnson & Johnson (JNJ) and Forest Laboratories, Inc. (FRX). It is estimated that the market is currently worth more than $5 billion.
Our View
We currently have a Neutral recommendation on Elan Corporation, which is supported by a Zacks #3 Rank (‘Hold’). We are encouraged with the company’s decision to move ELND005 into advanced stages of clinical development.
Elan Corporation is currently highly dependent on Tysabri (multiple sclerosis and Crohn’s disease) for revenue generation. We remain concerned that an increase in the number of progressive multifocal leukoencephalopathy (PML) cases associated with the use of Tysabri could lead to a slowdown in the sales of the drug going forward.
ELAN CP PLC ADR (ELN): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
TRANSITN THERAP (TTHI): Free Stock Analysis Report
Zacks Investment Research
