Indeks
July 24-- Wyeth's experimental Alzheimer's drug has shown promise as a way to attack the mind-robbing disease affecting 18 million people worldwide. Side-effects may yet derail the medicine.
Wyeth said last month that the drug, called bapineuzumab, slowed memory loss in a portion of test patients, sending the shares up 10 percent. Investors hoping for a drug that has potential sales of $5 billion a year should be wary because the company didn't release safety data or specify how well the treatment worked, said Caris & Co. analyst David Moskowitz.
Wyeth needs the drug to replace earnings from its heartburn pill Protonix and antidepressant Effexor, which generate a quarter of revenue and face generic competition in two years. While the Alzheimer's treatment works in a novel manner, a similar drug developed by Wyeth, and another by Myriad Genetics Inc., already failed in tests this year. There's a ``50-50'' chance bapineuzumab will share that fate, Moskowitz said.
``All we've seen is a press release that states the drug succeeded in a subpopulation,'' Moskowitz, based in Vienna, Virginia, said in a telephone interview. He lowered his rating on the stock to ``average'' from ``above average,'' on July 8 and warned clients that ``a successful launch of bapineuzumab is currently being factored in the shares.''
Share Reaction
Wyeth, based in Madison, New Jersey, fell 74 cents, or 1.6 percent, to $44.81 at 4 p.m. in New York Stock Exchange composite trading. The company has dropped 11 percent in the last 12 months as four experimental drugs were delayed by the U.S. Food & Drug Administration.
Elan Corp., which works on the drug with Wyeth, fell 1.95 euros, or 8.8 percent, to 20.12 euros in Dublin trading. The stock has gained 38 percent in the last year.
Wyeth says it has more than 350 scientists working on Alzheimer's and has spent more than $500 million on it since 2001. The number of people with Alzheimer's will almost double to 34 million in 2025, according to the World Health Organization in Geneva, Switzerland.
Wyeth and Dublin-based Elan Corp. equally share the profits and expenses of bapineuzumab, according to Cowan & Co. analyst Steven Scala. Full results of the study released last month will be reported at the International Conference on Alzheimer's Disease, or ICAD, in Chicago on July 29.
Elan and Wyeth are racing Eli Lilly & Co. to develop the first drugs that work by reducing the buildup of a protein, known as beta amyloid, found in the brains of Alzheimer's patients. Indianapolis-based Lilly also will present results from patient test at ICAD, the day after Wyeth does.
Risky Approach
The approach is a gamble, as tests have yet to show that preventing or removing amyloid plaque will slow Alzheimer's. Salt Lake City-based Myriad Genetics Inc. failed with a similar drug in June, and an experimental vaccine made by Wyeth and Elan reduced plaque while failing to stave off Alzheimer's in a study reported last week.
``Questions about side effects haven't been answered yet,'' said David Heupel, who helps manage $60 billion at Minneapolis- based Thrivent Financial for Lutherans, in a telephone interview. ``We can't definitively say it's going to work and it's safe. It's going to be several years before we have that answer.''
Bapineuzumab didn't show a statistically valid benefit for patients under the original design of the study, Wyeth said when it announced preliminary results last month. A further analysis found that patients who don't carry a gene called ApoE4, and make up about half those with the disease, did respond to the drug.
Brain Swelling
The patients who have ApoE4, and didn't benefit from the treatment, also were more likely to have side effects, among them vasogenic edema, a potentially fatal buildup of fluid in the brain. That condition occurred most often with higher doses of the drug, Wyeth said.
Elan and Wyeth didn't say if the group of test patients who improved with the drug also had cases of the brain-swelling condition.
``That will be the real area of importance,'' Moskowitz said. ``We might find that the vasogenic edema, which is a serious side effect, did occur in the non-carrier group.''
Wyeth spokesman Michael Lampe declined to comment on the side effects in the non-carrier group before the conference. Final testing before seeking regulatory approval includes four tests, two in the U.S. and two worldwide, he said. Patients without the gene will be tested at four dose levels, while patients who have ApoE4 will only be given the lowest dose.
``We've said previously that the phase 2 data may inform some of the parameters of the phase 3 study, but there have been no changes thus far,'' Lampe said in a telephone interview.
Alleviating Symptoms
Current drugs on the market, with $5 billion in yearly sales, alleviate symptoms without attacking the disease. Pfizer Inc.'s treatment, Aricept, slows the mind's decline for an average of six to 12 months in about half the patients who take it. Forest Laboratories Inc.'s Namenda, Novartis AG's Exelon and Johnson & Johnson's Razadyne are similarly short-lived, focusing on stimulating brain signals instead of stopping plaque buildup.
Pfizer and Forest are based in New York, Novartis is in Basel, Switzerland and J&J is in New Brunswick, New Jersey.
Heupel said the drug has a 50 percent chance of being approved and could bring in as much as $10 billion in yearly sales. Goldman Sachs analyst James Kelly, who has ``neutral'' rating on the stock and a $50 price target, estimates a 60 percent chance of approval in 2011 and five-year sales of more than $5 billion. Seven analysts surveyed by Bloomberg recommend buying Wyeth, while ten have neutral ratings.
``Clearly, bapineuzumab could change the outlook for patients and the growth trajectory of the company if the drug were approved,'' Linda Bannister, an analyst at Edward Jones & Co. in Des Peres, Missouri, said in a telephone interview. ``We believe it will be.''
Wyeth said last month that the drug, called bapineuzumab, slowed memory loss in a portion of test patients, sending the shares up 10 percent. Investors hoping for a drug that has potential sales of $5 billion a year should be wary because the company didn't release safety data or specify how well the treatment worked, said Caris & Co. analyst David Moskowitz.
Wyeth needs the drug to replace earnings from its heartburn pill Protonix and antidepressant Effexor, which generate a quarter of revenue and face generic competition in two years. While the Alzheimer's treatment works in a novel manner, a similar drug developed by Wyeth, and another by Myriad Genetics Inc., already failed in tests this year. There's a ``50-50'' chance bapineuzumab will share that fate, Moskowitz said.
``All we've seen is a press release that states the drug succeeded in a subpopulation,'' Moskowitz, based in Vienna, Virginia, said in a telephone interview. He lowered his rating on the stock to ``average'' from ``above average,'' on July 8 and warned clients that ``a successful launch of bapineuzumab is currently being factored in the shares.''
Share Reaction
Wyeth, based in Madison, New Jersey, fell 74 cents, or 1.6 percent, to $44.81 at 4 p.m. in New York Stock Exchange composite trading. The company has dropped 11 percent in the last 12 months as four experimental drugs were delayed by the U.S. Food & Drug Administration.
Elan Corp., which works on the drug with Wyeth, fell 1.95 euros, or 8.8 percent, to 20.12 euros in Dublin trading. The stock has gained 38 percent in the last year.
Wyeth says it has more than 350 scientists working on Alzheimer's and has spent more than $500 million on it since 2001. The number of people with Alzheimer's will almost double to 34 million in 2025, according to the World Health Organization in Geneva, Switzerland.
Wyeth and Dublin-based Elan Corp. equally share the profits and expenses of bapineuzumab, according to Cowan & Co. analyst Steven Scala. Full results of the study released last month will be reported at the International Conference on Alzheimer's Disease, or ICAD, in Chicago on July 29.
Elan and Wyeth are racing Eli Lilly & Co. to develop the first drugs that work by reducing the buildup of a protein, known as beta amyloid, found in the brains of Alzheimer's patients. Indianapolis-based Lilly also will present results from patient test at ICAD, the day after Wyeth does.
Risky Approach
The approach is a gamble, as tests have yet to show that preventing or removing amyloid plaque will slow Alzheimer's. Salt Lake City-based Myriad Genetics Inc. failed with a similar drug in June, and an experimental vaccine made by Wyeth and Elan reduced plaque while failing to stave off Alzheimer's in a study reported last week.
``Questions about side effects haven't been answered yet,'' said David Heupel, who helps manage $60 billion at Minneapolis- based Thrivent Financial for Lutherans, in a telephone interview. ``We can't definitively say it's going to work and it's safe. It's going to be several years before we have that answer.''
Bapineuzumab didn't show a statistically valid benefit for patients under the original design of the study, Wyeth said when it announced preliminary results last month. A further analysis found that patients who don't carry a gene called ApoE4, and make up about half those with the disease, did respond to the drug.
Brain Swelling
The patients who have ApoE4, and didn't benefit from the treatment, also were more likely to have side effects, among them vasogenic edema, a potentially fatal buildup of fluid in the brain. That condition occurred most often with higher doses of the drug, Wyeth said.
Elan and Wyeth didn't say if the group of test patients who improved with the drug also had cases of the brain-swelling condition.
``That will be the real area of importance,'' Moskowitz said. ``We might find that the vasogenic edema, which is a serious side effect, did occur in the non-carrier group.''
Wyeth spokesman Michael Lampe declined to comment on the side effects in the non-carrier group before the conference. Final testing before seeking regulatory approval includes four tests, two in the U.S. and two worldwide, he said. Patients without the gene will be tested at four dose levels, while patients who have ApoE4 will only be given the lowest dose.
``We've said previously that the phase 2 data may inform some of the parameters of the phase 3 study, but there have been no changes thus far,'' Lampe said in a telephone interview.
Alleviating Symptoms
Current drugs on the market, with $5 billion in yearly sales, alleviate symptoms without attacking the disease. Pfizer Inc.'s treatment, Aricept, slows the mind's decline for an average of six to 12 months in about half the patients who take it. Forest Laboratories Inc.'s Namenda, Novartis AG's Exelon and Johnson & Johnson's Razadyne are similarly short-lived, focusing on stimulating brain signals instead of stopping plaque buildup.
Pfizer and Forest are based in New York, Novartis is in Basel, Switzerland and J&J is in New Brunswick, New Jersey.
Heupel said the drug has a 50 percent chance of being approved and could bring in as much as $10 billion in yearly sales. Goldman Sachs analyst James Kelly, who has ``neutral'' rating on the stock and a $50 price target, estimates a 60 percent chance of approval in 2011 and five-year sales of more than $5 billion. Seven analysts surveyed by Bloomberg recommend buying Wyeth, while ten have neutral ratings.
``Clearly, bapineuzumab could change the outlook for patients and the growth trajectory of the company if the drug were approved,'' Linda Bannister, an analyst at Edward Jones & Co. in Des Peres, Missouri, said in a telephone interview. ``We believe it will be.''
