ahemmm 9.86
MY PICK IS ELN
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Originally posted by WebsmanAhhh, there you are Spike. I was hoping you'd bring me back down to earth.lol
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yeahhhhhhhhhhhhh babbbbbbbbbbbbbbbbbbbyyyyyyyyyyyyyyy
Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI(R) in Multiple Sclerosis
Thursday November 17, 4:44 pm ET
CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 17, 2005--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA).
The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On September 26, 2005, the companies announced they had submitted the sBLA for the market re-entry of TYSABRI for MS and requested Priority Review.
The sBLA for TYSABRI in MS includes:
final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS;
integrated safety assessment of patients treated with TYSABRI in clinical trials; and
revised label and risk management plan.
"We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS."
"We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We will continue to work closely with the FDA as they review the filing so that TYSABRI can be made available with an appropriate benefit-risk profile."
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Excellent!
This is indeed great news for ELN, though I don't the AH action really reflecting it. Of course, this news is to be expected, just as Tysabri is expected to be back on the market, given that ELN is trading at more than $5. This news definitely increases my interest in the stock, though, and if it's still trading at $10 after the initial euphoria dies down, I may even pick up some shares again. When Tysabri is back on the market, $30 is practically a given.
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Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI(R) in Multiple Sclerosis
Thursday November 17, 4:44 pm ET
CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 17, 2005--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA).
The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On September 26, 2005, the companies announced they had submitted the sBLA for the market re-entry of TYSABRI for MS and requested Priority Review.
The sBLA for TYSABRI in MS includes:- final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS;
- integrated safety assessment of patients treated with TYSABRI in clinical trials; and
- revised label and risk management plan.
"We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS."
"We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We will continue to work closely with the FDA as they review the filing so that TYSABRI can be made available with an appropriate benefit-risk profile." On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan recently completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.Last edited by jiesen; 11-17-2005, 06:12 PM. Reason: oops- didn't see that King already posted this- oh well, I'm leaving it up anyway, being such good news and all...
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Congrats on the good news dudes! I agree with jiesen though....the AH action was rather tame imo.
But I'm a bull! On the daily you've got a bull flag and probably a gap up tomorrow. Would be nice to see a huge volume day that will become a runaway for yall. I'd be looking for a nice bullish run to 11.50 that will make a 5th on the daily, then the abc and the c to maybe test the gap. 16.50 is very very likely after that. The really clever and patient people will buy the c long in a couple weeks. Hopefully that will coincide with a channel long and intraday pattern so I can hop on.
Where are my shades!
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MORGAN STANLEY EQUITY RESEARCH
ELAN CORP. (ELN.N): TYSABRI GETS PRIORITY REVIEW - 17 Nov 2005 (12 pgs/ 68 kb)
Marc Goodman +1 (1)212 761 8403 Morgan Stanley & Co. Incorporated
Louise Chen +1 (1)212 761 0039 Morgan Stanley & Co. Incorporated
Michael Rockefeller +1 (1)212 761 6184 Morgan Stanley & Co. Incorporated
Quick Comment: ELN and BIIB announced after the market closed that the FDA has granted priority review status to the Tysabri sBLA for Multiple Sclerosis.
Our Takeaway: This is obviously positive news for ELN (and BIIB), and we believe is the main reason for the recent strength in the name. With the priority review, the two companies will remain on track to launch the drug by mid 2006 in the US, as a decision by the FDA is now expected in late March 2006.
The criterion for a priority review designation is unmet medical needs (e.g., underserved refractory MS patients). Thus we do not think that Tysabri’s priority review status means greater probability of an approval. With that said, we continue to believe that the drug has a very good chance of returning to the market. In addition, the designation might signal a certain favorable attitude towards the drug within the agency. Thus some may believe that the final Tysabri label might not be as bad as previously feared. However, we still believe the label will be restrictive.
With the stock trading above $10, we believe that the Tysabri peak sales embedded at this level are $650-700MM. If investors want to own the name now, they need to have conviction that Tysabri can be a $750MM+ drug, in our view. We continue to believe that Tysabri will not likely achieve peak sales significantly above $500MM. We won’t know until next summer.
Industry View: We maintain our In-Line view of the Specialty Pharma Industry.
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Sent: Friday, October 21, 2005 2:20 PM
To: Matthew Strobeck; Will Muggia
Subject: Elan/Biogen Observation
Dear Investors:
Though we are not as exposed to Elan/Biogen as we were in the past, we feel compelled to provide a quick update on Biogen Idec and Elan given two articles published yesterday in the New England Journal of Medicine. In July, three different case study articles were published in the New England Journal of Medicine on the patients (2- Multiple Sclerosis and 1- Crohn's) presumed to have succumbed to Tysabri induced Progressive Multifocal Leukoenchephalopathy (PML). Please recall that one of the Multiple Sclerosis (MS) patients (from Colorado) reportedly died from the PML infection. In response to these articles, four neurologists drafted letters to the authors and the resulting correspondence was published yesterday in the New England Journal of Medicine.
Interestingly, all four neurologists noted that the Multiple Sclerosis patient who died from PML, likely did not have Multiple Sclerosis. These neurologists state that after reviewing the Colorado patients history, medical records etc.. that this patient did not have MS because: 1) no oligoclonal bands were detected in two separate examinations of the cerebrospinal fluid, 2) several Magnetic Resonance Imaging (MRI) scans obtained over many years never showed enhancing lesions and 3) neuropathology unequivocally proves that no MS lesions were ever detected (the presence of these lesions are the key hallmark of the disease). Based on this, the neurologists believe that this patient from Colorado may have had a subclinical nonfatal case of PML, which was misdiagnosed as MS. Strikingly, one of the original authors of the New England Journal of Medicine case study articles concurs with the potential misdiagnosis. Thus, this patient, likely should have never been enrolled in the MS study evaluating the use of Tysabri along with Avonex. These findings also bring into question the diagnosis/underlying condition of the other patients presumed to have developed PML due to treatment with Tysabri.
The suspension of Tysabri on February 28 was a prudent measure by both Biogen Idec and Elan to fully assess the situation and define the risk of PML to MS patients. However, these recent findings show the inherent variability/occasional errors that occur in the diagnosis and treatment of patients. If Biogen Idec and Elan can prove that this patient was misdiagnosed (which may be highly unlikely at this point) it could significantly change the risk profile of Tysabri. In the analysis we forwarded in early March, we cited the potential for misdiagnoses based on the strong safety data seen at two years in the monotherapy study and the known MS-like effects of PML in the brain.
It is astonishing how the public markets can jump to conclusions and formulate opinions, which at times are just not based on hard evidence. It does not matter now since the damage has been done, but we remain hopeful that Tysabri becomes available to the patients who desperately need it and that over time these issues around PML are resolved. We fully understand that being intellectually right; yet losing money is a bad outcome. However, our investment process has not and will not change.
Thanks again for your support.
Best,
Will Muggia and Matt Strobeck
William A. Muggia
President & Chief Investment Officer
Westfield Capital Management Company, LLC
One Financial Center, 24thFloor
Boston, MA 02111"
*************HUGE NEWS ******** these guys owned 42 million shares of elan before the stock fell>>>>>>>>>>
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