MY PICK IS ELN

[Michaelk005]

I really apreciate all the new new info King, making following this stock an easy thing. My personall guess is that this stock will hit $26 before the announcement and 35 - 40 after its aproval. I'm going to buy another nice chunk when it goes to $22.80 or if it does, this is because if there is the poosibillity this doesnt get aproved a have a $2-3 dollar leeway.
Do you have a safety net in place incase of a non approval?

[kingofthehill]

Biogen Idec the world's 3rd largest Pharma, is Elan's partner. they are already building a plant in Denmark for production.

The FDA asked Elan & Biogen to fast track the drug..why ask the companies to come in early if your not going to approve..

also if Antegren gets delayed it will be a $10.00 drop in share price not 2-3 bucks


I am full steam ahead no puts or stop loss orders for me

puts would be a good idea


today news Elan is added to the FTSE 300

http://www.ftse.com/./tech_notices/2004/q3/09075_20040909_EUROPEAN_INDICES_REVIEW.jsp

[kingofthehill]

From the Sunday Tribune, Sept. 12, B8, Hermes commentary (no link):
ELAN REPLACES RYANAIR IN EUROTOP 300
FOLLOWING a quarterly review of its European, US and UK market indices, FTSE has dumped previous darling Ryanair from the Eurotop 300 Index and welcomed new love Elan into its arms.
The Eurotop 300, as the name suggests, tracks the performance of the continent's top 300 companies as classified by market capitalisation. Gaining entry represents quite a milestone for comeback kid Elan
Its shares are still high on the effects of a new drug application for Antegren, the potential blockbuster drug for treating MS. Elan shares are up over 230% this year and are currently trading at around €19.30, valuing the company at €7.4bn. Not bad for a business looking to make a €330m pre-tax loss this year and still under investigation by the US Securities and Exchanges Commission over alleged accounting irregularities.
Contrast Elan's fortunes of late with Ryanair, the company it passes out on its way into the Eurotop Index.
Ryanair stock is down 36% this year and remains sluggish, tranquillised by the twin darts of rising oil prices and heavy competition in the low fare airline sector. Investors can't overlook rising oil prices and are right to be concerned about competitive pressure on earnings, at least in the short term, a problem underlined by Ryanair's first ever profit warning to the market earlier this year.
Antegren promises much and if it gains approval, makes it to market and delivers the kind of sales many are predicting, it may yet make Elan shares look cheap, even at their current level.
Yet the market seems to find it easier to believe serial underachiever Elan can change its luck than to accept proven outperformer Ryanair will deliver on its promise to beat off the low fare upstarts. Go figure.
// This underlines that Elan will be bought by the European (or at least Irish) "growth" or "momentum" investors who used to favor companies like former darling Ryanair. I use Ryanair to get around cheaply, but the number of repeated low cost offers to fill seats suggest they are facing a difficult winter and Elan has to look better to this group of investors/portfolio managers

[kingofthehill]

NYSE:ELN
for the period from 09/10/2004 to 09/14/2004 gained 2 %
Now it would be useful to recall that our analysis of the trading flow detected the changes on the early stage of development and pointed to this possibility before the weight of evidence indicates:
09.07.04 Inflow Detected
Based on the results of 09.07.04 trading the price of the stock went up 1.17% and closed at $23.26. At the same time the number of shares traded in buyer-initiated trades exceeded the number of shares traded in seller-initiated trades by 93%. In this situation we assume that there was a significant Buyer interest in the security.

09.07.04 Unusually High Block to Retail Transaction Ratio Detected
Based on the results of 09.07.04 trading the price of the stock went up 1.17% and closed at $23.26. At the same time the number of shares traded in buyer-initiated trades exceeded the number of shares traded in seller-initiated trades by 93%, and 73% of the total volume were the large orders. In this situation we assume that there was a significant Buyer interest in the security and that the institutions were actively involved in the trading. Stocks with an unusually high block trade ratio are worth watching for future developments. Institutions are playing an important role in the stock market and a high block to retail transaction ratio is high for a reason.

[kingofthehill]

Study shows neurologists keen on Antegren

September 16, 2004 15:46
According to a study of neurologists by bankers Morgan Stanley, doctors are keen to adopt Elan's multiple sclerosis drug Antegren.

Morgan Stanley analysts said the survey of 105 high-prescribing US specialists in the disorder increased their confidence that Antegren would capture 30% of the market and reach global sales of $2 billion by 2008.

Antegren, which is expected to be launched next year, is a new class of drug for fighting MS and a key product for the fortunes of both Elan and its marketing partner Biogen. Antegren is administered as a monthly infusion, or drip, in the doctor's office. In Europe Antegren is not expected to be launched until 2006.


Morgan Stanley said the need for infusion equipment might limit use of the new product initially, since only 35% of neurologists surveyed had infusion capabilities, but the survey found 86% said this would only be a constraint for the first six months.

The bank estimated that the total US market for MS drugs would grow to $3.8 billion in 2010 from $1.8 billion last year with the EU market reaching $3 billion from $1.8 billion.

The new product will compete with existing treatments such as Biogen's established drug Avonex, Rebif from Serono, Betaferon from Schering and Teva Pharmaceutical Industries Ltd's Copaxone.

[kingofthehill]

Competitors: Serono closed InterPharm because of Biogen's Antegren

Antegren is due to receive marketing approval in November.

Globes' correspondent 21 Sep 04 19:27

The closure of InterPharm Laboratories has instigated an assault by its competitors, led by Biogen Idec's (Nasdaq:BIIB) Israeli representative, Medison Pharma. Medison Pharma CEO Meir Jacobson said, "I'm an interested party, but analysts in the US also agree that the expected entry of Biogen's Antegren, which is due to receive marketing approval in November, was one of the key reasons for the deteriorating position of our competitors that produce treatments for multiple sclerosis."
Jacobson says Antegen was also one of the reasons for the recent decline in the share price of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA), the manufacturer of Copaxone. But Teva has many other drugs, including a generic version of Serono's (NYSE:SRA; SWX:SEO) Rebif.

Jacobson said, "The decision by Serono's management to close its plant in Israel is completely unrelated to it being an obsolescent plant, or recent developments and changes in biotechnology production practices, as its announcement in Switzerland claims."

Serono informed InterPharm's employees it had sufficient capacity in the medium term without the establishment of a new plant in Ness Ziona, planned for the same site.

Jacobson said, "If they had to continue large-scale production, and not confine Rebif production to Switzerland only, they could have continued production at the existing plant in Israel, which meets all international standards."

However, Jacobson added, "Since Rebif accounts for over half of Serono's sales, and the blow Serono comes from the US too, it was forced to reduce operations. We believe that Serono decided to close its Israeli plant because of pending significant developments in the multiple sclerosis market with the entry of Antegren by the end of the year. All studies indicate that Antegren will be a breakthrough in the treatment of multiple sclerosis thanks to its effectiveness and the way it is used."

Published by Globes [online] - www.globes.co.il - on September 21, 2004

[kingofthehill]

http://cbs.marketwatch.com/news/stor...2D4849%2D88EF% 2DDAD8B2B6EE0A%7D&dist=rss&siteid=mktw

Hartford fund likes Elan, . . .
By Barbara Kollmeyer, CBS MarketWatch
Last Update: 12:01 AM ET Sept. 22, 2004

The manager of the Hartford International Capital Appreciation fund (HNCAX: news, chart, profile) invests without regard to country or benchmark allocations.

"We manage the fund globally and think about it on a global basis, with a huge emphasis on fundamental research," said Offit.

"We don't think the country matters," he added. "What's most critical to holdings is what's happening in the sector. What's not critical is the country they're located in. All the data, all the research, comes from the bottom-up stock workthat we do."

The fund manager looks to buy shares of industry leaders. "Our process starts with the universe of 1,000 names," he said. A team of analysts cover 95 percent of those companies, and visit more than 500 of them each year, he explained.

The fund's class-A shares rose 19 percent over the year through Sept. 20, beating the 13 percent gain for its international-fund rivals, according to investment research firm Lipper. Its three-year annualized 17 percent return tops its peers' 9 percent average gain.

Pharmaceutical giant Elan (ELN: news, chart, profile) is a favorite.

Offit lauded the Ireland-based firm's joint venture with U.S. drug group Biogen Idec (BIIB: news, chart, profile). Together, he said, the two are producing "the most exciting drug to come to market in several years." That drug is Antegren, which treats multiple sclerosis, and is expected to receive U.S. Food and Drug Administration approval by November, he added.

"Every indication has been that the data is very strong," on the drug, Offit said. Antegren acts to slow the progression of multiple sclerosis, but, more importantly, without the difficult cold and flu symptoms that are side effects of existing MS drugs. Even better, the drug is taken once a month, versus every day.

"We're glad Biogen is involved. It's a good company...they know the market well. It's a good partner for Elan." Offit said, adding that Elan has also filed for drugs to treat Crohn's disease and rheumatoid arthritis.

U.S.-traded shares of Elan rose 21 cents on Tuesday to $24.27.

[kingofthehill]

http://www.tixx.com/goodbodys-crohns.htm

new report

[tokyojoeskid]

king

I really like the outlook on eln but in this market skeptical of everything. I have gotten burned by some stocks in the past qvdx, hbio blah blah blah
So I buy 100 shares of eln you think it would be wise to also buy the jan05 puts at 20 for 2.10. I suppose that way im limited to a 5pt loss (including premium) if i bought the stock today and it dropped, do you think if the antegen results come in positive, the stock will boost past 25 and be worth it?

tjk

[Michaelk005]

YES without a doubt

[Websman]

Maybe I'll finally get into ELN tomorrow. It's looking good.

[tokyojoeskid]

m005

So what is a better deal the 22.50 for 3.10 or the 20 for 2.10. Seems to me that if i take the 22.50 I would loose less if the stock crashed, $100 less assuming(just buying one contract). But if the stock were to go way up, the put expires then i wouldnt gain as much, as if i bought the 20's for 2.10.

Does anyone have any insight when it comes to which one to purchase, or is it really just a gut thing on my behalf.

[kingofthehill]

this report is written about Elans partner Biogen

ANTEGREN –A POTENTIAL BLOCKBUSTER FOR MS SEPTEMBER 24, 2004 PRUDENTIAL RESEARCH REPORT (16 PAGES)

Antegren, Biogen’s potential blockbuster for multiple sclerosis (MS), is currently under review by the FDA, with a decision expected by Thanksgiving. Antegren was granted priority review and accelerated approval based on an interim look at one-year data from an ongoing 116- week study. To date, this one-year data has not been released publicly.

Once approved, Antegren will be the first in a new class of selective adhesion molecules (SAMs) with the potential to revolutionize MS therapy.

As we await the release of the one-year data and the FDA’s decision, we wanted to review what is known about Antegren to date and to review the possible positioning of the drug in its lead indications of MS and Crohn’s disease.

We expect Antegren to be used as monotherapy in MS and in combination with commonly prescribed interferon. This would represent the first combination approach to the treatment of MS.

Assuming the Phase III data is similar to the Phase II data (which was the premise for the accelerated approval), we expect Antegren to be as efficacious as the interferons, but with a superior side effect profile and added convenience.

ANTEGREN COULD BE APPROVED BY THANKSGIVING. On June 25, 2004, Biogen announced the FDA's early decision to give Antegren priority review. With a six-month review now official, we believe the PDUFA date falls around November 25, or six months after the May 25 filing. Priority review status is granted when a product is perceived to be a significant improvement over currently marketed drugs for that indication. Such improvements would include increased efficacy, reduced treatment-limiting adverse events, enhanced compliance, or safety and efficacy in a particular subpopulation.

--What conclusions can we draw about the profile of Antegren from this priority review designation?

We believe that its efficacy may be an improvement to current treatment options given that management indicated that it would only have filed early if the Phase III data were consistent with the Phase II data, and if there were meaningful synergies with Avonex, Biogen’s currently marketed treatment for MS.

Antegren is likely to reduce treatment-limiting adverse event(s) associated with current MS medications. Nine-month data from ENACT-2, which used the same 300 mg dose as the AFFIRM and SENTINEL trials, presented at Digestive Disease Week in May 2004 showed that Antegren was safe and well tolerated. Antegren may enhance patient compliance via less frequent dosing (i.e., once-monthly IV infusion for Antegren versus weekly injections for the interferons and daily injections for Copaxone), and a better side effect profile.

Antegren may be efficacious in subpopulations of patients who are intolerant of, or refractory to, interferon. Again, we need to see the Phase III data before we draw conclusions regarding subpopulations.

WE THINK AN ADVISORY COMMITTEE REVIEW IS UNLIKELY. Given the early nature of the submission, the FDA could opt to have an expert panel review the data and give their recommendation regarding approval. To date, though, the FDA has not scheduled such a meeting. Typically, the FDA notifies the sponsor 60 days prior to the scheduled meeting and with a late November PDUFA date, we are closing in on the 60-day period. We note, however, that this 60-day period, while typical, is not set in stone and at any time before the PDUFA date, the FDA could advise Biogen that a meeting is required.

WHEN WILL THE ONE-YEAR ANTEGREN DATA BE UNVEILED? Should Antegren be subject to a panel meeting, this would likely be the first public viewing of the one-year data. Should the FDA decide not to have a panel meeting and following approval around the estimated late November PDUFA date, the label would be the first glimpse of the data. We were hoping to see the data in October at the ECTRIMS meeting (a major MS meeting taking place in Vienna, Austria), but the FDA has not permitted Biogen to release the data at this meeting in order to maintain the integrity of the ongoing two-year trial. Bear in mind that compared to release of the data at ECTRIMS, the release of the data at a panel meeting would only constitute a short delay of 1-3 weeks (40-50 days if the data are released in the label). We view the data release as an important catalyst for the stock, so we will be paying close attention for any decisions regarding a panel meeting.

Manufacturing is on track. We believe that Biogen's manufacturing facilities are ready to ship sufficient quantities of drug should Antegren be approved in November. At launch, Antegren will be manufactured at the Research Triangle Park facility in North Carolina where current capacity is 90,000 liters, which the company indicates should supply 70,000 patients.

Biogen will require an FDA license for the plant prior to commercial production. Biogen is also ramping up for production in an IDEC facility in Oceanside, California, which has capacity of 90,000 liters. This facility should be on line by mid-2006. Management believes that process improvements to these plants could double capacity to 380,000 liters. In addition,

-- To the frustration of the investment community, the company has not yet released the one-year data from AFFIRM or SENTINEL, for what we think could be three reasons:

To maintain the integrity of the trials, which are still ongoing;

To gather an additional six weeks of data in order to make the data set more robust; or

For competitive purposes.

Although we have not seen the data, we do know that the company previously stated that it would not have filed early unless the data looked at least as good as the Phase II data.

To get an idea of what we may see in the Phase III data from AFFIRM or SENTINEL, we examined the Phase III results revealed in May 2004 from the ENACT-2 trial in Crohn’s disease for insight into Antegren’s long-term safety. ENACT-2 was a nine-month study using the same 300 mg dose as AFFIRM and SENTINEL. In that trial, Antegren was safe and undifferentiated from placebo in terms of adverse events. We were encouraged to see a clean safety profile for Antegren, which would likely be welcome by MS patients, who are burdened by drugs with significant adverse events, including infection and flu-like symptoms.

[kingofthehill]

this is very big news

Ireland's Elan submits bowel drug for EU approval
Wed Sep 29, 2004 07:33 AM ET
LONDON, Sept 29 (Reuters) - Ireland's Elan Corp (ELN.I: Quote, Profile, Research) submitted its flagship Antegren drug on Wednesday for approval by European regulators as a treatment for bowel disorder Crohn's disease, saying tests showed it worked over a 12-month period.
Antegren, which is being developed with U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) , has led a dramatic recovery in Elan's fortunes, after its stock plunged 90 percent in 2002 on concerns about liquidity and an accounting probe by U.S. market regulators.

Analysts think the medicine, which is being developed primarily as a treatment for multiple sclerosis but also for Crohn's disease and rheumatoid arthritis, could eventually generate annual sales of more than $1 billion.

Elan, which has also sold assets and slashed costs to recover from a brush with bankruptcy, said new data showed 54 percent of Crohn's patients recorded a continued response to Antegren after 12-months of a final Phase III clinical trial.

This compared to a response rate of 20 percent from patients on a placebo and a 61 percent response rate recorded by patients on Antegren after six months of the clinical trial.

Some 39 percent of patients on Antegren remained in remission after 12 months, versus 15 percent of those on a placebo and 44 percent after six months.

In addition, 49 percent of Antegren patients who had previously received steroid therapy were able to withdraw from steroids at the end of the 12-month period, compared with 20 percent of placebo-treated patients.

"This filing and the presentation of 12-month data from the ENACT-2 study represent important milestones in our development of natalizumab (Antegren) as a treatment for Crohn's disease, and we are committed to working closely with the European regulators to facilitate a thorough review of our submission and the supporting data," said Lars Ekman, executive vice president and president for research and development, in a statement.

At 1030 GMT, Elan shares were up 0.2 percent at 19.38 euros.

Crohn's disease is a chronic and progressive inflammatory disease of the gastrointestinal tract, which cases diarrhoea, abdominal cramps, often fever and at times rectal bleeding.

Elan and Biogen submitted Antegren for U.S. approval as a treatment for multiple sclerosis in May and announced in June they had received a priority review from the U.S. Food and Drug Administration to speed up the assessment process.

The two firms said in May they would submit Antegren for European approval in Crohn's disease in the fourth quarter.


© Reuters 2004. All Rights Reserved.

[kingofthehill]

Elan announces that it will take a $55m charge in its interim results which will be filed this week. The charge is a reserve ahead of the resolution of SEC’s investigation and the settlement of its outstanding shareholder litigation. Today’s announcement should be seen in the context that a deal between Elan and the SEC and Elan and its class action suits has been completed but the tying up of certain legal loose ends means Elan were not able to keep to their end of September deadline. By announcing interim results this week and highlighting the size of the charge Elan is clearly telegraphing to the market that the SEC resolution and shareholder litigation are benign events and full disclosure about their resolution is imminent. A reserve of $55m coupled with their insurance coverage of $50M implies a total payout of $105m for SEC fine and shareholder suits. Such a total payout, if confirmed, would be at the low end of expectations and hugely positive for the company. Such a benign outcome could also be catalyst for a stock re-rating, as many US mutual funds are precluded from owning stocks that are under federal investigation