Tweet
Elan continues its bid for Alzheimer's breakthrough
16 January 2005 By Eamon Quinn
When The Sunday Business Post last interviewed Lars Ekman, Elan's head of research and development, in late 2003, the company's shares were trading at $5 in New York and its breakthrough drug Tysabri - then called Antegren - was still some time away from clinching its fast-tracked regulatory approval in the US for the treatment of multiple sclerosis (MS).
But even then, as he spoke on the fringes of an Elan shareholders' meeting in Dublin, the San Diego-based Ekman showed unusual confidence about the prospects for Tysabri. The senior scientist enthused about the likely outcome of the phase II trials the drug was then undergoing.
Fifteen months later the chief chemist's confidence had been vindicated. Last week Elan shares - the most hotly speculated stock in Ireland during 2004 - traded at $28.55 after an extraordinary two months in which Elan has won approval and started production of the MS drug with Biogen, its co-developer of the potential wonder drug. Elan, which not so long ago had faced collapse under its $1 billion debt mountain, had also by late last year settled with the US Securities and Exchange Commission on its controversial accounting for its investment vehicles.
Last week, talking to this newspaper, Ekman's enthusiasm had dimmed little. This time he was talking about the prospects of extending Tysabri for the treatment Crohn's disease and rheumatoid arthritis and about the outlook for Prialt, the pain management drug that has recently been approved by US regulators.
But more significantly, Elan's R&D president was also looking forward to the prospects this year for Elan's clinical tests on Alzheimer's with a separate treatment.
Alzheimer's treatment is the blockbuster that the global drug industry is chasing. In market terms, it towers above MS, Crohn's and related diseases.
In recent weeks, Elan has been telling the investment community that it was not a one-trick pony, and that Tysabri has the potential to tackle a large range of diseases.
But for Ekman, Alzheimer's research, with its separate treatment, remains at the heart of Elan's mission. For investors who lost money in Elan four years ago, and for those who failed to profit from Elan's fourfold stock surge last year, talk that Alzheimer's could be the big new story for the drug company in 2005 will have an unsettling and familiar ring.
Investors lost a lot of money when Elan shares imploded with the news that its original Alzheimer's research had failed. The company abandoned clinical trials, which it had started in the US in 1999, when patients who had taken the original drug showed initial extreme side-effects, including inflammation of brain tissue.
Nonetheless, Ekman, who had worked for Schwarz Pharma before joining Elan in 2001, said it was the prospect of Elan delivering a breakthrough treatment for Alzheimer's that persuaded him to give up a well-paid and secure job four years ago.
The talk at a JP Morgan conference in California last week was very much focused on Tysabri. “People are very excited about what we have accomplished, and the feedback is very positive,” Ekman said in a telephone interview. But the R&D president was still looking forward to the prospects for Alzheimer's research.
“The first drug we had was AN1792.What happened was that in phase II we had a small number of patients who had a transitory inflammation of the brain - they had it for 10 days, and then it went away.
“Because of that, we decided not to continue to dose patients. We decided it was not worth the risk,’' Ekman said.
“What the market did not understand is that we continued to monitor those patients, and what we found was that they had an improved quality of life and brain function. We got what is called the ‘truth of principle' for the drug, and what we had to find was a safer mechanism.”
Elan and pharmaceutical giant Wyeth are betting that their newAAB-001 is that safer drug. The antibody treatment has been in clinical trials for 18 months, and no side effects have been reported.
Additional data from the trials will be published in the next three months, potentially bringing investor focus back to Elan's work on Alzheimer's this year.
The company plans to start testing 180 patients with AAB-001 in trials in the US this year. A small trial is also planned for Britain and Finland, with 30 patients. This will get under way in the next three months.
Ekman said that the purpose of the study was to monitor beta amyloid, the toxic substance which creates Alzheimer's and can kill nerve cells, and to quantify with brain imagery the impact on memory and memory functionality of patients. He claims that the Elan and Wyeth approach is unique.
“The purpose is to reverse the disease,” said Ekman.
“There is no drug which is a so-called disease modifier.
“There are a number which have started trials, but there is no rival which is a disease modifier.”
Current drugs are disease inhibitors, which increase the number of transmitters in the brain, according to Ekman.
“In this, Elan and Wyeth are clearly leading the race in immune therapy approach to Alzheimer's.”
Elan hopes to bring the drug to market by 2008-2009.
But if the trials were to be successful the effect on Elan shares would be felt well before that date.
Alzheimer's is a huge market. Eight million sufferers are already diagnosed in the US and Europe. An ageing western population is likely to bring the number of sufferers to 20 million in 10 years, according to industry estimates.
“Since July, no further data has been put in the public domain. We have not yet disclosed the data,” said Ekman.
Asked whether the AAB-001 trials were proceeding successfully, he said that the data would probably be published at the later part of this year.
“We are still cautiously optimistic that we will have a major impact on patients with Alzheimer's disease,” Ekman said.
Before that, Elan investors will have plenty to follow in the roll-out of Tsyabri. Elan hopes to file for approval in the US with Tysabri for Crohn's disease, the inflammatory disease of the intestine.
Elan claims it will have fewer side effects than the existing treatment, Remicade.
The drug could be used to treat ulcerative colitis, a sister disease of Crohn's, with 800,000 sufferers.
Ekman is also planning a big “robust'‘ trial using Tysabri for the treatment of rheumatoid arthritis. A phase II trial of 250 patients will start this year, and the company hopes that this will lead to filing for the drug's approval for arthritis in 2007
“The story with Tysabri has just started,’' Ekman said.
Analysts believe that Elan shares have further to rise as Elan and Biogen quantify the amount of revenues as Tysabri is rolled out.
“We won't get a handle on that until the next few months,” said Ian Hunter at Goodbody Stockbrokers.
Hunter last moved his 52-week target for the shares last November and has predicted the shares will reach $33.40 by late this year.
“We are not going to see the same level of appreciation as 2004,” he said. “You will see solid growth as Tysabri proceeds into the market for MS and as it gets approval for Crohn's.”
On the prospects for Alzheimer's, Hunter said that research into the disease was “much more emotive'‘ for investors, and that any news tended to see the share price move.
Alzheimer's research is much bigger, with about 75 drug treatments in research, compared with only 25 potential treatments being explored for MS.
“Everyone is trying to get something for Alzheimer's,” said Hunter.
16 January 2005 By Eamon Quinn
When The Sunday Business Post last interviewed Lars Ekman, Elan's head of research and development, in late 2003, the company's shares were trading at $5 in New York and its breakthrough drug Tysabri - then called Antegren - was still some time away from clinching its fast-tracked regulatory approval in the US for the treatment of multiple sclerosis (MS).
But even then, as he spoke on the fringes of an Elan shareholders' meeting in Dublin, the San Diego-based Ekman showed unusual confidence about the prospects for Tysabri. The senior scientist enthused about the likely outcome of the phase II trials the drug was then undergoing.
Fifteen months later the chief chemist's confidence had been vindicated. Last week Elan shares - the most hotly speculated stock in Ireland during 2004 - traded at $28.55 after an extraordinary two months in which Elan has won approval and started production of the MS drug with Biogen, its co-developer of the potential wonder drug. Elan, which not so long ago had faced collapse under its $1 billion debt mountain, had also by late last year settled with the US Securities and Exchange Commission on its controversial accounting for its investment vehicles.
Last week, talking to this newspaper, Ekman's enthusiasm had dimmed little. This time he was talking about the prospects of extending Tysabri for the treatment Crohn's disease and rheumatoid arthritis and about the outlook for Prialt, the pain management drug that has recently been approved by US regulators.
But more significantly, Elan's R&D president was also looking forward to the prospects this year for Elan's clinical tests on Alzheimer's with a separate treatment.
Alzheimer's treatment is the blockbuster that the global drug industry is chasing. In market terms, it towers above MS, Crohn's and related diseases.
In recent weeks, Elan has been telling the investment community that it was not a one-trick pony, and that Tysabri has the potential to tackle a large range of diseases.
But for Ekman, Alzheimer's research, with its separate treatment, remains at the heart of Elan's mission. For investors who lost money in Elan four years ago, and for those who failed to profit from Elan's fourfold stock surge last year, talk that Alzheimer's could be the big new story for the drug company in 2005 will have an unsettling and familiar ring.
Investors lost a lot of money when Elan shares imploded with the news that its original Alzheimer's research had failed. The company abandoned clinical trials, which it had started in the US in 1999, when patients who had taken the original drug showed initial extreme side-effects, including inflammation of brain tissue.
Nonetheless, Ekman, who had worked for Schwarz Pharma before joining Elan in 2001, said it was the prospect of Elan delivering a breakthrough treatment for Alzheimer's that persuaded him to give up a well-paid and secure job four years ago.
The talk at a JP Morgan conference in California last week was very much focused on Tysabri. “People are very excited about what we have accomplished, and the feedback is very positive,” Ekman said in a telephone interview. But the R&D president was still looking forward to the prospects for Alzheimer's research.
“The first drug we had was AN1792.What happened was that in phase II we had a small number of patients who had a transitory inflammation of the brain - they had it for 10 days, and then it went away.
“Because of that, we decided not to continue to dose patients. We decided it was not worth the risk,’' Ekman said.
“What the market did not understand is that we continued to monitor those patients, and what we found was that they had an improved quality of life and brain function. We got what is called the ‘truth of principle' for the drug, and what we had to find was a safer mechanism.”
Elan and pharmaceutical giant Wyeth are betting that their newAAB-001 is that safer drug. The antibody treatment has been in clinical trials for 18 months, and no side effects have been reported.
Additional data from the trials will be published in the next three months, potentially bringing investor focus back to Elan's work on Alzheimer's this year.
The company plans to start testing 180 patients with AAB-001 in trials in the US this year. A small trial is also planned for Britain and Finland, with 30 patients. This will get under way in the next three months.
Ekman said that the purpose of the study was to monitor beta amyloid, the toxic substance which creates Alzheimer's and can kill nerve cells, and to quantify with brain imagery the impact on memory and memory functionality of patients. He claims that the Elan and Wyeth approach is unique.
“The purpose is to reverse the disease,” said Ekman.
“There is no drug which is a so-called disease modifier.
“There are a number which have started trials, but there is no rival which is a disease modifier.”
Current drugs are disease inhibitors, which increase the number of transmitters in the brain, according to Ekman.
“In this, Elan and Wyeth are clearly leading the race in immune therapy approach to Alzheimer's.”
Elan hopes to bring the drug to market by 2008-2009.
But if the trials were to be successful the effect on Elan shares would be felt well before that date.
Alzheimer's is a huge market. Eight million sufferers are already diagnosed in the US and Europe. An ageing western population is likely to bring the number of sufferers to 20 million in 10 years, according to industry estimates.
“Since July, no further data has been put in the public domain. We have not yet disclosed the data,” said Ekman.
Asked whether the AAB-001 trials were proceeding successfully, he said that the data would probably be published at the later part of this year.
“We are still cautiously optimistic that we will have a major impact on patients with Alzheimer's disease,” Ekman said.
Before that, Elan investors will have plenty to follow in the roll-out of Tsyabri. Elan hopes to file for approval in the US with Tysabri for Crohn's disease, the inflammatory disease of the intestine.
Elan claims it will have fewer side effects than the existing treatment, Remicade.
The drug could be used to treat ulcerative colitis, a sister disease of Crohn's, with 800,000 sufferers.
Ekman is also planning a big “robust'‘ trial using Tysabri for the treatment of rheumatoid arthritis. A phase II trial of 250 patients will start this year, and the company hopes that this will lead to filing for the drug's approval for arthritis in 2007
“The story with Tysabri has just started,’' Ekman said.
Analysts believe that Elan shares have further to rise as Elan and Biogen quantify the amount of revenues as Tysabri is rolled out.
“We won't get a handle on that until the next few months,” said Ian Hunter at Goodbody Stockbrokers.
Hunter last moved his 52-week target for the shares last November and has predicted the shares will reach $33.40 by late this year.
“We are not going to see the same level of appreciation as 2004,” he said. “You will see solid growth as Tysabri proceeds into the market for MS and as it gets approval for Crohn's.”
On the prospects for Alzheimer's, Hunter said that research into the disease was “much more emotive'‘ for investors, and that any news tended to see the share price move.
Alzheimer's research is much bigger, with about 75 drug treatments in research, compared with only 25 potential treatments being explored for MS.
“Everyone is trying to get something for Alzheimer's,” said Hunter.