MY PICK IS ELN

[kingofthehill]

the story of Elan just keeps getting better and better

2004-06-01
Drug offers new option for Crohn's disease

Canadian-led study shows natalizumab is safe and effective

A Canadian doctor says an experimental drug called natalizumab will help in the fight against Crohn's disease, a chronic condition in which the body's own immune system mistakenly attacks the intestines.

The Crohn's and Colitis Foundation of Canada estimates 150,000 Canadian men and women suffer from Crohn's and other forms of inflammatory bowel disease, which causes abdominal pain, diarrhea and other symptoms.

Natalizumab (brand name Antegren) blocks immune cells from leaving the bloodstream and prevents them from migrating into chronically inflamed tissue.

A Canadian-led study shows the drug is safe and effective compared with inactive (placebo) treatment.

"This drug will be a welcome addition to our armamentarium for the treatment of Crohn's disease. It's important to note the safety profile of the drug is exceedingly acceptable and well tolerated, and this was a very successful clinical trial," says Dr. Brian Feagan, a professor of medicine and epidemiology and biostatistics at the University of Western Ontario in London, Ont.

The study involved 339 adults with Crohn's disease whose symptoms had significantly decreased or almost disappeared after treatment with natalizumab in a previous trial.

They were randomly assigned to receive up to 12 additional infusions of natalizumab or placebo.

After six months, 44 to 61 per cent of the natalizumab-treated patients continued to have significantly decreased or nearly absent symptoms, compared with 26 to 29 per cent of the patients who received placebo.

In addition, the researchers found no notable differences in the rates of adverse events between the two treatment groups.

"Our current therapies (for Crohn's disease) are associated with opportunistic infections ... (but) there was no evidence that (natalizumab) therapy was associated with significant infections," Feagan says.

[kingofthehill]

From the front page of Todays Morgan Stanley report on Elan's 50/50 partner Biogen :

"Street underestimates Antegren profit contribution.
While Antegren´s significant potential is widely accepted, we believe the Street is underestimating its bottom-line contribution and potential in areas outside of MS, while overestimating the threat to the bottom-line from Avonex erosion. We estimate worldwide peak sales of Antegren of >$3billion and expect a strong launch in early 2005

[kingofthehill]

Elan filed for MS drug in Europe today ...and the good news continues


WE ARE JUST STARTING TO LIGHT THE FUSE ON THIS 5 YEAR PROJECT!!

ALZHEIMERS VACCINE...IF THEY DO GET THIS ITS LIKE THE DISCOVERY OF FIRE!

June 4, 2004 WYE/ELN's Alzheimer's Vaccine Program
Generating Renewed Interest

Conclusion: We hosted a conference call yesteday with one of our Alzheimer's clinical consultants. The focus of the call was new data for Wyeth and Elan's Alzheimer's vaccine program, which Wyeth management highlighted at their analyst meeting on Wednesday. We drew the following conclusions from our discussion: (1) the one-year follow-up analysis of Wyeth/Elan's terminated AN-1792 Phase II trial provides important clinical evidence of the correlation between beta-amyloid levels and cognitive function; (2) Wyeth/Elan's immunotherapy programs are the most promising disease modifying approaches, although a commercial product remains 4-5 years away; (3) agents which slow beta amyloid aggregation are potentially viable, but not likely as effective as a vaccine; (4) the beta and gamma secretase inhibitors in development continue to disappoint; (5) statins may gain broader use as prophylactic treatment for AD; and (6) use of Forest's Namenda is expanding from moderate-to-severe AD patients into the mild-to-moderate population, which may drive a second leg of growth.

_ WYE/ELN's AN-1792 Follow-Up Data Generating Renewed Buzz. Our clinical consultants recently have been more bullish on prospects for the Alzheimer's vaccine program, based on a new follow-up analysis of the terminated Phase II trial for the first generation vaccine candidate, AN-1792. These data, which will be presented in full next month, indicated that patients achieving a high antibody response to the A-beta peptide showed a lower rate of memory loss over the one year. Wyeth/Elan have an MAb in Phase I and plan to take a 2nd generation peptide to Phase I in early-2005

[New-born baby]

What's happening?

King,

I am posting here because you've been too quiet too long. What's the news on ELN? I look for your post here every day, but it has been nearly a month since you've said anything. Please inform us of the news.

Thank you and the best investing to you always,

[kingofthehill]

sorry guys for not posting sooner, i could not find this site to save my life... my thinkpad crashed with ALL my bookmarks...i was adding a s each time

mrmarketsishuge.com

and google comes up with nothing...anyway here we go ..

all is well ..infact VERY WELL.. the only worry right now is Priority review for ELN ( and thats a worry for options players only).. if we get it in the next 3 weeks ..a nice pop up ..otherwise guys will short it the stock will move up in late July otherwise .. also


JP MORGAN SAYS ...ANTEGREN IS THE NEXT BLOCKBUSTER DRUG! 6/21/04

ELAN WILL MAKE A BIG SPLASH AT THE ALZHEIMER'S CONFERENCE IN PHILLY JULY TH ...HUGE HUGE HUGE....


ANTEGREN WILL OUTSELL ALL MS DRUGS COMBINED .. THATS A BIG STATEMENT AND I WILL STAND BY IT ... OCT. 7TH THEY WILL ANNOUNCE THE DATA IN VIENNA AUSTIRA... HUGE NEWS... NBC NIGHTLY NEWS NEWS.. WE HAVE BEEN TOLD..

THE BEST SITE FOR ALL INFO ON ELAN IS

https://WWW.TIXX.COM/ELAN.HTM

https://WWW.ELAN.COM

LA TIMES STORY ON THE HUGE PLANT BEING BUILT FOR ANTEGREN!!!!

http://www.tixx.com/biotech_factory.htm

ASK ANY QUESTION I WILL CHECKIN 3 TIMES A DAY ..

[kingofthehill]

QUOTES FROM Annual meeting transcript.... LAST WEEK

"It will be published in October, but through the actions by the FDA, we clearly suggest this drug will be more than exceptional".

"
Concerning the Alzheimer programs, we always have to remember that that is the core of our scientific effort. That is the cure of Alzheimer's disease is the reason for being for us as a company. Antegren was actually a spin-off of the Alzheimer programs"

SEC..."They have just finalized all of their analysis and sometime over the next month we would hope to be in dialogue with them. Again, it's not our time table, it's theirs, and we are working with them as closely as we can to make sure we can get to the point we can actually have substantive discussion" But, as I said earlier we are very hopeful that a resolution will come in the relatively near future.

Doctor on Antegren..."About 40% of the people that I treat now have abandoned these drugs and are desperately waiting for Antegren"

"Our discussions with the FDA and Lars can articulate later, I think could be classified as quite unique. Because the FDA, their responsibility ultimately, is to bring safe and breakthrough products to the marketplace. Hence the filing of the data with filing of MS, and filing of MS with one year data, which had never been done before".

"That was a decision that was not an Elan or Biogen decision; it was an Elan, Biogen, and FDA decision"

https://WWW.TIXX.COM/ELAN.HTM

[jiesen]

google search

mrmarketsishuge.com

and google comes up with nothing...anyway here we go ..

maybe it was because you misspelled 'mrmarket'! (it's not 'mrmarkets')



good luck with ELN. looking good so far...

[kingofthehill]

from the AGM in Dublin last week

Kelly Martin is the CEO of Elan

Kelly Martins words below were the key words on antegren.

Our discussions with the FDA and Lars can articulate later, I think could be classified as quite unique. Because the FDA, their responsibility ultimately, is to bring safe and breakthrough products to the marketplace. Hence the filing of the data with filing of MS, and filing of MS with one year data, which had never been done before. That was a decision that was not an Elan or Biogen decision; it was an Elan, Biogen, and FDA decision.

https://www.tixx.com/elan.htm

[Michaelk005]

Hey King, whats your thoughts on the FDA's upcoming approval of this new ELN drug? I do not honestly see a reason why they wouldnt let it out on the market but I'm wondering your thoughts. If this announcement goes all well, we could easilly see a 3$ price move.

[Websman]

King, I'm sure you've already posted it, but when is the potential approval slated for?

I definitely want to get in before the big news.

[stocks54]

Any other stock like ELN

Greeting kingofthehill,

Eagerly waiting for ELN's Fast Track approval. Do you for see any other stock which might have potential like ELN (I remember you made great call for OSIP)

Regards,

[jiesen]

pre-approval company

LJPC is one to look into if you want a good pre-approval play.

[stocks54]

Thanks

Thanks jiesen,

I will check LJPC.

Regards,

[kingofthehill]

Priority review could come this week till July 25th

here is a great Forbes article from Friday

http://www.forbes.com/markets/2004/06/25/0625automarketscan07.html?partner=yahoo&referrer=

also ... hold on to your chair while you read this article about Elan's Alzhiemers program

Some observers presume the results are at least encouraging, because Elan has continued to pursue the protein theory in creating new experimental vaccines.

Selkoe said he doubts the study results will be a "slam dunk" proving his theory; but expects it will show a measure of improvement.
And that, he said, would be a big deal in terms of trying to find a vaccine or cure.
"Obviously, in the Alzheimer's field, we're grasping at straws." he said.

He said he also expects other reports scheduled to be given at the conference to bolster his amyloid protein theory.

Meanwhile, Elan and other companies are working on other vaccines. Elan started enrolling patients last fall for a new study involving an improved vaccine that should not have the brain swelling side effects. Selkoe performed research that helped in tackling that side effect problem.

The previous vaccine was a tiny dose of the actual protein, and the intent was for the patient's body to create immune system antibodies that would consume the protein everywhere it occurred. However, the immune system reaction was so strong in some patients that it caused the brain swelling.

The new vaccine contains a tiny does of the antibodies, pre-made in the laboratories. Vaccine that use antibodies tend to be safer, but also weaker Selkoe said. The Fedral Food and Drug Administration is still reviewing the new vaccine's safety. Selcoe said it will probably be about 18 months before there are any test results.

Elan and other companies are also working on drugs that would block the body's ability to create amyloid proteins in the first place.

All of this contributes to Selkoe's upbeat opinion of the state of Alzheimer's research. "My viwe of that is optimistic" he said. But, he added even in the best case scenarios, it's easily three to four years to anything real" in terms of vaccines.

Since Alzheimer's began receiving major scientific attention in the 1980s, many rumors have flown about ways to avoid it, ranging from eating fish to not using aluminum containing deodorants.

"I can't recommend a diet ..... that would protect anyone from Alzeheimer's" said Selkoe. " When you look at environmental causes, there's precious little scientific data."

He noted the disease occurs around the world in roughly equivalent rates. The Japanese, who eat far more fish than Americns do, have a similar Alzheimer's rate. And you can still use your deodorant; " Aluminum for sure is not likely to be important." Selkoe said.

One thing that is clear to researchers, Selkoe said, is a genetic component to the disease.
"I always tell lay audiences - Choose your parents carefully" Selkoe joked. More seriously, he noted that having a genetic predisposition for Alzheimers doesn't automatically mean someone will contract it.

END of Full Article

i will get the link posted to the full story..

[kingofthehill]

RING THE BELL BOYS WE HAVE A WINNER

FDA Designates Antegren Biologics License Application for Priority Review as a Treatment for Multiple Sclerosis
Monday June 28, 2:30 am ET
Application Under Accelerated Approval Guidelines


CAMBRIDGE, Mass. & SAN DIEGO & DUBLIN, Ireland--(BUSINESS WIRE)--June 28, 2004--Biogen Idec and Elan Corporation, plc announced today that the Biologics License Application (BLA) for ANTEGREN® (natalizumab) has been designated for Priority Review and Accelerated Approval by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS). The next step in the process is action by the FDA on formal acceptance of the application, which occurs within 60 days of submission.
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The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for natalizumab in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On May 25, 2004, the companies announced they had previously submitted the BLA for the approval of natalizumab for MS.

"We are pleased that the FDA has designated natalizumab for Priority Review," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to continuing to work with the FDA throughout the review process to provide this potential new therapeutic to patients with MS."

"The Priority Review designation underscores the significant unmet medical need in the area of MS," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We believe natalizumab will offer a new approach to treating MS and will bring hope to patients living with this disease."

The BLA for natalizumab is being evaluated by the FDA under Accelerated Approval guidelines. This review will be based on one-year data from two ongoing Phase III trials. The companies are committed to completing these two-year trials. In order to protect the integrity of the trials, the companies are not disclosing the one-year data at this time.

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and approximately one million people worldwide. It is a disease that affects more women than men, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About the MS Clinical Trials for ANTEGREN