Friday, April 25, 2008

Wyeth (WYE): Speculative play on Alzheimer's

Wyeth (WYE): Speculative play on Alzheimer's
Posted Apr 23rd 2008 12:36PM by Steven Halpern

Regarding his latest new buy recommendation -- Wyeth (NYSEL WYE) -- biotech expert Michael Shulman states, "OK, I know what you're thinking. Wyeth?! It's a lousy big pharma with a stock price that's down 12% in the past 10 years."

Nevertheless, in his ChangeWave Biotech Investor he explains, "I like Wyeth for two very good reasons: It's a great play for the current market, and it's a good speculative play on disease breakthroughs."

"Believe it or not, WYE is a cash-rich big pharma selling below its potential breakup value and it has a very good Alzheimer's disease treatment in its pipeline. The Alzheimer's treatment is the primary reason for this recommendation.

"I've written extensively about Alzheimer's and I've kept an eye on this particular Wyeth drug and the potential it has for success.

"The Wyeth drug in question is a genetically engineered antibody called bapineuzumab. It's the second formulation of a 'vaccine' that showed dramatic improvements in cognition and reduction in brain plaques (as determined by autopsy) in its original formula.


"Unfortunately the first formulation also generated encephalitis (brain swelling) in a meaningful number of patients and the trial was suspended.

"The second-generation product is a passive, versus active, vaccine. It doesn't trigger the aggressive immune response from the body that was the cause, Wyeth believes, of the encephalitis.

"The early Phase II results haven't been published, but they must have been great because the company is already going ahead with a very expensive Phase III trial with 4,100 patients.

"Meanwhile, Wyeth has major marketplace winners such as Enbrel, a $5-billion drug for arthritis and psoriasis, and anti-depressant Effexor with $4 billion in sales. The company also has $3 billion in sales of consumer products such as Advil and Preparation H.

"The company has $22 billion in sales; $3.40-$3.60 in profits per share, giving it a P/E of 3; a 2.5% dividend; more cash than debt; and 72% gross profit margins. It is everything you would expect a big pharma outfit to be -- but up to one-third of revenues now come from biotech products such as Enbrel.

"Make no mistake, however. As far as I'm concerned this investment recommendation is about one drug: bapineuzumab. At this point I believe the possibilities for bapineuzumab (let alone the rest of the pipeline) are not really factored into the stock price.

"If bapineuzumab fails in trial, the stock will take a modest hit -- maybe a few of points -- and if WYE posts strong results in June it will start a stock run that could push it back to the mid-$60s. Anyway we look at it that's a very good risk/reward ratio for a recession-proof, cash-rich company."

Each day, Steven Halpern's TheStockAdvisors.com offers the latest market commentary and favorite investment ideas from the nation's leading financial newsletter advisors.

Tuesday, April 08, 2008

Irish newspaper talks about Elan & Wyeth drug

Alzheimer's prediction helps Elan jump 6pc
By Ailish O'Hora
Tuesday April 08 2008
http://www.independent.ie/business/irish/alzheimers-prediction-helps-elan-jump-6pc-1341260.html


Shares in Elan finished yesterday up over 6pc at €14.72 on the back of estimates that an Alzheimer's treatment co-developed by the Irish drugmaker and international giant Wyeth could notch up sales of over $13bn and surpass Pfizer's cholesterol treatment Lipitor to become the biggest drug of all-time.

According to a report in the influential Wall Street publication Barron's, healthcare investor Larry Feinberg, whose flagship healthcare hedge fund Oracle Investment Management has averaged 21pc over the past 18 years, said that the effect on Wyeth's shares could be a 50pc increase over the next year.

In early 2002, Wyeth was forced to halt an Alzheimer's vaccine trial after 18 out of 300 patients developed encephalitis. But the report stated that the two companies are sponsoring research aimed at neutralising the adverse reaction.

Wyeth researchers believe that what caused the brain swelling was the use of an "active" inoculation that mobilises the body's immune system to produce antibodies. So in 2005, they began testing a "passive" vaccine that supplies antibodies directly to fight senile plaques in the brain -- a characteristic feature of Alzheimer's Disease.

The US Federal Drug Administration (FDA) fast-tracked the study after patients seemed to show signs of mental improvement from even moderate doses of the drug. Results of the Phase II trial on 240 patients are due in June and there is also an ongoing Phase III trial, involving 4,100 people and costing an estimated $300m -- although it will probably be years before the treatment is fully tested and reviewed by regulators. Other biotechnology companies are also testing Alzheimer's treatments.

Elan is probably more famous for its multiple sclerosis treatment Tysabri which is also used to treat Crohn's disease.

Shares in Elan tumbled back in February when it emerged that Tysabri could cause significant liver damage in patients.

At the time, the US regulator, the Food and Drug Administration (FDA) announced that Elan and its US partner Biogen Idec had written to doctors to warn them of the danger.

Tysabri was taken off the market in 2005 shortly after its initial launch after three cases of a potentially fatal brain infection known as progressive multifocal leukoencephalopathy emerged.

The drug returned to the market in 2006 with limits after the FDA decided MS patients were willing to accept the risks in light of possible benefits.

- Ailish O'Hora

Wyeth and Elan Trade on CNBC fastmoney April 7th 2008

Wyeth and Elan Trade
Both stocks of Wyeth (WYE) and Elan (ELN) spiked on Monday after news broke of a new Alzheimer's drug. Kris Jenner, M.D., lead portfolio manager at T. Rowe Price Health Science Fund joined the "Fast Money" crew to discuss his take on the news. Jenner explained that the drug AAB-001 could be the most advanced drug for Alzheimer's and information will come out over the next 3 months that will lead to the probability of the drug succeeding in phase 3 trials. He went on to explain that drug could be a blockbuster with a market of 7 million Alzheimer's patients in the U.S and Western Europe and the costs for the therapy at $10,000 a year. Jenner said the chances are 50/50 the drug will be approved. The companies that could benefit from the news are Elan (ELN) and Wyeth (WYE) with Elan having the biggest potential upside. Najarian advised investors to look at Myriad (MYGN) and Eli Lilly (LLY), which also have Alzheimer's drugs in their pipelines

Monday, April 07, 2008

Alzheimer's Miracle? CNBC fast money crew talks about Elan

Alzheimer's Miracle?
Posted By:Lee Brodie
Topics:Stock Market | Stock Picks
Sectors:Pharmaceuticals
Companies:Eli Lilly and Company | Myriad Genetics Inc | Wyeth | Elan Corporation, plc


click here to watch the video
Shares of Wyeth and Elan surged Monday on the promise of a new Alzheimer's drug.

Kris Jenner, M.D., lead portfolio manager for the T. Rowe Price Health Sciences Fund joins the panel for this conversation. Following is a summary of his main points.

Tell us about the drug.

AAB-001 is probably the most advanced product for Alzheimer’s, Jenner explains. And we’re going to get information over the next two months that will tell us about the probability of its success in Phase 3 trials.

The market is excited because there are approximately 7 million Alzheimer’s patients in the US and Western Europe. If only 1 million of those individuals get on this therapy at $10,000/ year that’s a 10 billion dollar drug!

Is it a cure?



It is not, replies Jenner. But it has the opportunity to really delay the very devastating effects. While not a cure, it could be a tremendous advance forward.

What are the odds it will make it to market?

I think the probabilities are good, replies Jenner, greater than 50/50. But we’re at a pivotal point so buyer beware. However, I think the upside here is unlike many other pharma opportunities.

Which comapny benefits most?

Elan Elan Corp PLCELN
23.17 1.50 +6.92% NYSE


Quote | Chart | News | Profile
[ELN 23.17 1.50 (+6.92%) ] will have much higher reward but also higher risk, he says. With Wyeth WyethWYE
44.3 2.74 +6.59% NYSE


Quote | Chart | News | Profile
[WYE 44.3 2.74 (+6.59%) ] you would participate but not have the same upside. We have a larger position in Elan

On a related note, Myriad Myriad Genetics IncMYGN
40.85 0.17 +0.42% NASDAQ


Quote | Chart | News | Profile
[MYGN 40.85 0.17 (+0.42%) ] and Lilly Eli Lilly and CoLLY
53.06 0.78 +1.49% NYSE


Quote | Chart | News | Profile
[LLY 53.06 0.78 (+1.49%) ] also have other Alzheimer’s drugs in the pipeline and could also be worth a look, adds Pete Najarian.

Attacking Alzheimer's Elan's Dennis Selkoe




Executive Health
Attacking Alzheimer's
Robert Langreth 04.21.08, 12:00 AM ET

Dennis Selkoe




The drug industry has bet heavily on one theory about the disease. What if that theory is wrong?
In 1906 a German psychiatrist described the puzzling case of a 56-year-old woman who had just died after years of progressive memory loss and hallucinations. An autopsy found her brain shriveled and filled with strange protein deposits. The disease, which took on the name of the psychiatrist, Alois Alzheimer, still mystifies doctors a century later. Researchers still debate its cause. And there are no treatments that stop its relentless and fatal course.

But that could be about to change. In a multibillion-dollar gamble, some of the world's biggest drug companies have begun final-stage trials of drugs that aim to slow or halt the progression of the devastating dementia. The products of over two decades of research, these drugs target the prime suspect in Alzheimer's disease, the telltale amyloid clumps spotted by the German doctor.

By clearing out those deposits or halting their production, researchers hope to slow brain cell death and alter the course of the illness. Even a drug that eased the decline only modestly could keep millions of patients out of nursing homes for years. "If we could keep people who are still functioning from having any further decline for five years--then they would probably die from something else," says Todd Golde, a neuroscientist at the Mayo Clinic, in Jacksonville, Fla. "The impact would be immeasurable."

Ultimately, doctors hope to use the disease-slowing drugs in conjunction with new brain-scanning methods being tested at General Electric (nyse: GE - news - people ) and elsewhere that will detect early signs of amyloid buildup. People with mild memory loss will get a brain scan to see if plaques are present. If they are, they'll then start the drugs right away to stop the disease in its tracks.

"Pretty much every pharmaceutical company in the world" is testing amyloid-busting drugs, says Menelas Pangalos, vice president for neuroscience research at the pharmaceutical firm Wyeth. Wyeth has spent over $500 million on Alzheimer's since 2001 and has four antiamyloid drugs in human testing. Its lead one is an antibody developed with Elan Corp. (nyse: ELN - news - people ) that has been shown to destroy 80% of the amyloid in the brains of affected mice.

Eli Lilly (nyse: LLY - news - people ) is hot on Wyeth's heels. Lilly has pursued Alzheimer's for nearly a quarter of a century. Its pill blocks an enzyme involved in amyloid production. Says Lilly's research chief, Steven Paul, "If amyloid isn't connected to the disease pathogenesis, God is playing a fairly mean trick on us." A dark horse in the race is Myriad Genetics (nasdaq: MYGN - news - people ), whose Flurizan pill aims to prevent the body from producing the most toxic form of amyloid.

But by focusing so heavily on amyloid, the drug industry is taking a big risk. Even after decades of research, the case that amyloid buildup is the main cause of the disease is hardly airtight. Studies have found that some people who die from other diseases, with no dementia, still have amyloid in their brains.

The trials "are based largely on theory and hope--and some rather considerable business considerations," says University of Southern California psychiatrist Lon Schneider, a consultant to several companies. "None of the drugs have shown evidence of efficacy yet." Geneticist John Hardy, one of the first to finger amyloid as a suspect, puts the odds at 50-50 that one of the antiamyloid drugs will work. "We are all on tenterhooks," he says.

Some researchers argue that amyloid is one of many factors in the disease and may not be the primary one for most people. "We may get rid of plaques, but it may not do anything," says John Trojanowski of the University of Pennsylvania.

Another potential culprit in the brains of Alzheimer's patients is neurofibrillary tangles. And other researchers are examining the role of a bad gene, apolipoprotein E e4. It can increase the risk of Alzheimer's disease tenfold.

Proponents of the amyloid theory "listen to each other and reinforce each other, and after a while it becomes more of a religious belief," says Zaven Khachaturian, former head of Alzheimer's research at the National Institutes of Health. He thinks companies should diversify--but until recently "if you spoke against amyloid it was like committing religious heresy."

The stakes could hardly be higher. Five million Americans suffer from Alzheimer's; the number could surge to 7.7 million by 2030. One in six women and one in ten men will get it. Existing drugs such as Aricept merely improve symptoms temporarily without slowing brain cell death. Drugs that slowed the decline would be surefire bestsellers.

Myriad will wrap up its final-stage trial any month now. Even more intensely awaited are the results of a second-stage trial of Wyeth's antibody, bapineuzumab. Both companies may reveal results this summer. Says Khachaturian, "If these trials work, it will open the floodgates. If they don't, we are back to square one."

Harvard neurologist Dennis Selkoe is a champion of the amyloid theory. A charismatic and convincing speaker, he has been touting it for two decades. "There's hardly a piece of evidence that doesn't support the idea that amyloid is the cause," he insists. "The naysayers say, 'People like you pollute the field,' and 'People are hoodwinked.' But [scientists] aren't that stupid. They vote with their test tubes, and they have put their test tubes into a huge number of experiments over this amyloid hypothesis."

Selkoe teamed up with venture capitalists in 1986 to found Athena Neurosciences, now part of Elan Corp. of Dublin, Ireland. He stayed at Harvard but serves as an Elan board member.

Elan Surges on Barron's Commentary

Elan (ELN) NewsBite - Elan Surges on Barron's Commentary
Posted on Monday, April 07, 2008 12:10 PM
Elan Corp. (ELN) opened at 22.78. So far today, the stock has hit a low of 22.35 and a high of 23.23. ELN is now trading at 22.92, up 1.25 (5.49%). The stock hit its 52 week high of 26.88 in February and set its 52 week low of 13.62 in May. ELN has been climbing for the past year. Elan shares have been soaring today after a Barron's story revealed that shares of its partner Wyeth (WYE) could rise as much as 50% if an Alzheimer's treatment that it is developing proves successful. For the moment, Wyeth and Elan are sponsoring research aimed at neutralizing the adverse reaction of the experimental vaccine. Technical indicators for the stock are bearish and steady while S&P gives ELN a neutral 3 STARS (out of 5) hold rating. If you’re looking for a hedged play on this stock, consider a July bull-put credit spread below the $15 range. ELN stock could fall up to 34.6% before expiration and this position would still be profitable. [RHF - Seven Summits Strategic Investments NewsBite]
Click Symbol For More News On: (ELN) (WYE)

Wyeth's efforts on Alzheimer's boost shares

Wyeth's efforts on Alzheimer's boost shares
by Susan Todd/The Star-Ledger
Monday April 07, 2008, 2:25 PM
Shares of Wyeth and its partner Elan got a boost today after an article in Barron's touted an experimental drug the companies are working on to treat Alzheimer's Disease.

The drug, named bapineuzumab, appears to slow the devastating effects of Alzheimer's by targeting amyloid plaques, which accumulate in the brain and detrimentally impact nerve cells in the brain. The plaque build-up results in symptoms of memory loss and difficulty performing routine tasks.

Data from a mid-stage clinical trial is expected to be released in June, but the companies are already plowing ahead with late-stage study involving 4,100 patients.

Shares of Madison-based Wyeth rose 6.3 percent, or $2.65, to $44.20 in early afternoon trading as Wall Street digested the Barron's story. Elan's stock was pulled up nearly 8 percent, or $1.71 a share, to hover around $23.38 in afternoon trading.

Wall Street's excitement reflects the huge business potential for a new Alzheimer's drug. While there are already medicines on the market that treat the disease, they treat only the symptoms. The drug Wyeth is working on would take treatment to another level. "If it works,'' Joseph Camardo, senior vice president of global medical affairs, said during a healthcare conference earlier this year, "it's going to be a huge leap.''