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News : Innovation Last Updated: Aug 7, 2012 - 4:51 PM


Alzheimer's drug trials ended by Pfizer and Johnson & Johnson; Elan to book charge
By Finfacts Team
Aug 7, 2012 - 3:13 PM

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Two US drug makers on Monday announced they will stop development of an Alzheimer's drug because it failed in two late-stage clinical trials. Bapineuzumab, made by Pfizer and Johnson & Johnson, was designed to halt build-up of plaque in the brain. However it  failed to improve cognitive or functional performance compared with a placebo in certain patients. Elan, the Irish headquartered drugs company, had a stake in the development.

"We are tremendously disappointed for patients and their caregivers who are suffering from Alzheimer’s and our employees who have dedicated many years to advancing this technology with the goal of creating a meaningful therapy to combat this challenging disease,” said Kelly Martin, CEO of Elan Corporation, plc. He commented further that, “from a shareholder perspective, we will continue to focus on revenue growth with the advancement of Tysabri (a treatment for multiple sclerosis: MS), rigorous cost and timeline alignment and  - - as we have done consistently over the years - - - a strengthening of our balance sheet and capital structure to provide a unique growth and value investment thesis to the marketplace while continuously reducing overall financial risk.”

Elan said it will record a non-cash impairment charge of $117.3m on its equity method investment in Janssen AI, a unit of J&J, in the third quarter of 2012, representing the full carrying value of Elan’s 49.9% proportionate share of the Janssen AI AIP assets. J&J said it would take a charge of $300m to $400m in the third quarter.

Elan's share price was down 13% in Dublin at 1500.

In September 2009, as a result of its transaction with Johnson & Johnson, Elan acquired a 49.9% interest in Janssen AI. Janssen AI partners with Pfizer, Inc on all operational aspects of the immunotherapeutic platform including Bapineuzumab. Elan owns 25% of the AIP asset on a global basis plus certain royalty streams at various revenue levels should any therapy from AIP be commercialised in the future.

Pfizer and Johnson & Johnson had announced on 23 July that the first clinical trial of the intravenous (IV) version of Bapineuzumab had failed. In the trial, patients with a gene that is associated with a greater risk of Alzheimer's were tested. However, the results with the group were largely the same as with those who did not have the gene, who were tested in the second study.

"One of the strong thoughts in the field is that you really have to treat people before they become demented," William Thies, chief scientific officer of the Alzheimer's Association told Reuters, adding that the announcement did not prevent the drug from being tested as a preventative.

And he added that despite the trial's failure, data from the experiment could still be useful.

"These studies are terribly important for us to learn about Alzheimer's disease, and that part of the process is just starting as the data continues to be crunched in a variety of ways."

The Wall Street Journal; said that Bapineuzumab aimed to attack a sticky substance that builds up in the brains of Alzheimer's patients. While the drug appeared to succeed at removing these so-called amyloid plaques, the trial results suggest that wasn't enough to provide a therapeutic benefit, at least in patients who have had the disease for long enough to be classified as mild or moderate.

"Targeting amyloid we still believe is very important. The main question is going to be how early do you need to do that" and how to identify patients soon enough, said Husseini Manji, who heads neuroscience research at J&J. He called the results "a terrific disappointment and a setback," but said lessons could be learned that would drive further drug R&D.

The Journal said the drug makers have invested hundreds of millions of dollars trying to find a safe, effective treatment for Alzheimer's. If successful, they could have tapped into a market that analysts estimate could exceed $10 billion a year, up from $3 billion a year currently.

A similar drug being developed by Eli Lilly, Solanezumab, is also considered a long-shot to succeed, but results of the trials will not be available until later this year.

Pfizer said Alzheimer’s disease, the most common form of dementia, is a degenerative brain disease that is not a normal part of ageing. Currently there is neither a cure nor a treatment that delays the course of Alzheimer’s disease, which gradually destroys a person’s cognitive and functional abilities, including memory and the ability to perform activities of daily living, such as bathing and eating. Alzheimer’s disease is the sixth leading cause of death in the United States, estimated to affect more than five million people. It is estimated that there were 35.6m people with dementia, including Alzheimer’s disease, worldwide in 2010. This number is projected to nearly double every 20 years, increasing to 65.7m in 2030 and 115.4m in 2050 worldwide. Furthermore, the total worldwide costs of dementia, including Alzheimer's disease, were estimated around one percent of global gross domestic product (GDP) in 2010, at more than US$600bn. This includes costs attributed to informal unpaid care, community or residential-based care and treatment.

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