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that is unless Biogen/Elan decide to settle this out of court which is likely.

If they were smart, they would try.

Still, they won't be able to settle criminal charges completely out of court (which I still think are yet to come, but that's just my personal opinion).

Deb

From NCB -Orla Hartford

BiogenIdec Continue to Remain Positive

• Several positives can be taken from BiogenIdec’s Q2 results conference call last night. Firstly, management continue to remain positive on the return of Tysabri to the market.
The safety review is reported to be on-track and is expected to be completed at the end of the summer (21st September 2005) at the latest and will be followed by regulatory discussions on how to bring Tysabri back to the market (e.g. risk management program, revised label etc). During the quarter BiogenIdec recorded a $20m charge to cover the cost of Tysabri production and the development cost of a high-titre production
process for Tysabri.

• Secondly, BiogenIdec and Elan are currently taking steps to resume dosing of patients who had been on Tysabri in MS clinical trials and to begin clinical trials. It is BiogenIdec’s view that these trials are not required for the re-commercialisation of Tysabri.
In Phase II studies as patients withdrew from Tysabri treatment relapses recurred (after 6 months) although there was no rebound above the level seen in placebo patients. The FDA will therefore be conscious that the MS patients in trials before Tysabri’s suspension may be at risk of relapsing after a 6-month period without Tysabri.
Resumption of Tysabri for patients who were in clinical trials may therefore be possible by late August 2005. The re-opening of Tysabri’s IND and the subsequent restart to clinical studies was noted as an easier process than the comprehensive analysis required to bring Tysabri back to the market.

• Overall we see it as positive that BiogenIdec continue to talk confidently about Tysabri’s return. We continue to believe that Tysabri as a monotherapy will be relaunched as a treatment option for MS patients.


Orla Hartford Ph.D +353 1 611 5844 orla.hartford@ncb.ie

It doesn't surprise me that almost every press release about the possible re-introduction of Tysabri comes from the investor world and this article by Orla Hartford is no exception. I suppose I can't fault the investors because they and their clients have lost millions of dollars so far with Biogen-IDEC/Elan stock and they have to try and recover some of these losses.

I sure wish that they would wait until the medical research findings are complete but we all know that isn't how the "system" works!

Harry

....In Phase II studies as patients withdrew from Tysabri treatment relapses recurred (after 6 months) although there was no rebound above the level seen in placebo patients. The FDA will therefore be conscious that the MS patients in trials before Tysabri’s suspension may be at risk of relapsing after a 6-month period without Tysabri. ....

Read that statement closely, Harry.

There is no "rebound", but there is probable "relapse". *drumroll*..........And the difference is??????



Deb

Ok..........here we go:

Rebound:

a return to a previous state or condition following removal of a stimulus or cessation of treatment


Relapse:

a recurrence of symptoms of a disease after a period of improvement


Yeah, big difference.

Actually, if Biogen were smart, they'd tell everybody that it's a good thing there IS a rebound/relapse once Tysabri is removed from your system. Otherwise, if you were to come down with something like PML or some other infection while on Tysabri, stopping Tysabri wouldn't provide quick enough return to your previous state, thereby giving a patient NO chance of recovering from the infection.

I say "Thank goodness there IS a 'rebound' effect once you stop taking Tysabri"!



Deb

Deb, excellent analysis... I think what they mean (but that they are not being precise with) is that there is no GREATER relapse rate versus placebo on withdrawl of Tysabri. In other words, taking Tysabri away does not cause someone's MS course to become more aggressive in the form of more relapses than a patient that had not received it. But that's conjecture as I don't have the numbers in front of me to verify that.

Deb,

There is no "rebound", but there is probable "relapse". *drumroll*..........And the difference is??????

You know, when I read that article yesterday (a number of times) I thought that maybe I was missing something!! Glad you replied in the manner you did because I now know I didn't miss a thing!!

No relapse difference between those who withdrew from the Phase II trials and those on placebo but the FDA is concerned that those who can't get the Tysabri for 6 months are in danger of a relapse!!!! It's no wonder that MS patients get confused when listening to the "experts"!

Harry

9 August 2005

Biogen Idec and Elan Announce TYSABRI(R) Safety Evaluation Update

CAMBRIDGE, Mass. and DUBLIN, Ireland, Aug 09, 2005

-- Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that findings from their safety evaluation of TYSABRI(R) (natalizumab) in patients with multiple sclerosis (MS) resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML).

The companies have previously reported three confirmed cases of PML, two of which were fatal. The ongoing safety evaluation in Crohn's disease and rheumatoid arthritis is on track to be completed by the end of the summer. The companies anticipate making submissions to regulatory authorities in early fall of 2005. The companies are taking preliminary steps to restart clinical trials in MS.

More than 2,000 MS patients from clinical trials were eligible for the safety evaluation. To date, 91% of these MS patients participated in the safety evaluation. The remaining 9% of patients did not participate in the safety review. A total of 99% of patients participating in the evaluation visited their treating physician and had a neurological exam. In addition, 98% of participants had an MRI exam. The safety evaluation also included the review of any reports of potential PML in patients receiving TYSABRI in the commercial setting.

"Our ongoing TYSABRI safety evaluation is a rigorous medical and scientific undertaking that has been led by some of the world's leading experts in neurology and neuroradiology," said Whaijen Soo, MD, PhD, senior vice president, Medical Research, Biogen Idec. "Given the high unmet medical need in MS and the therapeutic benefit we have seen with TYSABRI, we are encouraged by these safety findings."

"The findings announced today are an important milestone in understanding the appropriate benefit-risk profile for TYSABRI. Patient safety remains our top priority. We are committed to finalizing the safety evaluation for Crohn's disease and rheumatoid arthritis, which is progressing well and on track to be completed by the end of the summer. We look forward to working with regulatory authorities to determine the path forward for TYSABRI," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan.

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 PML, a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for TYSABRI.

Biogen Idec and Elan will host a webcast for the media and investment community at 8:30 a.m. EST today to discuss the TYSABRI safety evaluation update. This webcast can be accessed through the investor relations' sections of the companies' websites.


http://www.elan.com/news/full.asp?ID=740984
.

Same story but from the business angle:


<shortened url>

Bromley

Bromley,

bromley wrote:Same story but from the business angle:

Always has been and will continue to be all about the money! There are millions and millions of dollars at issue with Tysabri and the sooner that Biogen/Elan get the drug back into the market, the better for their companies...especially Elan who needs the drug back in order to survive.

Harry

.
From NCB


In our view, the most important information disclosed yesterday from the safety review was the confirmation that no PML cases have been found in MS patients treated with Tysabri as a monotherapy. The absence of PML cases in patients on Tysabri monotherapy is an important finding and supports, we believe, the return of Tysabri to the market as a stand-alone treatment. We see little reason for the FDA to withhold the monotherapy treatment from MS patients given Tysabri's efficacy and safety along with the absence of PML cases in patients treated with Tysabri alone. The safety profile of the monotherapy is in contrast to that seen with the combination treatment where two cases of PML were detected in MS patients treated with Tysabri in combination with AVONEX.

• Following the completion of the safety review (this will include the safety data from the Crohn's disease and rheumatoid arthritis trials as well as the data from MS) a further update is expected over the next month or so. By early autumn, the entire safety data will be submitted to the FDA along with the proposed label changes and the 2-year clinical data from the MS monotherapy and combination studies. BiogenIdec expect an advisory panel meeting but this has yet to be confirmed by the FDA.

• BiogenIdec and Elan are not expecting any major changes to Tysabri’s initial label apart from highlighting the risk of PML. In addition, they continue to expect Tysabri to be indicated for relapsing/remitting MS and therefore do not anticipate use to be limited to a particular patient group or to second or third line use. Our forecasts assume use in patients that have fallen off existing therapies and patient switching from other treatments.

• We continue to believe that Tysabri as a monotherapy will be re-launched as a treatment option for MS patients. We are assuming a re-launch in 2006. The key catalyst from here is a positive outcome to the upcoming discussions with the FDA with Tysabri returning to the market.
.

I find another press release posted by Melody in this section rather interesting and I quote...

"Despite Mullen's optimism, there is still room for doubt on Tysabri. On a conference call with analysts at Sanford C. Bernstein last week, Daniel Wynn, a multiple sclerosis investigator, said that most patients being evaluated for safety were not given spinal taps--the most conclusive test for PML and the virus that causes it. Based on today's conference call with the companies, Wynn appears to have been correct.

"I think they are being very cautious on their language," says Geoffrey Porges, the biotech analyst at Bernstein. "The companies have said that there are no new confirmed cases, not no new potential cases."


I have no idea how many Tysabri patients had spinal taps done to check for PML. According to Dr. Wynn, most did not which makes me wonder just how accurate Biogen's evaluation may be. Every time they come out with some kind of announcement on Tysabri, the "experts" follow with more questions. And as usual, the MS patient is caught in the middle trying to determine what to believe.

Harry

Keep in mind Harry that Dr. Wynn has accepted monetary compensation from Serono for the promotion of Rebif.

http://my.webmd.com/content/chat_transc ... 102562.htm

http://www1.nmss.org/AZA/event/event_detail.asp?e=10673

Therefore, his questioning as to why only a percentage of patients were given a lumbar puncture (i.e. spinal tap) must be taken with heaping mounds of salt. It is journalistic malpractice to ignore the potential bias of a commentator, but this tends to be the norm rather than the exception unfortunately.

A lumbar puncture is not a day in the park. All of the patients who were in the trials received a full check-up from a neurologist and an MRI. If the patient felt fine, the MRI was clean, and the check-up went well, one would expect that most patients would decline the lumbar puncture since PML symptoms are rather obvious. This is exactly what happened, as only a percentage of patients went ahead with the lumbar puncture and all turned out to be negative for the JC virus.

The other "expert" in the article is Steve Porges, a Wall Street stock analyst. For the life of me, I do not know why you would view Steve Porges as an expert on PML. He is no more of an expert on PML than the average general practitioner.

So, no expert of any caliber is casting real doubts on the report. It is surely possible, albeit unlikely, that PML could be found in the RA and CD patients, or in one of the 5000 commercial MS patients. But this report is positive and straightforward on what has occurred with the MS safety review for trial participants.

Metsfan,

MetsFan wrote:Keep in mind Harry that Dr. Wynn has accepted monetary compensation from Serono for the promotion of Rebif.

I realize that but most quoted "experts" in the MS drug world have an affiliation with someone. That's how these companies compete with one another as they try to capture as much market share in that lucrative drug world.

Spinal taps are indeed tricky procedures but very accurate in determining PML. And they are costly so you aren't going to get everyone doing them. This dilemma adds another kink into the possible return of Tysabri because if it does come back, the docs will have to monitor their patients very closely for PML. And monitoring it properly is going to cost a lot and I wonder if the patient is going to have to pay for that.

The other "expert" in the article is Steve Porges, a Wall Street stock analyst. For the life of me, I do not know why you would view Steve Porges as an expert on PML. He is no more of an expert on PML than the average general practitioner.

I don't view Porges as an expert on PML. His quote reflected a financial person's point of view and it's that group of people who seem to be doing all the talking (with the help of Biogen) in these press releases. The financial world doesn't pay much attention to patients' health....they are only interested in the stock price!

So, no expert of any caliber is casting real doubts on the report

But every time Biogen comes up with an info release of some kind, you know that the financial world and competitors are going to comment on it immediately. And this latest release is no exception. It's too bad that Biogen would just remain silent until the FDA has a chance to review the data when given to them but we know that isn't their style. These mini press releases are going to continue as long as Biogen can give some kind of positive twist to Tysabri. It's called marketing and they are very good at it.

Harry

As a note if interest, my wife Marg had a check-up at the MS Clinic here in London, ON. At the end of the visit you just knew I had to ask the neuro about Tysabri's future.

He said that if it came back it would likely be quite some time (several months) before it would be allowed. He went on to say that he hoped it would return because he mentioned "further info" they had learned about the drug being good at slowing down the disease in certain patients. I asked him to elaborate and he stated that it would likely be good for those new, mild case MS patients who had an "inflammatory category" of the disease. For any other form of MS, it would be of no use at all.

He then went on to say that there would have to be a lot of caution using Tysabri because of its effect on the immune system and the patient could possibly be at risk to other kinds of infection.

The good news for Marg was that although she had SPMS and had broken her leg over 4 years ago, she was bucking the trend of what happens to most MS patients in this instance. He said that people in her situation generally declined at a steady pace and rarely improved. He felt that Marg had plateaued and was showing some signs of actually getting better. I guess Prokarin is indeed working for her!

Harry