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if Elan get this ALZ drug to market like i expect, we are talking to the moon stock price.........
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King, you're the expert on drug companies around here... Tell me what you think about these guys. They supposedly have a new drug called Tripeptofen that they claim could be huge.
I'm skeptical, but intrigued at the same time. Here's a link to their website...
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I have no idea but i will ask someone for you
on our favorite subject .........
BIIB has more Tysabri inventory than prior to original launch.
BIIB has greater production capacity than prior to original launch.
Tysabri has a greater documented efficacy ratio than prior to original launch.
Tysabri is much more well known than prior to original launch.
ELN has a much cleaner balance sheet than prior to original launch.
There are more infusion centers online than prior to original launch.
There is more insurance coverage available than prior to original launch.
We were trading at $27+ prior to original launch.
This is so simple.
swiped fromyahoo message boardComment
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I am on the record here .. I AM POUNDING THE TABLE FOR THOSE THAT FOLLOW ELAN TO BUY NOW THE NEXT 2-8 WEEKS WILL SEE US FLY ....
OK MERRY CHRISTMAS
TYSABRI IS GOING TO BE HUGE ....
READ WHAT THE CFO OF BIOGEN SAID YESTERDAY
Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer
"Well it's great to be here. I can tell you it's been a very interesting year for Biogen IDEC. This slide
is sort of interesting because at this time last year, we were doubling our sales force in neurology.
We had just finished communicating the one-year's data to the public in TYSABRI and we just
received TYSABRI approval. So it's been quite a year, as you can imagine. That followed with the
launch of TYSABRI and it was really, as you may recall, quite a sensational launch. We had, after
less than 3 months, 5,000 patients on drugs, 15,000 or more – actually more than that in the queue
and that's in the context of the U.S. market where there's about 200,000 patients on drugs. So less
than 3 months, already had a 10% market share of the very interesting MS market. So it was quite
a sensation. But unfortunately, a couple of new data points came up, a couple of events came up
in the MS community where we had to suspend the drug because these were safety issues that
came up that we had not seen in the clinical trials. And so we knew we had to pull the drug back,
do the research on what had happened to all the trial patients and get physicians to prepare a
proper risk-benefit profile for the drug."Comment
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BUY!!! BUY!!! BUY!!!Comment
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Kellog says:
“Regarding a panel meeting for the FDA, we’re just waiting to hear if there will be one, we haven't requested, its really up to the FDA, however its been our expectation that there will be one. If you consider the amount of interest that there has been in Tysabri, and the amount of safety data that’s been accumulated and what the label should read and what kind of risk-mapping should be applied”
* Interesting – in response to a question about dialogue with the FDA re the sBLA the response was “there is always dialogue, so we are always talking from one topic to the next…some of the dialogue has been to redosing in the clinical setting, in the short term”…
Yet later when asked about dialogue re the Rituxan sBLA the respose was there was "no dialogue at all".!!
*Hmmmmmm
The question is how much capacity we have in RTP and how much inventory. In terms of capacity (over to Oscar?) - capacity is at 70,000 patients but with minor tweaking of the process that number is at about 100,000, and this is just the current process as it stands, … we have been working on a higher titre process and increasing that as multiples of about three at this point.. So you can imagine that’s gonna work in our favour but that’s gonna take some time before we actually get to that process.
In terms of the level of inventory that we have for Tysabri currently right now, we estimate that we currently have about 150,000 doses that are available should the product come back to market…(back to Peter) and we begin further production next year.
Later, in discussion about market research about Ty in the MS market, … “everybody including ourselves were a little bit stunned about the level of interest that came in….”
An interesting comment – in response to a question about the future risk of PML, what is the anticipated response of the companies, the agency? Kellog states “that is probably the heart of a lot of the discussion that is going on right now, …..blah, blah, blah, …what you do when it does resurface and how you handle it….the FDA is quite experienced with that (ie risk/benefit)”
The other guy then talks about the risk management/ label issue and someone in the audience says about “a plan, intervention, an 800 number..” and Kellog states (clearly) “that’s the kind of thing that’s being discussed right now”
So, what did I get from that?
Lots, including they can do 100,000 patients at the current plant and are gearing up for 3x that in the future. By the way, that’s PATIENTS, not doses!
So yesterday Biogen told the world that they are investing and planning for 300k patients!!! At present prices that’s 300k x 23k = $6.9b
(and some ANALysts are still wondering IF Tysabri is coming back!!)
And theyre working on the 800 number.
Could I suggest 1-800-DONT-DO-COMBO
(lots of egg on face in W/S very soon! WAKE UP!!)Comment
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Revenge will be mine sayeth the Vulcan... It's going to be a fun ride! Hahaha!Originally posted by kingofthehillComment
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King says things are cooking real well ...great news could be a mere few days awayComment
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Something seems to be up. Up .65 today.Originally posted by kingofthehillComment
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Journal: Monday, December 05, 2005
• Buy 400 shares of Elan (ELN, news, msgs) at market.
All-Star Team Lab Performance
Round 13 $106,353.26
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Bullish on Elan after FDA action
Elan (ELN, news, msgs) has benefited from some good news. The Food and Drug Administration (FDA) granted Tysabri priority review status, which means the FDA will complete its review in six months instead of 10 months. The four extra months of sales will have a big positive impact on their 2006 revenues, but the really good news is that by granting a priority review the FDA has acknowledged that Tysabri addresses a big unmet medical need. In other words, there are lots of Multiple Sclerosis patients for whom all other drugs have failed, and who may benefit from Tysabri. I think this means that the chances of Tysabri returning to market next year are high.
At the start of this Strategy Lab round, the FDA had not yet accepted Elan's data, but after reviewing the clinical trial data I felt confident enough to initiate Elan as a small position. With the recent news, my confidence has grown, and I am increasing my position in Elan.
Not missing a second chance
I have found that the most profitable investment decisions I've ever made are not the first buy decisions, but the follow-on buys. From watching thousands of investors trade at Marketocracy, I've learned that many people are not comfortable adding to a winning position because they don't want to pay a higher price for the second block of stock.
I think that's a big mistake. When the market starts to tell me I'm right about a stock, I think it’s smart to add to that position. But I also don't want my portfolio to become overly dependent on a single stock. Adding 400 shares of Elan will make the position about 10% of the portfolio, which reflects my confidence in the stock.Comment
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The Times December 07, 2005
Elan keeps chief on board with improved contract
By Richard Irving
THE board of Elan, the Irish drugs maker, is to approve a new open-ended contract today for Kelly Martin, the chief executive.
The new agreement will tie the former investment banker to the company ahead of the expected relaunch of Tysabri, its multiple sclerosis treatment, next April. It will replace a three-year fixed contract that expires at the end of the month.
According to the latest report and accounts, Mr Martin earned just over $834,000 (£478,000) in salary last year. He also received 200,000 stock options with a weighted strike price of $7.47 in lieu of an annual cash bonus, which he waived.
Under the new deal, Mr Martin’s basic pay and benefits package is understood to be broadly in line with current levels. However, the new contract will include more performance-related share options, reflecting the board’s determination to ensure that Mr Martin oversees the relaunch of the firm’s most promising drug.
The company pulled Tysabri from pharmacy shelves in late February amid fears that the drug might be linked to progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain disease.
Elan has since reviewed the case studies of three patients who appeared to contract PML while taking Tysabri, as well as additional data on more than 3,500 patients who had participated in trials of the treatment.
The information, which has since been lodged with the US drug regulator, appears to strengthen claims by the company that Tysabri is the most effective treatment available for multiple sclerosis.
Scientists have collated clinical trials over two years showing that 67 per cent of patients taking Tysabri experienced a reduction in debilitating relapses. The results are slightly better than Elan’s initial tests, which covered one year and considerably better than some analysts had hoped for.
The US watchdog has vowed to give Tysabri a priority review and a decision on its future is due next March.
It is expected that, because the latest data is better than that supporting Tysabri’s initial filing for approval, regulators will be minded to approve the medicine.
Current talks between regulators and Elan are understood to be focusing on what the company must do to ensure that doctors prescribing the treatment recognise immediately any symptoms that might suggest the early onset of PML.
Kelly Martin said yesterday that it was inconceivable that the drug would not be reapproved. He expected more than 25,000 patients who had pre-registered their intention to switch to Tysabri at the time of its launch in November 2004 to make the switch immediately the drug becomes available, despite the bad publicity.
The company expects to break even on Tysabri, which will sell for $23,000 per person per year, once it has signed up 20,000 patients.
Mr Martin added that a decision from European regulators was expected next June or July.
Copyright 2005 Times Newspapers Ltd.
This service is provided on Times Newspapers' standard Terms and Conditions . Please read our Privacy Policy . To inquire about a licence to reproduce material from The Times, visit the Syndication website .Comment
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Investors in Irish biotech Elan (NYSE: ELN - News) are probably hoping that the second time's the charm. After some extensive work, the company and its partner Biogen Idec (Nasdaq: BIIB - News) have resubmitted their troubled multiple sclerosis drug Tysabri for FDA approval.
The two companies received a priority review designation from the FDA. As a result, their application will be reviewed more quickly, potentially shaving as much as four months off the normal time. The reason why the companies got this priority review for Tysabri shouldn't be ignored: The drug satisfies a significant unmet clinical need.
Readers without direct experience with multiple sclerosis may not appreciate just how debilitating it is, or the impact it has upon people's lives. There are few good options available for treatment, and patients don't always respond to them especially well. And for whatever safety problems there might be with Tysabri, the drug was quite effective for some patients.
We at The Motley Fool have talked a lot about Tysabri and the safety issues, and there's no need to rehash that. (The drug has been linked to a few cases of the rare neurological disease PML, or progressive multifocal leukoencephalopathy.) The question now is how the FDA will respond. Will the companies' newly submitted data, safety assessment, and revised labeling be good enough for approval?
It's a tough call. On one hand, I'm sure the FDA wants to be sensitive to the needs of some very sick individuals, many of whom would likely be willing to assume whatever slight (but serious) risks go with Tysabri in exchange for the possibility of a better quality of life. On the other hand, the FDA has been a tough customer of late with some other drugs -- potentially holding up Bristol-Myers' (NYSE: BMY - News) experimental diabetes drug Pargluva for years by requesting more data.
FDA approval is now the name of the game. Even if the FDA slaps a serious black-box warning label on the drug, once it's approved, doctors have considerable latitude in how they prescribe it for patients. And considering that Tysabri can cost more than $20,000 per patient per year (and there are about 350,000 MS patients in the US), even capturing 10% of the market would be a very meaningful opportunity for Elan.
I said before that I thought the safety concerns would take away Tysabri's chance to be a blockbuster (generally defined as $1 billion in sales). Maybe I'll be right, maybe I'll be wrong. I'd be more than happy to write a follow-up piece a year from now saying I was wrong to doubt Tysabri's potential -- not because it means that Elan shareholders made money, but because it would mean that a lot of patients are seeing some real improvement in their lives. In any case, Elan shareholders should buckle their seatbelts. The next few months are apt to be a heckuva ride"Comment
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up 50 cents todayComment
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