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Picked some up in the early dip at the open at 22.98.
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copied from yahoo board on ELN
This is all I can think of as a first pass.
April - Alz conference in Montreal
May- SEC news
May - Crohn's Induction Trial announced
May - first-qtr earnings release, along with Antegren launch cost estimates
May - BLA filing of Antegren/MS with FDA
Jun - Filing of Antegren/MS in Europe
Jun - Prialt FDA filing
Jun - EPIL II retirement (or is it III??)
Jul - Fast Track review approved by FDA for Antegren/MS
Jul - IND Filing for revised AN 1792 vaccine (I think this will be announced just before the Alz Conference)
Jul - Alz Conference in Philadelphia***THIS COULD BE HUGE*****
Jul - rolling filing with FDA - BLA for Antegren/Crohns
Aug - 2nd qtr earnings release
Oct - R&D day
Nov - 3rd Qtr Earnings and guidance
Nov - Prialt Approval
Dec - Antegren/MS Approval (yeah, baby!)
Dec - Antegren RA Phase II results (maybe January, however)Comment
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CLICK here for a very good report on Elan by Morgan Stanley
also check out this site www.tixx.com/elan.htmComment
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FYI
Elan Sets Date of May 13 for First Quarter 2004 Financial Results, and June 17 for the Annual General Meeting; Elan Announces Filing of 2003 Annual Report on Form 20-F with SEC
4/29/2004 2:30:00 AM
DUBLIN, Ireland, Apr 29, 2004 (BUSINESS WIRE) -- Elan Corporation, plc today announced that it will report its first quarter 2004 financial results on May 13, 2004, before U.S. and European financial markets open. The results announcement will be followed by a conference call at 8:00 a.m. Eastern Time, 1:00 p.m. British Summer Time, with the investment community to discuss its first quarter 2004 results. This event will be webcast live and can be accessed by going to the Investor Relations section on Elan's website at www.elan.com. Following the live webcast, an archived version of the call will be available for replay for 24 hours. The replay number is 800 633 8284 or +1 402 977 9140, and the reservation number is 21194057.
Elan will hold its Annual General Meeting at 10:30 a.m. British Summer Time on June 17, 2004 at the Shelbourne Hotel, St Stephens Green, Dublin 2, Ireland.
Elan has filed with the Securities and Exchange Commission its Annual Report on Form 20-F for the fiscal year ended December 31, 2003. The 2003 Annual Report on Form 20-F is available on the Investor Relations section of Elan's website at www.elan.com. Elan previously announced its unaudited U.S. GAAP financial information for the year ended December 31, 2003 on February 18, 2004. Elan has conducted a standard post balance sheet review and updated its original estimates based on more recent information received. The impact is to reduce shareholders' equity at December 31, 2003 by $6.1 million and increase Elan's diluted loss per share for the year ended December 31, 2003 by $0.01.Comment
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Biogen Idec speeds building of plant
By Penni Crabtree
UNION-TRIBUNE STAFF WRITER
May 1, 2004
Biogen Idec said yesterday it is speeding construction of its $400 million Oceanside drug manufacturing plant to meet anticipated demand for its multiple sclerosis drug Antegren.
The Cambridge, Mass.-based biotechnology company, which maintains a large research campus in San Diego, plans to manufacture some of the drug in Oceanside if it is approved by federal regulators.
In February, Biogen Idec announced it would submit Antegren for government approval a year ahead of schedule because of strong results achieved in on-going clinical trials. Analysts speculate that it could be approved as early as this year.
The 500,000-square-foot manufacturing facility, along with a new $178 million research campus in San Diego, make up the West Coast hub of Biogen Idec, the third largest biotech in the world. The company was formed in November from the $5.8 billion merger of San Diego's Idec Pharmaceuticals and Massachusetts' Biogen.
As part of the accelerated plant construction schedule, the company plans to close its 70,000-square-foot Oceanside manufacturing facility this summer. The pilot plant, which made drugs used in clinical trials, employs about 150.
Amy Brockelman, a spokeswoman for Biogen Idec, said most of the 150 employees will be offered jobs in the new Oceanside manufacturing facility, which already employs 250, or at company plants in Massachusetts or North Carolina.
Brockelman said construction of the Oceanside plant should be completed by the end of the year. It is expected to take up to two more years to complete the necessary licensing and inspections required for the plant to be fully operational.
The company outlined plans for the Oceanside facility during a conference call to discuss its first quarter financial results. Biogen Idec reported a loss of $41 million, or 12 cents per share, compared with a profit of $41.2 million, or 24 cents, generated a year ago.
Excluding merger-related charges, the company's earnings per share were 40 cents, up from 24 cents last year.
Biogen Idec reported revenue of $542 million, up from $437 million on an adjusted pro forma basis in the year-ago quarter.
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Penni Crabtree: (619) 293-1237; [email protected]Comment
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Hey, King of the Hill....or uh..Mountain, after that call on osip...
It looks like you are big on medical stocks and have a keen intuition when it comes to them. So let me run one by you that I have come across.
This little find of mine is FONR, trading at $1.34.
FONR makes a standup MRI unit that seems to have interested a lot of doctors. Sales have doubled so far this year and the outlook is not bad. The earnings announcment comes out on 5/15 and, chances are, is it will be a very good one.
I am not a medical tech expert and definitely a stock expert, but this looks good to my untrained eye. What do you think? Any thoughts anyone?
5/15 is ten days away so there is time to investigate and I'll be doing just that.
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CAll options on ELN
Anybody consider buying some options on ELN, i think it would be a good move, get them cheap right now on a $23 strike.Comment
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i had trouble trying to post here the last week it kept logging me out .. but anyway here is the weeklyy update
BIG BIG NEWS
Press Release Source: Elan Corporation, plc
Elan and Biogen Idec Announce Webcast of ANTEGREN ENACT-2 Maintenance Data to Be Presented at DDW on May 19, 2004
Friday May 7, 8:30 am ET
DUBLIN, Ireland, CAMBRIDGE, Ma. & SAN DIEGO--(BUSINESS WIRE)--May 7, 2004--Elan Corporation, plc and Biogen Idec today announced that the companies will host a joint discussion of the ANTEGREN® (natalizumab) ENACT-2 data (Crohn's disease maintenance trial) to be presented at Digestive Disease Week ("DDW") during the Late-Breaking Abstract Symposium on May 19, 2004 beginning at 8:30 a.m. Central Time. Following the symposium, the companies will host a joint discussion of the data at 11:00 a.m. Central Time, 12:00 p.m. Eastern Time, 5:00 p.m. British Summer Time with the investment community.
The webcast announcement wording is the KEY to all of the following speculation:
".... Following the symposium, the companies will host a joint discussion of the data at 11:00 a.m. Central Time, 12:00 p.m. Eastern Time, 5:00 p.m. British Summer Time with the investment community."
here is what a fellow ELn invesotr thinks ...and I agree..
The key phrase is 'WITH THE INVESTMENT COMMUNITY!!!!' Does anyone here think they are going to say to the investment community what they have already said - 'WE ARE STILL DISCUSSING THIS WITH THE FDA' or 'WE DO NOT ANTICIPATE AN EARLY FILING?'
Not likely. Why would they highlight bad or no news like that?
There WILL be a filing announcement - the key will be is filing before or after the new Induction trial. The Companies are going to explain this on the 19th, one way or another. Again, my guess is the decision will be FILE NOW, otherwise why have a webcast?
As an aside, we don't even know where the webcast will be from - apparently NOT from the DDW, or will it be??? If it is at the DDW site (unlikely, IMHO) then it would be directed at clinicians. But they have clearly said 'investment community.'
At any rate, here is the outline of my reasoning on this:
1. I speculate that ELN/BIIB met with the FDA earlier this week. [Remember that Morgan Stanley (who are very close to ELN management) says that the FDA meeting re: Crohns would be within the 2-month period from 11Apr-11Jun. Recall also that Elan is managing the Crohn's program, so they are closer to it than BIIB.]
2. Further to that, my guess is that the FDA told them:
'You CAN file for maintenance and then amend the NDA if the induction trial proves successful. This is up to you.'
3. Rather than immediately announce a filing, the companies are reviewing the FDA position and most importantly a Crohn's filing effect on the MS Filing, and any other relevant information (off label usage potential, plant capacity, etc, etc, etc).
4. After this ELN/BIIB review over the coming week, they will make a decision on when they will file.
5. IF they make the decision to file now, they will announce it on the 13th, IMHO, right before the quarterly CC (just like they did with the MS filing on 18 Feb.)
6. If they do not announce it on the 13th, then I suspect the Companies have decided to delay the Crohn's filing (because of possible effects on the MS filing).
7. An alternative explanation is that the meeting with the FDA concerning Crohn's filing has been scheduled before the 19th, and the Companies know they will have a decision on file/no file by the 19th. Hence the explanation to the investment community.
8. Another explanation might be that they announce the Antegren MS filing, and then highlight possible off-label usage fro Crohn's. They clearly say in the PR that it will be a '...joint discussion of the data (the Crohn's maintenance data)..' so I think it unlikely that they will talk about MS filing. Also, for companies to publicly encourage off-label usage would be ethically wrong (IMHO) and would royally piss-off the FDA (again IMHO).
All the above is pure speculation, but the webcast is a great development.Comment
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day to day i dont know what will happen with price per share .. but here is what i do know ..buying this stock will make you much more money than any other stock that i know of by the end of thsi year..the company is still out of favor with mainstream writers...they only know one biotech DNA
this is $40.00 by year end based upon the upcoming FDA fastrack approval
READ THIS http://www.wchstv.com/newsroom/healt...tml#transcript
“There are about 400,000 Americans with MS, and about 200 people are diagnosed with MS every week.
Worldwide, MS affects about 2.5 million people”
That’s an $8 billion market in the U.S. (400,000 * 20000) and a $50 billion market worldwide (2,500,000 * 20000), for a product priced at $20,000 per year. Antegren should be priced close to that mark. A recent post by Azernie (36178
shows the average cost of the existing therapies at about $16,000, with Rebif costing about $19,000. I think Kelly Martin hinted about something close to 20% above existing therapies. It doesn’t really matter. I just want to demonstrate the potential for Antegren over and above existing market penetration.
Current therapies, Avonex, Rebif, Copaxone, Betaserone, have totalled annualised sales of close to $4.5 billion for the last quarter. In my opinion, this low level of penetration is because of limited efficiency, regular painful injections, and serious side effects. In fact, the number of dropouts from existing treatments is estimated to be around 100,000. That’s a market of $2 billion on its own.
Antegren appears at LEAST twice as efficient as the existing treatments. It is administered once a month, and has an excellent safety profile over 4 years of studies. Side effects have been no different than in the placebo group in all cases.
I can’t fathom why Antegren wouldn’t completely cannibalise the existing market. This is a very serious illness. Patients and neurologist can’t afford to play games with this. There’s only one decision to make.
IMO, Antegren will also expand the penetrated market potentially by multiples. It wouldn’t surprise me if Antegren exceeded annual sales of $10 billion for the MS indication alone.
The mind boggles when you think of the many other possible indications for this product. IMO, it’s a shoe in to be the first line treatment for many auto immune diseases.
Elan and Biogen have no chance of staying independent, unless they play this potential down while they grow the PPS. TGFTSec!Comment
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I hope you are right. But honestly, you don't know this. You can only assert this. The fact is, sometimes there can be a drastic change of perspective due to some unforeseen factor that leaves bagholders wondering why. And often, large moves can happen before the news comes out. Stubbornly thinking you are right about a stock will eventually catch you out. If you are well diversified, and factor this into your trading plan, then GREAT. But any traders out there following your advice and putting a large chunk of capital into one or a few stocks might well find themselves deep in the emotion of regret should ELN do the type of price drop back in '02. Don't throw caution to the wind and risk it - 'cuz it ain't worth it.Originally posted by kingofthehill
Friday's SHS was the warning sign for today's drop.
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there is alot more to this unique stock play than charts...if i read charts i would have never bought the stock at $5.00 and held ...when main stream news picks up on what We have here ..the stock will double
[P06.082] Single-Patient Study for the Emergency Use of Natalizumab (Antegran) in the Treatment of Pediatric Multiple Sclerosis
Shehzad Choudry, Shane Maxwell, Douglas R. Jeffery, Wisnton-Salem, NC, Michael Panzara, Boston, MA, E. Steve Roach, Winston-Salem, NC
OBJECTIVE: To assess the safety and efficacy of monthly IV doses of natalizumab (Antegran) administered to a 5-year old patient with aggressive multiple sclerosis (MS) BACKGROUND: Pediatric MS is uncommon and there have been no controlled trials of standard immunomodulatory therapy. The present report describes a 5 year old patient with onset at 18 months treated with natalizumab (Antegran) as rescue therapy. Antegran is a humanized monoclonal IgG4 antibody to the a4 integrin. The patient had an uncomplicated aseptic meningitis at 15 months. Three months later she developed a right hemiparesis and was diagnosed with acute disseminated encephalomyelitis. MRI scan showed multiple white matter lesions. Three months later she suffered a partial transverse myelitis and her MRI scan showed more new lesions. She then developed ataxia and subsequently a bilateral optic neuritis accompanied by further changes on MRI. Oligoclonal bands were negative but extensive evaluation failed to reveal a more likely diagnosis and the diagnosis of MS was later confirmed by brain biopsy. She was started on interferon beta-1a and titrated up to 21 mcg IM twice weekly. Despite treatment she continued to show evidence of aggressive inflammatory disease and required frequent IV methylprednisolone (MP) and eventually cyclophosphamide. She tolerated treatment poorly and progressed despite therapy. She suffered a severe right optic neuritis with complete loss of vision in her right eye and a cervical transverse myelitis. She was treated with IV MP and plasma exchange with only minimal recovery. At this point she remained quadriparetic and blind from her MS. She began treatment with Antegran on an emergency basis approved by the FDA and the IRB. DESIGN/METHODS: Given her age and weight, she was initially dosed at 3 mg/kg monthly for four months and later at 6 mg/kg to achieve adequate drug serum concentrations. Therapeutic effect was assessed by MRI, relapse frequency, and EDSS. Safety assessments included exams, vital signs, adverse event monitoring, and laboratories as well as monitoring pharmacokinetics. RESULTS: Following 29 weeks of therapy she has continued to improve clinically and is now fully ambulatory. Vision remains severely impaired with only partial recovery of vision in her right eye. MRI scans have shown a marked reduction in gadolinium enhancement and in new lesion formation with minimal disease activity. She developed an apparent IFN related hepatitis resulting in the cessation of IFN therapy. No elevation of liver function tests or other drug related adverse events has been apparent on Antegran alone. CONCLUSIONS: The use of Antegran has been safe and effective for 29 weeks in a five year old patient with aggressive MS who failed to respond to standard immunomodulating therapy. Supported by: Biogen, Idec, and Elan Pharmaceuticals.
Category - MS and Related Diseases
SubCategory - Therapeutics
Thursday, April 29, 2004 3:00 PM
Poster: Multiple Sclerosis: Therapeutics I (3:00 PM - 7:00 PM)Comment
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Poor little girl with MS. Prayers for her.
It'd be great if the stock doubled for you and all who ride it. That would be an awesome pick, and I'd be at the front of the line to say good job.
Forgive me if I'm thread crapping, but most successful traders, if not all, will tell you, "Don't marry a stock and ignore what the market tells you" or the chart tells you. Every stock is unique, that's for sure. This stands out as having reason to be bought, but the market tells me that there is reason to be cautious with this stock.
Consider these questions:
What's the worst possible news that could hit this stock?
What would happen to the stock price if that news came to pass?
Where is support on the chart? And more importantly, where are the holes on the chart. The gap below 10 is a big fat glaring irrefutable hole. Sure, it was a runaway gap and the stock could turn into a TASR, but if bad news hits it, that gap may get filled.
Are you prepared to ride it down to the gap and expose yourself to that much risk?
These questions apply to any stock we trade. If you're happy with the risk then excellent. Everyone has different risk/reward tolerances. If a 50% or worse loss is acceptable to someone and they have factored it in to their game plan, then Great! I throw these thoughts out there so that people know that a 50% loss from current levels is at least a possibility as of today.
Peace.
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Spike I welcome and truly appreciate your input ..the next 30 days will be huge for this company, I'm betting on the integrity of the new management and the known trial results.
best of luck to all the conference call is Thursday
today was crazyComment
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here is the early report.. I will post more after the conference call
Reuters
UPDATE - Elan trims Q1 loss, says drug filings on track
Thursday May 13, 5:02 am ET
By Kevin Smith
(Updates with further analyst comment, background)
DUBLIN, May 13 (Reuters) - Irish drug maker Elan Corp Plc (Irish:ELN.I - News) narrowed its loss in the first quarter after cutting costs and selling off assets and confirmed on Thursday it was on track to file applications for its flagship drug Antegren.
The net loss narrowed to $67.1 million, or $0.17 per share, from a pro forma $140.2 million, or $0.40 per share in the first quarter of 2003, while revenues from retained products rose seven percent to $75.4 million, the company said.
Former high-flier Elan, which has clawed its way back from a collapse in its stock in 2002, said it was on schedule to file Antegren for multiple sclerosis and Prialt for chronic pain with U.S. and European regulators in the current quarter.
It also said discussions were continuing on a potential filing for Antegren as a treatment for Crohns disease.
Analysts gave a broad welcome to the results, but had hoped for more details on Antegren's progress and potential.
"In general terms the numbers were good but in a way the day-to-day operational performance is dwarfed by the Antegren opportunity and there was no real newsflow on that," said Peter Frawley, analyst at Dublin-based Merrion Capital.
He said further details could emerge from a conference call with the company later on Thursday.
Elan, which has raised $2 billion from an asset sale programme to pay down debt, has made a dramatic comeback since 2002 when it was hit by concerns about liquidity and a probe by U.S. authorities into its accounting practices.
Shares in the company were up 3.6 percent at 17.20 euros by 0840 GMT on a moderately positive Dublin bourse, though dealers said the price was largely catching up with the previous close in New York, where the stock is mainly traded.
The share price, which plunged to less than two euros in 2002 from a 2001 peak of nearly 74 euros, was catapulted to two-year highs in March by news Elan was ready to seek regulatory approval for Antegren as a treatment for MS more than 12 months ahead of schedule.
If approved by the U.S. Food and Drug Administration (News - Websites) (FDA), Antegren -- which Elan is developing with Biogen Idec (NasdaqNM:BIIB - News) -- could be on the shelves by early 2005 in a hotly-contested market some analysts estimate could be worth more than $6 billion by 2010.
Investors also have high hopes for Antegren as a treatment for Crohn's disease and for pain drug Prialt, both of which could also hit the market in the first quarter of 2005.
Elan's total first-quarter revenues fell to $159 million from $224.7 million due to its disposal programme, while total operating expenses were reduced by 29Comment
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