MY PICK IS ELN

[kingofthehill]

Irish Times Today

to read the latest reports on Elan go to http://www.tixx.com/elan.htm

Elan's SEC and lawsuit settlements boost shares
Una McCaffrey
Shares in Elan strengthened yesterday as the market welcomed news that the company could finally move on from a major US regulatory investigation.
It emerged on Monday night that the US Securities and Exchange Commission (SEC) had levied a $15 million (€11.8 million) fine on Elan after completing a formal probe into the firm's accounts.
Crucially, the fine did not involve any admission of liability on Elan's behalf. This supported the firm in its battle against a group of shareholders who were pursuing it for compensation in relation to share trades they had completed in 2000-2002.
Elan has agreed to settle with these shareholders for $75 million, again without admitting any wrongdoing. The firm's insurance will cover $35 million of this, thus leaving Elan's overall financial liability on the matter at $55 million. Elan reserved exactly this sum to cover the issue in its most recent accounts.
The resolution of the two issues is seen as a positive for Elan's share price, which yesterday gained almost 4 per cent in Dublin before attracting some afternoon profit taking. Shares closed eight cents stronger at €19.75. In New York, where the stock is mostly traded, shares gained 1.5 per cent to finish at $25.26.
Analysts predict further momentum behind the share price over coming weeks, as investment funds that were previously precluded from investing in Elan because of its regulatory problems look to take a position in the stock. However, hedge funds that were taking a bet on the outcome of the SEC investigation are likely to lose some interest in Elan, thus limiting its share price volatility.
Mr Richard Parkes, a pharmaceutical analyst with ING Barings in London, acknowledged yesterday that the settlement removed a degree of uncertainty from Elan's prospects. He believes, however, that further progress on the firm's flagship Multiple Sclerosis drug, Antegren, will be required to promote a dramatic shift in its valuation.
Antegren is being considered by the US Food and Drug Administration, which is due to make a decision on approving the drug by November 25th.
"The shares are likely to perform strongly running up to that," said Mr Parkes.
Mr Ian Hunter of Goodbody Stockbroker has a 12-month price target of $31.20 per share on Elan but he said that this would be conservative if news on Antegren was particularly positive.
Elan is likely to offer an update on Antegren when it reports third-quarter results tomorrow. The firm's partner on Antegren, Biogen, will report results tonight."
// nice comments, including the loss of volatility due to the hedge funds not having a reason to mess around, as well as Richard Parkes' comments on the run-up to Antegren as well as Ian Hunter's comment that $31.20 could be conservative

[kingofthehill]

DOW JONES NEWSWIRES
October 29, 2004 2:33 p.m.

The following is a press release from Moody's Investors Service:
New York, October 29, 2004 -- Moody's Investors Service placed the ratings of Elan Corporation plc (Caa2 senior implied) under review for possible upgrade.

This rating action follows the company's announcement that it plans to issue $850 million in new senior notes, and that it will use proceeds to purchase up to $351 million of its $390 million EPIL III notes maturing in March 2005. Moody's rating outlook has been positive since April 16, 2004. Moody's believes that the issuance of new senior notes -- if successfully consummated -- should alleviate earlier concerns about Elan's near-term liquidity, stemming from insufficient internal sources of cash to repay the EPIL III maturity and significant cash flow burn.

The rating review will focus on: (1) Elan's capital structure and liquidity profile assuming successful completion of the bond offering and EPIL III tender offer; (2) structural considerations of the new notes relative to Elan's existing debt; (3) anticipated financial performance over the near and intermediate term, which may still include significant cash flow burn; and (4) longer term opportunities provided by Antegren, which is currently being reviewed by the FDA.

Moody's anticipates concluding the rating review in the very near term, as well as assigning a prospective rating to the new senior notes.

Ratings placed under review for possible upgrade:

Elan Corporation plc

Caa2 senior implied

Caa2 issuer rating

Athena Neurosciences Finance, LLC

Caa2 senior notes of $650 million due 2008 (guaranteed by Elan Corporation on a senior basis)

Elan Pharmaceutical Investments III Ltd. (EPIL III)

Caa2 senior notes of $390 million due 2005 (guaranteed on a subordinated basis by Elan Corporation plc)

Moody's does not rate Elan's $460 million convertible notes due 2008.

Elan is a specialty pharmaceutical and drug-delivery company headquartered in Dublin, Ireland, with current areas of pharmaceutical focus in neurology, pain management and autoimmune diseases.

[kingofthehill]

Elan announced last night an $850m debt re-financing. The $850 million is an aggregate principal amount of senior fixed rate notes due 2011 and senior floating rate notes due 2011. There is no convertible component and therefore no equity dilution. The funds raised will be used to pay off EPIL III debt (through a cash tender offer) and for general corporate uses. As of yesterdays results Elan had $780 in cash and $275m in investments for disposals, with $390m in debt due in 2005. However with a return to profitability only expected in 2006, a debt re-financing was always on the cards. Yesterdays results also highlighted that the impending approval and launch of Antegren for MS, will substantially increase Elan cost base. If Antegren is to be successful Elan needs to have the finances to execute the marketing of a Drug which has the potential to be the gold standard in a MS market approaching $4.5bn in Annual sales, especially as the global penetration of current treatments among MS sufferers is 28%. This debt re-financing is a positive move and the early re-payment of the contentious EPIL III special purpose vehicle may be one of the terms of Elan’s provisional SEC settlement. "

[kingofthehill]

there are a lot of rumours about a meeting in London this week ..

this article is in one of the Dublin Newspapers Sunday

"Elan's Antegren expected to get UK test boost"
John Mulligan
It is understood that investigators monitoring studies into the multiple sclerosis treatment Antegren, developed by Irish drug company Elan and being tested with its US partner Biogen Idec, are considering meeting in London this week. This follows study results that have shown the treatment to be more effective than expected.
It is believed that preliminary findings have shown that the drug may be helping to reverse the effects of the ailment in patients involved in trials.
Elan is expected to release data from the final phase of Antegren trials in the last week in November. However, it is believed that at least one trial involving approximately 20 patients, where 13 were receiving the new drug and seven were taking placebos, all 13 of the patients showed marked improvement in symptoms, while four of them say an improvement in their so-called Expanded Disability Status Score (EDSS).
Neurologists use this scale to rate the progress of the disorder in patients. Zero indicates normal neurological function while 10 represents death. Patients with a score of 7 for instance, are confined to a wheelchair.
Elan and Biogen must show that the effect of Antegren on disability progression can be sustained for three months.
The US Food and Drug Administration gave Antegren priority review last June. The agency could grant approval for the drug by the end of November, allowing Elan and Biogen to begin large-scale production early next year.
Last week the Sunday Tribune reported that Elan was to agree to settle class action suits against the company for $75m. The company confirmed the settlement last Monday.
Additionally, it said that it had reached a provisional settlement with the Securities and Exchange Commission (SEC) which will see the company pay a fine of $15m to bring to a close investigations into the company.
The SEC meets for a closed session this Wednesday in Washington and a final rubber-stamping of the agreement is expected to take place, which will leave many new fund managers free to begin buying Elan’s stock.
At the moment about 220 funds have invested in Elan – way off the high of more than 400 before investigations began into the firm. [end]

[kingofthehill]

aBiogen Idec and Elan Announce Webcast to Discuss Antegren Accounting


CAMBRIDGE, Mass. & SAN DIEGO, Calif. & DUBLIN--(BUSINESS WIRE)--Nov 1, 2004 - Biogen Idec Inc. (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) will host a conference call for the investment community at 8.00am ET / 1:00pm GMT on Wednesday, November 3, 2004. Peter Kellogg, Biogen Idec's CFO, and Shane Cooke, Elan's CFO, will review the accounting methodology for ANTEGREN(R) (natalizumab). The live webcast is accessible through Biogen Idec's website, www.biogenidec.com and Elan's website, www.elan.com.

[kingofthehill]

Fidelity Investments announced then now own 9.7% of all ELN stock..thats great news >>Wellington Funds announced they added 5 million shares last week for a total of 27 millions shares of ELN ..ans S&P upgraeded Elans debt today..all good news..press conference Wed. Am about Antegren accounting with Biogen ..

[tokyojoeskid]

king

King,
Lets just come up with a hypothetical.

Eln's Antegen is approved. Are you in this one for the couple day pop or for the long run following the approval?
TJK

[kingofthehill]

truely , this is one of those few stocks i will hold for a year, i have sweated all the rumors..it this point im more worried about a buyout more than anything else.

Elan has the chance to book all the US sales Antegren , and split profits with Biogen ..pricing info might be out Wed. am this could really show the sales numbers for the drug. i will post as much inof as i get.. this stock is hardly followed by retail USA investors..its a keeper for a year at least ..now if the stock was to pull an OSIP and double in one day i would sell.. i cant turn down that kind of offer or profit

[kingofthehill]

11/2/04 Bloomberg TV on Antegren ..." THE SAME CAN BE SAID FOR ELAN. I THINK IT DEPENDS IN THE VERY
NEAR TERM OR IF YOU'RE TALKING 12 TO 18 MONTHS. I THINK ELAN HAS 30%, 35% UPSIDE HERE IN THE NEXT SIX TO
12 MONTHS BASED ON ANTEGREN ALONE. IF YOU LOOK OVER THE NEXT TWO TO THREE YEARS, I THINK ELAN STOCK
CAN DOUBLE, AGAIN WITH THE VIEW ANTEGREN IS A SUCCESSFUL AS I BELIEVE IT CAN BE.

[kingofthehill]

Kris Jenner of the T. Rowe Price Health Science Fund discussing his top picks on CNBC at 9:16 am ET:
.."Elan is another top pick in the fund and probably one of the most exciting new medicines to track in the
next couple years, Antegren, which we think could transform the treatment of multiple sclerosis."
--------------------------------------------------------------------------------

11/3/04 Richard P. Collier to Join Elan as Executive Vice President and General Counsel


--------------------------------------------------------------------------------

11/2/04 Bloomberg TV on Antegren ..." THE SAME CAN BE SAID FOR ELAN. I THINK IT DEPENDS IN THE VERY
NEAR TERM OR IF YOU'RE TALKING 12 TO 18 MONTHS. I THINK ELAN HAS 30%, 35% UPSIDE HERE IN THE NEXT SIX TO
12 MONTHS BASED ON ANTEGREN ALONE. IF YOU LOOK OVER THE NEXT TWO TO THREE YEARS, I THINK ELAN STOCK
CAN DOUBLE, AGAIN WITH THE VIEW ANTEGREN IS A SUCCESSFUL AS I BELIEVE IT CAN BE.

[kingofthehill]

GOLDMAN SACKS COMMENTS ON ELAN

As part of its pre-launch plan, BIIB may be presenting Phase III data on Antegren to
clinical investigators this weekend. Data from both the monotherapy and combination
therapy at 1 year, and potentially monotherapy at 2 years, might be presented. Release of
the data should help educate physicians and payors ahead of the potential FDA approval
by 11/25/04. Management has indicated previously that Phase III data of the monotherapy
study are similar to those from the Phase II trial. However, if the combination data and 2
-yr data are positive, BIIB shares should react favorably. The current share price implies a
75% probability of a positive FDA outcome by 11/25/04. We continue to believe that a
positive outcome is more likely. The shares should trade between mid 60's and mid 40's
depending on the FDA action. At $65, the PE is 38X our 2005 EPS and 31X consensus
2006 EPS or PEG of 1.9 and 1.5, respectively. We maintain our In- Line rating and
Neutral coverage view.
I, Maykin Ho, Ph.D., hereby certify

[kingofthehill]

this is it congrats,...were are really moving...Elan (ELN) jumped 9.8 percent after it and Biogen Idec (BIIB) said one-year data from its Phase III trial of Antegren met its primary endpoint of clinical relapse rate reduction for multiple sclerosis, and said its secondary endpoints also were met. But it also said that adverse events were 2 percent more common than in placebo-treated patients.

It said two-year results will be available in the first half of 2005. The drug was previously designed by the Food and Drug Administration for priority review.

[Michaelk005]

Thoughts on this letter?

+DJ Serono Keeps Rebif Target After Antegren Study>SRA

11/08/2004
Dow Jones News Services
(Copyright © 2004 Dow Jones & Company, Inc.)



(MORE) Dow Jones Newswires

11-08-04 0530ET

*DJ Serono: Rebif To Be Leading MS Drug In US, World By 2006



(MORE) Dow Jones Newswires

11-08-04 0531ET

=DJ INTERVIEW: Serono Not Worried About New Antegren Data


By Anita Greil

of Dow Jones Newswires

ZURICH (Dow Jones)--Swiss biotechnology company Serono SA (SRA) stands by its goal of rendering Rebif the most widely-sold multiple sclerosis treatment in the U.S., Andrew Galazaka, the company's senior Vice-President of Scientific Affairs, said in an interview Monday.

His comments followed the release of interim data on a study of Antegren, a rival MS treatment, developed by Biogen Idec (BIIB) and Elan PLC (ELN).

One-year phase III data of Antegren showed a 66% reduction in relapse rate compared with placebo. This compares favorably to Rebif, which showed a 40% reduction at one year in an earlier phase III, analysts said.

However, Galazka said it doesn't make sense to compare data from one placebo-controlled trial to another, especially if there are several years in between the two trials. Instead, he pointed to what he termed "serious" safety concerns associated with Antegren.

"The safety data from the Antegren study is limited, and only short term," he said. Serono, by contrast, has eight years of safety data for Rebif.

"We are reassured by the quality of this data (on Antegren) that Rebif if well on track to become the market leader in the U.S. by 2006, and therefore also worldwide," he said.

Serono is selling Rebif in the U.S. with the help and marketing muscle of Pfizer Inc. (PFE), the world's largest pharmaceutical company.

[kingofthehill]

Hopeful MS Drug Shows Progress

By DAVID ARMSTRONG
Staff Reporter of THE WALL STREET JOURNAL
November 9, 2004

An experimental multiple sclerosis drug, Antegren, prevents more relapses than drugs already on the market, according to some partial clinical-trial data released by Biogen Idec Inc. of the U.S. and Elan Corp. of Ireland.

Antegren is one of the most anticipated new drugs of the year. The U.S. Food and Drug Administration is widely expected to approve the drug this month after granting Antegren an expedited, priority review earlier this year.

The companies said Antegren -- whose chemical name is natalizumab -- reduced the rate of relapses 66% compared with a placebo's rate of reduction during the first year of treatment. A relapse is considered a temporary worsening of symptoms, such as difficulty walking, blurriness, tingling and numbness. Multiple sclerosis is a chronic disease of the central nervous system that affects about 400,000 people in the U.S.

The companies said the data, covering 942 patients, also show that four MS drugs on the market reduced the relapse rate 29% to 32% compared with a placebo after two years. Biogen and Elan said they didn't expect the relapse rate to change much at the two-year point. The two-year results will be released next year.

A number of analysts expect Antegren to be a blockbuster drug, with annual sales of more than $2 billion. The drug works by binding to cells that are believed to damage brain tissue and cause inflammation, thereby preventing the cells from crossing from the blood stream and into the brain.

The release of the data surprised investors, who had been told the companies wouldn't release clinic trial results until the FDA approved the drug. The companies said they decided to put out partial data now -- minus the actual rates of symptom reduction for each drug in the trials -- because trial investigators were briefed on the numbers at a meeting over the weekend.

Stephen Reingold, the vice president for research at the National Multiple Sclerosis Society, said the released results were significant, but not definitive. He said the placebo control groups in every clinical trial are unique, making comparisons difficult. The only way to know if Antegren is better than existing therapies is to conduct clinical trials comparing the drug directly to drugs on the market, he said.

The chief executive of Serono SA, the maker of rival MS drug Rebif, criticized Biogen for releasing only selected data. Ernesto Bertarelli said the failure to disclose full clinical trial results suggests some of the data is "not as pleasing as they like."

At 4 p.m. in New York Stock Exchange composite trading, Elan was up 4%, or $1.12, to $29 a share, while Biogen shares were down 46 cents to $60.40 on the Nasdaq Stock Market.

Investors and patients also are expecting results from a second trial involving Antegren that is being scrutinized by the FDA. That trial is investigating whether or not Antegren works better in combination with Avonex, an existing MS drug from Biogen. Those results, expected to be released this month, are critical to determining just how successful Antegren will be for Biogen.

Doctors, meanwhile, are eager to review data studying the effect Antegren has on slowing the progression of the disease.

Write to David Armstrong at [email protected]

[kingofthehill]

Elan (ELN US)
Previous close: 2897c
Bond offering increased to $1.15bn
[email protected]
• From what we understand to be very strong demand (estimated close to four times over-subscribed), Elan last night
increased and priced its debt offering.
• The size of the overall offering was increased from $850m to $1.15bn. This primarily comprises $850m fixed rate notes
2011 which were priced at par to yield 7.75%. These were trading at a yield of 7.29% in the aftermarket.
• The remaining $300m debt is a seven-year floating rate note, priced at three-month LIBOR plus 4% (except for the first
interest payment which is six-month LIBOR plus 4%).
• All necessary consents were received from the EPIL holders and only $39m of that debt will remain to be paid in March
2005.
• The new debt offering in itself, more so given its increased size, sends a signal that Elan is looking outwards as regards
investment opportunities. In-licensing and acquisitions are likely to be on the agenda though we do not believe any significant deals are imminent. Even with the increased interest costs, the company remains on track to return to profitability sometime during 2006