MY PICK IS ELN

[kingofthehill]

Morgan Stanley on Elan today -The company update is 7 pages, but only one page of text, the rest is disclaimers as usual.
Headline is "Litigation Resolution Getting Closer"
Text "This morning Elan announced that it will take a charge of $55 million on its income statement when filing its six months results prepared under Irish GAAP for the Dublin and London stock exchanges. This reserve is net of $50 million of insurance and is the company´s estimate of the liabilities to resolve the SEC as well as ongoing shareholder class action lawsuits.
This is very good news, in our view. With respect to timing, management had indicated that it believed it should be done with the SEC process around the end of September, so the timing is in line with expectations. The imminent resolution of the class action lawsuit is actually faster than our expectations. We thought that process would take at least until end of the year. Importantly, the payment amount is about what we had expected and it is not too onerous, in our view. We look for the formal resolution of these lawsuits this month and then all eyes will turn on the all important expected approval of Antegren by late November. "

[Websman]

Hey King, are you familiar with NRPH?

They have a new drug for treating Coke addicts that has been fast tracked and seem to have a few other things up their sleeve. It's ran up about $3 in the past two weeks.

[kingofthehill]

NRPH ..no idea ..Biogen/Elan drug may squeeze rivals
By Laura Gilcrest, CBS MarketWatch
Last Update: 3:27 PM ET Oct. 11, 2004

WASHINGTON (CBS.MW) -- Biogen Idec's pipeline drug Antegren - a first-of-a-kind therapy to treat multiple sclerosis - is expected to send the sales of competitors' drugs into freefall once the new drug hits the market, analysts say.

Although Biogen (BIIB: news, chart, profile) is still wrapping up clinical testing of its new multiple sclerosis therapy Antegren, Wall Street analysts are already calling the drug a force to be reckoned with in the multiple sclerosis market.

Antegren will dominate that market once approved, said market analyst Jason Kantor, with W.R. Hambrecht & Co.

"Sales of the other companies' drugs will be reduced proportionately," Kantor said.

The rosy predictions for the drug started with Lehman Bros. upgrade of Biogen shares Monday from "overweight" to "equal weight." See full story.

Buzz over the new drug pushed Biogen up 1.6 percent to $59.88 in afternoon trading.

With its unique therapy, Biogen likely will recapture multiple sclerosis patients who have gone off other therapies because particular drug didn't work or because it caused too many side effects, Kantor said.

Rival drugs including Biogen's own Avonex, Serono's (SRA: news, chart, profile) Rebif and Chiron's (CHIR: news, chart, profile) Betaseron are all interferon beta-based drugs. Avonex sales account for 40 percent of the market with Serono and Chiron close behind, he noted.

Seronon stock slid 1.6 percent to $15.13 in Monday trading, while Chiron - already saddled with troubles on the flu vaccine - continued to sputter, dropping 3.9 percent to $34.23.

In addition, Teva (TEVA: news, chart, profile) makes Copaxone, which works by a different mechanism of action than the interferon beta drugs and is approved for primary multiple sclerosis rather than the relapsed form of the disease, Kantor said.

Teva shares rose 1.5 percent to $25.30 in afternoon trading.

But Antegren is a so-called "antibody anti-adhesion" drug and takes multiple sclerosis treatment to the next level, he said.

Data from Biogen's Phase 3 clinical study suggest the drug is twice as effective as current multiple sclerosis therapies, but with fewer side effects, he noted.

The data show patients taking Antegren had one half the relapse rates as those on rival therapies, Kantor said. Plus, patients in the clinical studies generally didn't experience the flu-like symptoms common with interferon beta therapies, Kantor added.

Geoff Porges with Bernstein & Co. agreed that Biogen's pipeline drug would secure the company's place as the top player in the multiple sclerosis market.

"There is a lot of incremental share of the market still to be captured," Porges said.

In any case, Porges cautioned that the value of Biogen's shares attributed to Antegren's debut are to some extent already factored into the stock.

"Antegren has been talked about for the better part of a year." he noted.

The real question, Porges added, is how much revenue Antegren will generate once on the market, since Biogen will be splitting profits with marketing partner Elan, based in Ireland.

Nonetheless, Antegren revenue likely will be solid, since it will be the highest priced drug in its class, Porges predicted.

[kingofthehill]

(Irish) Sunday Tribune, 17 October 2004, main top lead of Business section:
Biogen and Elan ponder e8.5 bn merger
John Mulligan
BIOGEN IDEC and Elan, joint venture partners on the development of a major new multiple sclerosis drug, Antegren, are believed to be in “friendly" discussions about “future arrangements", according to well-placed US sources. It is believed that a deal could be struck within nine months and possibly before that.
The US firm is believed to be considering an offer for the Irish drugs company in an all-share transaction worth well in excess of €8.5bn.
Elan has declined to comment on rumours that it has entered into negotiations.
The two companies are joint partners in the development of Antegren, which could prove to be one of the biggest-selling global treatments for multiple sclerosis if approved by the US Food & Drug Administration.
Approval for the drug has been fast-tracked by the regulatory agency, suggesting that it sees the drug as potentially providing major benefits in the treatment of MS, the most common disabling neurological condition affecting young adults. Sales of the drug could be worth billions of euro in coming years.
The drug also has potential uses in patients with Crohns disease and rheumatoid arthritis.
Biogen, with a market capitalisation of €15.3bn, is precluded from making unsolicited bid for Elan under the terms of the joint venture project. In July, however, chief executive James Mullen, said that this "doesn't prevent us from having general business talks about whether something like that makes sense”.
Biogen Idec did not return calls seeking comment on the speculation. However, it is understood that contact has increased substantially in recent weeks.
Issues of timing may cast some doubt on whether Biogen Idec will indeed take a tilt at Elan. It could have acquired the company or merged with it under far cheaper terms months ago, when Elan’s stock price was worth a fraction of its current price.
It is possible that Biogen-Idec may have been waiting until Elan sorted out a number of housekeeping issues, including playing down its vast debt pile – which it has done with a number of drug and subsidiary stake sales – and resolving discussions with the US Securities and Exchange Commission over its accounting practices, for which it made a provision of $55m.
Last week, Elan sold its 3.8% stake in Warner Chilcott (formerly Galen) for 83m, which will help it to meet near-term debt commitments.
Elan chief executive Kelly Martin, has previously said he was happy with the status of the joint venture partnership, and that Elan was not seeking to cement the relationship further.
Elan stock was hit in the last 10 days following comments by Biogen-Idec’s vice president of medical research, Al Sandrock, who said European Union regulators may seek comparative data for Antegren versus another available treatment.
Further data for Antegren is expected next month from Elan and Biogen. [end]

// note to casual readers of this board: the Al Sandrock comments were taken out of context. There will be no head-to-head comparison before Antegren approval.
/// This story could be coming from the Biogen-Idec side, trying to bear-hug Elan. It does mean that Elan will be in play after the SEC and Antegren approval.

[kingofthehill]

Make or break for Elan's 'silver bullet'
Sunday October 17th
By Eamon Quinn
The countdown has begun. Within weeks investors in Elan will know whether they have backed the single best high-risk bet on the Irish market, or whether - for the second time in three years - they hold the stock market equivalent of a beaten docket.

The US watchdog, the Securities and Exchange Commission (SEC), is expected within days to deliver its verdict on Elan's former offshore and off-balance-sheet accounting practices.

Then, in a much more significant development, the US Food and Drug Administration will deliver a decision by November 26 on its fast-tracked six-month study into Antegren, a potential wonder drug for the treatment of Multiple Sclerosis (MS), which Elan jointly owns with US partner Biogen Idec.

Surprisingly, the SEC's ruling - after a two-year wait and after much concern that Elan would collapse under its own $1 billion (€800 million) of debt - is unlikely to unsettle the share price. Investors are clearly focused on a bigger prize than a favourable ruling from the SEC.

Elan shares barely budged last week when it sold off its stake in fellow Irish drug firm Warner Chilcott. According to analysts, an SEC ruling that said Elan would have to pay a fine of less than $50 million (€40 million) would be viewed as just a mild censure.

But it is the FDA decision on Antegren that will decide the fate of Elan shares.

Analysts at Davy and Goodbody Stockbrokers predict that the current share price of $21 in New York (€17 in Dublin trading) could soar to around $30 following a favourable FDA review.

"There's a concentration of events coming together in a matter of weeks with the SEC and the FDA,'' said Ian Hunter at Goodbody. "But Antegren is the key."

The Sunday Business Post first highlighted the potential of Antegren in an interview a year ago with Lars Ekman, Elan's head of research and development.

As noted at the time, Ekman abandoned the measured comments of his profession and talked enthusiastically about Antegren's potential for treating MS sufferers. He also talked about the outlook for the drug to be used also for Crohn's, a disease of the autoimmune system that leads to severe inflammation of the intestines.

"Antegren provides the most valuable, exciting development I have personally seen in my career," he told this newspaper. "It is the reason I joined Elan two and a half years ago."

In fast-tracking the trial for the drug, the FDA obviously also thought the same. It was an unprecedented move by the regulator. Never before in the history of MS treatments had the FDA ruled to cut the normal two-year period of testing on humans to only six months.

When Ekman was speaking 12 months ago, Elan shares were trading around a quarter of their current value.

what could happen to Elan shares if the FDA approves the drug next month?

Or has the share price already reflected the good news for Antegren?

The best scenario for Elan shareholders would be for the FDA to give full approval. The market would then pore over the test data to determine what share Antegren could capture of the €3.2 billion MS market, currently fought over by three drugs.

The more successful it is found to be against the rival treatments, the greater the potential uplift for Elan. "I would like to think it would make $28 on the back of news flow like that," said Jack Gorman, analyst at Davy Stockbrokers.

The rival MS drugs include Copaxone from Israeli company Teva and Rebif, produced by Serono of Switzerland.

But the biggest share of the MS drug market is controlled by Biogen, the firm with which Elan has partnered to develop Antegren.

Biogen owns outright the current best-selling MS drug, Avonex, and will have 50 per cent of the potential number one drug if the FDA data showed that Antegren were the superior drug.

The huge upside for Elan shareholders would be the potential for Antegren to be manufactured and brought to market by Biogen by mid-2005. A Biogen plant in the US would make the drug and Biogen would sell it through its existing MS sales force.

Elan would also sell Antegren through its smaller sales channel directly to US hospitals.

Under the brightest scenario, which includes full FDA approval and proof that Antegren was effective in treating MS sufferers who currently do not respond to Avonex, the Elan share price will soar, Goodbody's Hunter predicted. "$31 will be reached very quickly," he said.

The outlook also looks bright for Biogen shareholders, whose shares have already risen 55 per cent this year.

Would investors, if convinced by the Antegren story, be better advised to buy Biogen rather than Elan?

Davy's Gorman estimates that Avonex currently has 35 per cent of the of the market.

"It's a fair way of looking at things," said Gorman. "But say that Antegren is streets ahead of Avonex - Biogen could have problems in that Antegren starts cannibalising Avonex revenues, and the earnings could be at risk in a quarter or two."

Analysts said that with a less favourable outcome, the FDA could announce that the drug requires further tests. Investors will have to weigh that risk.

A successful outcome for Antegren in November would open up Antegren to be prescribed for Crohn's Disease, even though the drug has not been filed in the US as a treatment for the disease.
Nonetheless, physicians would be aware of the impending filing, and would probably substitute existing treatments for Antegren.

A successful FDA approval would make it more likely, not less, that Elan would issue a long-mooted bond issue by the end of the year, according to analysts.
The company has around $1 billion (€800 million) in debt, including the repayments due on the $390 million (€312 million) EPIL III vehicles (Elan Pharmaceutical Investments). A bond issue would help Elan to restructure its balance sheet.

"It's shaping up to be quite an exciting couple of months for Elan shareholders," said Goodbody's Jack Gorman.


The end of the article but the real beginning for the restructured Elan!

[kingofthehill]

Reuters
Biogen Mulling Bid for Ireland's Elan
Sunday October 17, 3:03 pm ET


DUBLIN, Ireland (Reuters) - U.S. drug company Biogen Idec is considering an all-share bid of more than 8.5 billion euros ($10.6 billion) for Irish peer Elan, a newspaper reported on Sunday.
Biogen and Elan, who are seeking regulatory approval for their jointly-developed Antegren multiple sclerosis treatment, are in friendly talks about "future arrangements," Ireland's Sunday Tribune quoted well-placed U.S. sources as saying.

ADVERTISEMENT


A deal could be struck within nine months, the paper said, adding that Biogen was mulling an all-share offer valuing Elan, which has a market value of 6.64 billion euros, at well in excess of 8.5 billion euros -- a premium of more than 28 percent.

The Sunday Tribune said it was understood that contact between the two companies had increased substantially in recent weeks as Elan gets its house back in order after a 2002 brush with bankruptcy amid worries over its accounts.

Elan, which is less than half the size of Biogen in terms of both revenue and market value, could not immediately be reached for comment on the report.

($1=.8011 Euro)

[kingofthehill]

Associated Press
Shares in Elan Surge on Takeover Reports
10.18.2004, 09:02 AM

Shares in once-troubled Irish drug maker Elan Corp. surged Monday after weekend reports that its main U.S. research partner, Biogen Idec Inc., could mount a friendly takeover bid.

Elan stock jumped 6.8 percent to euro18.15 (US$22.65) on the Irish Stock Exchange after Dublin newspapers reported Sunday that Biogen was considering an all-shares offer for Elan valued at more than euro8.5 billion (US$10.6 billion).

Elan spokespeople rejected the reports as baseless. Biogen Idec, which is based in Cambridge, Massachusetts, couldn't immediately be reached for comment.

Together, Elan and Biogen Idec are developing Antegren, a drug they hope can eventually be used to combat multiple sclerosis. The U.S. Food and Drug Administration is scheduled to announce Nov. 26 whether the drug can be sold on the American market.

Elan was once Ireland's highest-flying company and a darling of international investors, who were attracted by its focus on finding treatments or cures for diseases of the brain and nervous system, particularly Alzheimer's. Elan stock topped US$65 in mid-2001.

But a wave of bad news in 2002 sent it tumbling to below US$5. First, Elan's long-touted cure for Alzheimer's was dropped after trials found it caused potentially fatal brain inflammation. Then, Elan admitted hiding loss-making activities in the accounts of partnerships. Within weeks, Elan's financial reporting went from heavy paper profits to its first profits warning and signs it might not be able to service debts topping US$2 billion.

Over the past year a new management team has aggressively sold off assets and licenses, ended peripheral joint ventures and focused on core products. Analysts say the most important in the pipeline is Antegren, which is designed to help many of the approximately 1 million people worldwide suffering from multiple sclerosis.

Multiple sclerosis is a chronic disease of the central nervous system that can cause vision problems, loss of balance, numbness, difficulty walking and paralysis.

Antegren - which also is known by the generic name natalizumab - has been designed principally to slow the progression of disabilities related to multiple sclerosis, but Elan and Biogen Idec think it also can help sufferers of the gastrointestinal ailment Crohn's disease and rheumatoid arthritis.

Elan has also resumed research to develop treatments for Alzheimer's. Last month it announced that U.S. authorities had awarded seven patents for research being conducted jointly with Wyeth Laboratories of Madison, New Jersey.

[kingofthehill]

Picture of Kelly Martin in weblink)
Elan up 6pc as Biogen merger rumour mounts


Asked last month if the companies were in talks, Elan chief executive Kelly Martin said: 'We must have 50 discussions a day with Biogen'.

SHARES in Elan were up 6pc in the US last night on speculation that American company Biogen may mount a friendly takeover of it, despite denials from the Irish company that it was in merger talks.

Asked to clarify its position by the Irish Stock Exchange, Elan said it was "not in negotiations or discussions with Biogen Idec regarding any form of merger or business combination between the two companies".

The Sunday Tribune had quoted US sources as saying that Biogen was looking at an €8.5bn ($10.6bn) all-share offer and that a deal could be struck within nine months.

The two companies are partners in developing multiple sclerosis treatment Antegren.

In the US, Elan shares closed up 6.1pc to $22.56, while in Dublin the shares closed up almost 6pc at €17.95.

Biogen Idec and Elan are developing Antegren for use in multiple sclerosis, Crohn's Disease and other diseases that involve the immune system.

Analysts expect the two companies to get clearance from the US Food and Drug Administration to sell the drug for use in MS cases in November.

However, the partnership agreement between Elan and Biogen blocks the US company from making a hostile bid for the Irish company.

One London-based analyst, who did not wish to be named, said the attractiveness of Elan to any company other than Biogen is limited as the US company has the right to buy the rights to Antegren in full, if Elan is bought by another company.

Biogen Idec's chief executive officer, James Mullen, said in an interview in July that the company does not have any plans to seek a merger with Elan.

Asked last month if the companies were in talks, Elan chief executive Kelly Martin said: "We must have 50 discussions a day with Biogen.

"We're equally committed to making sure Antegren as an asset is going the right way," he said, according to Bloomberg. "Those are our discussions. Launching Antegren is a very complicated task."

Mr Martin said his responsibility was to create value for patients, employees and shareholders.

"We can create an enormous amount of value if we stay focused on what we have," he said. "The ability for us to create value as a stand-alone entity is almost endless."

In a research note Goodbody analyst Ian Hunter said the two companies were in regular contact as they discuss how to account for a 50:50 split in Antegren profits.

Charlie Weston

http://www.unison.ie/irish_independe...385&issue_id=1 1561

[kingofthehill]

Buy Volume: 402,184 shares
Sell Volume: 47,184 shares

I would call that a strong bias!

Dont have similar breakdown for Dublin but they traded 255,362 shares, not very busy.

15 mins ago NY was 2.5m buy, 2.2m sell.

By the way, next week, the 26th will be the 5-month anniversary for the Antegren filing!!!!

Only a matter of time now!

[kingofthehill]

there is alot of info about Elan at this link

http://www.tixx.com/ECTRIM%20reportStillorgan1.htm

[kingofthehill]

this should be the start of covering the 18 million shares short Elan , approval comes next month or sooner, this is the most exciting Biotech out there its a freaking bargin price.. 2 years ago the stock was $65.00

[kingofthehill]

http://www.businessweek.com/

NOVEMBER 1, 2004
NEWS: ANALYSIS & COMMENTARY

Antegren: Hype Or Hyperdrug?
Biogen's much-ballyhooed MS fighter is getting positive signals from the FDA

Multiple sclerosis sufferers have not benefited from a new type of drug for more than a decade. That may change by Nov. 26, when the Food & Drug Administration is expected to decide whether to approve Antegren, a dramatically different treatment for the chronic disease. The drug was co-developed by Biogen Idec Inc. of Cambridge, Mass., and Ireland's Elan Pharmaceuticals Inc.

Expectations are running high for Antegren, particularly on Wall St. Biogen Idec's stock is up 57% since January, to about $57 in mid-October, while Elan has soared from $5 to $24. Although most of the gains came early in the year, glowing analysts' reports in recent weeks have also fueled rumors that Biogen might buy its partner. Morgan Stanley sees annual sales surpassing $2 billion by 2008, while market researchers Decision Resources Inc. says Antegren "will radically alter the multiple sclerosis market."

Will Antegren live up to the hype? Plenty of biotech drugs have generated outsize expectations only to fizzle. And Antegren faces challenges, not least whether insurers will pay the drug's projected $20,000 annual cost, nearly double that of current treatments.

What's more, doctors don't know if the drug works better than existing treatments. In an unusual move, Biogen and Elan decided not to release data from two large clinical trials until after the FDA rules. Although the drug did show promising results in a mid-stage trial, that study lasted only six months and involved a small number of patients. "We don't know anything about the long-term safety of the drug, or how it compares with existing therapies," cautions Stephen C. Reingold, research head of the National Multiple Sclerosis Society.

The FDA has sent positive signals, though, granting Antegren a rapid review last May after looking at one-year results from the Phase III clinical trials, designed to run two years. Biogen says it wants to hold off releasing that interim data so as not to prejudice the final outcomes of the trials, due to end early next year. But Dr. Burt A. Adelman, head of research and development for Biogen, says the FDA typically doesn't like to base approvals on interim data. "They said these results were very striking."

MISSING EVIDENCE
Antegren also seems promising because it is the first drug designed to block the out-of-control immune cells that cause MS. These cells attack the coating that surrounds and protects nerve fibers. Over time, nerve cells are destroyed, and patients experience symptoms ranging from fatigue and blurred vision to poor muscle control and speech impairment. A patient can go weeks, months, or years without a relapse, but about 50% of sufferers end up progressing to permanent disability.

The most common treatments, led by Biogen's own Avonex, are based on interferon, an inflammation-fighting protein a patient self-injects with a needle daily or weekly. The interferons fight inflammation and reduce relapses, but they haven't been very effective in delaying progression of the disease, and they can cause debilitating flulike symptoms. By contrast, Antegren, a targeted antibody that blocks immune cells from reaching the nerve fibers, appears to have few serious side effects. It is given intravenously just once a month. Data from the mid-stage trial indicated that Antegren reduces inflammation and relapses better than interferon.

But so far no evidence exists that Antegren can slow the progression of MS. That's what doc- tors want, says Dr. John R. Richert, head of the immunology department at Georgetown University Medical Center in Washington: "The most important information is whether it [delays] disability progression. If it doesn't, I don't really care what it does to [inflammation] or the relapse rate." Given the side effects of interferon, however, patients may beg to differ.
By Catherine Arnst in New York

[kingofthehill]

Live In Play


25-Oct-04
08:35 ELN Elan Corp: Class action suits could be settled today, which would be likely positive for stock -- Piper (25.32 )

Piper Jaffray believes the outstanding shareholder class action lawsuits could be settled today, which would likely be a positive for the stock. The lawsuits are consolidated for review in Judge Berman's courtroom in the District Court for Southern New York and, according to the docket listing, the final hearing on this trial is set for 2pm ET today. Firm believes that the SEC settlement could be announced concurrently with the class action settlement; conclusion of both of these outstanding investigations will relieve an overhang on the stock, and we expect the stock to trade well ahead of and through this news.

[kingofthehill]

Good news....
Elan settles class action for $75M, settles SEC probe

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

CBS MarketWatch MarketPulse
4:59 p.m. 10/25/2004 By Heather Wilson


SAN FRANCISCO (CBS. MW) -- Elan Corp. (ELN) said late Monday that it has agreed to settle a shareholder class action lawsuit and a Securities and Exchange Commission investigation. The company will pay $75 million to settle the class action suit, of which $35 million will be paid by its insurer. The settlement is subject to court approval.

[kingofthehill]

this company doubled thier position in Elan from 12 million shares to 21 millions shares

http://www.uk-wire.com/cgi-bin/articles/200410261711015052e.html