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This is killing companies like mine FLU SHORTAGE


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Chiron Corp (Emeryville, CA), which was expected to manufacture half of the flu vaccines in the U.S. this year, announced it will not manufacture or sell any Fluvirin doses of the vaccine after British health authorities suspended the manufacturing license for the company's Liverpool, England factory. The three-month suspension was due to failure of the plant to meet U.K. manufacturing standards. The U.S. Department of Health and Human Services (Washington, DC) will send a team of experts to inspect the plant and discuss the possibility of releasing some of the vaccine already manufactured. Both Chiron and its primary distributor of the Fluvirin vaccine, Henry Schein Inc (Melville, NY) cut their earnings forecast following the announcement. Schein will still distribute MedImmune Inc's (Gaithersburg, MD)

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Elan is the best kept secret on the NYSE, just buy and hold the stock you will make the best return of any pharma stock. FDA approval next month

http://www.elan.com/research_development/Antegren/default.asp

Well I am not the expert in stocks I would say it is a safer invesment with pharma stocks

But look at Merck their stocked plunged after the Vioxx issue, even Chiron with this flu shortage I believe dont quote me on this is plunged $16 a share

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NOT GUTS >>NO GLORY... you guys are young enought to take a shot.. this is the play of the year.. you can repay me with lap dances at scores

this is an article you would never see.. Elan is an Irish Pharma company this article was in the Sunday Irsih Times..

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!

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