Biogen Idec, Elan Suspend Use of Tysabri

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby OddDuck » Thu Mar 03, 2005 11:05 am

From what I can tell, Harry.........."insider trading" is about to be the "key word" in all this.

But, we'll have to wait and see for certain what the government does.

Deb

EDIT: Here is just one example:

http://www.startribune.com/stories/535/5268033.html

MS drug withdrawal prompts 2nd look at Biogen Idec stock sales
Mark Jewell, Associated Press
March 2, 2005

BOSTON -- The withdrawal of a new multiple sclerosis drug has focused scrutiny on millions of dollars in insider stock sales at Biogen Idec Inc. and executive bonuses awarded before the company disclosed a death and illness that led to the drug's removal from the market.

The stock transactions -- one of them on the same day the company notified federal regulators about the problems -- came before Monday's withdrawal of Tysabri wiped out a total $17.8 billion in shareholder equity in a single day for Biogen and Elan Corp. The biotechnology partners had enjoyed surging share prices during the past year on high expectations for their jointly developed drug.

Within a four-day span before the drug's makers notified the Food and Drug Administration of the problem, three Biogen executives sold stock.

That notification occurred Feb. 18 -- the same day Thomas Bucknum, a Biogen executive vice president and the company's general counsel, sold 89,700 shares for a profit of $1.9 million, according to the company's filings with the Securities and Exchange Commission. Bucknum's gain reflected the rise in the value of company shares since the options were granted starting in 1998.

Bucknum also was awarded new options of 55,000 shares on Feb. 17, the day the company's board approved a committee recommendation granting Biogen executives cash bonuses totaling $4.6 million based on its performance last year.

Biogen's executive chairman, William Rastetter, sold more than 120,000 shares on Feb. 15, yielding a $7.45 million profit, the filings show. The day before that, Biogen director Robert Pangia sold 15,570 shares for a profit of $954,844.

Walter Ricciardi, head of the SEC's Boston office, declined to comment Tuesday, citing agency policy not to discuss what his office may or may not investigate.

Biogen spokesman Jose Juves said the stock transactions were planned before the company learned of Tysabri's problems and notified the FDA.

"All these trades preceded that quick and decisive action, which was guided exclusively by concern for patient safety and our commitment to the MS community," Juves said.

"No one waited around to inform the FDA, and the trading window was immediately shut as soon as the senior management became aware of the safety issue," Juves said.

After the company notified the FDA, one patient died from a rare and frequently fatal disease of the central nervous system. Another, with a suspected case of the same illness, survived. Monday's withdrawal of Tysabri and suspension of clinical tests came 10 days after the companies notified the FDA.

Biogen shares lost more than 42 percent of their value Monday, while Elan's stock fell 70 percent.

On Tuesday, Biogen shares rose $2.61, or 6.8 percent, to close at $41.26. Elan shares closed down 3 cents at $7.97.

Regardless of Biogen's statement that executives were unaware of Tysabri's problems before their recent stock transactions, W. Michael Hoffman, executive director of the Center for Business Ethics at Bentley College in Waltham, said he found it "suspiciously coincidental that they would be selling these shares almost on the eve of this occurring with the FDA."

Corporate America faces increased scrutiny of insider stock sales in advance of bad news because of revelations at companies such as Enron. Some executives at the energy trader were accused of dumping stock days before Enron went bankrupt.

Such sales "have not only been considered illegal in terms of insider trading but are not building up the trust in the corporations the executives are overseeing," Hoffman said.

Until Monday, Biogen's portfolio of cancer and autoimmune-disease treatments made the company one of the top-performing biotechnology stocks in the past decade.

Biogen and Elan continue to hold out hope that Tysabri eventually may return to the market if it can be proven safe.

The drug, which won FDA approval in late November, accounted for $3 million in sales for Biogen in the final weeks of 2004. Tysabri had been forecast to reach $1.5 billion in annual sales by 2007 and continue growing in coming years.

Now, Cambridge, Mass.-based Biogen and Ireland-based Elan are left to rely on other medications in their portfolios. Biogen's Avonex is a nine-year-old MS treatment that accounted for nearly two-thirds of the $2.2 billion in revenue last year at the world's third-largest biotech company.

While Avonex most likely will pick up some of the sales lost from Tysabri's withdrawal, the newer drug "was Biogen's growth engine," said Jason Kantor, an analyst with WR Hambrecht & Co. "Now, the prospects for it are zero until we hear otherwise."
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Postby HarryZ » Thu Mar 03, 2005 12:18 pm

OddDuck,

I didn't think it would be too long before the SEC started to look at those stock transactions. Like I'm sure many people are thinking, the coincidence and timing of this is simply too suspect to go uninvestigated.

I'm sure by the time everything comes out in this entire ordeal, Biogen is going to go under the microscope from several agencies, something a huge corporation doesn't really welcome!

Harry
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Postby flora68 » Thu Mar 03, 2005 12:22 pm

coolycat, if you're still around...

I know a lot of other people feel the same way you do about Tysabri looking so promising, and then being taken away as suddenly as it was released. Angry, frustrated, despondent, suspicious, in denial, whatever; there are a lot of bad feelings. Regardless, they're your feelings and you're entitled to them.

But you're venting them in the wrong direction, kid. Harry didn't do anything to anybody, nor did Deb. They just figured it out before you did, that's all :( .

However, you are right about one thing :D ; most people in the trials did report significant improvement on Tysabri, as did many who started on it after FDA approval. No doubt about that part. And it's also true that "only" 2 people in the trials died from it so far, out of almost 3,000.

And to someone who obviously knows (and cares) little or nothing about things like scientific method, drug trial protocols, the immune system, and the many other decidedly un-sexy facts and details of this situation like JCV and PML, those figures may sound like acceptable odds. Sounds like "only" 2 people died, out of almost 3,000 "helped", right?

Wrong.

Because they weren't finished yet! (Speaking of which, why, precisely, do you "find it unlikely" that there would have been any more deaths if they hadn't suspended use of Tysabri?)

You can't tell how further Tysabri use would have worked out any more than you can tell by the number of characters alive at Intermission how many will still be on their feet by the end of the last act.

More importantly, no medication can be considered a success if the patients start dying off after only two years of trials.....

There's no reason to assume that the improvement seen with Tysabri would or wouldn't have continued indefinitely, particularly without harm to the patient. I can tell you that leaving one's brain totally defenseless against things like meningitis or encephalitis isn't going to remain anyone's answer for long. :roll:

No, coolycat, people with immune systems don't just up and die from the JCVirus.

And there are important reasons why drug trials are supposed to last longer than Tsaybri's did before unleashing it upon the masses, no matter how impatient people are to cut to the punch line.

A bit of advice: If you're really hoping to hold your own in this particular "discussion" with two MS-research heavyweights like Harry and Deb as opponents, do yourself a favor and actually do some reading first. The last article pasted would be a good place to start.
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Postby OddDuck » Thu Mar 03, 2005 1:17 pm

Thank you for your support, flora.

And I DO sincerely want to express again (in case it was missed), when I first learned of this, my first response was on behalf of the sufferers with MS. I have been literally sick over it, not to mention I can hardly bear to think of any lost lives.

Again, I say............I am SO sorry. Harry and my initial reasons for ever expressing ourselves so adamantly to begin with was not to try to "get" Biogen/Idec or Elan, it was truly simply because of our great concern for the safety of patients.

Again, all I can think of to say is how sorry I am. Right now, forgive me, but I'm truly at a loss for words to try to make anyone feel better.

As I told bromley the other day and another person today (in the General Discussion section), don't give up. Tysabri wasn't and isn't the last hope for MS treatment.

It's a setback, but I'm certain only a temporary one.

As for the deeds or "misdeeds" connected with this whole fiasco, that is a separate issue. And flora, if you don't mind me sort of borrowing something from you that you said similarly one time, this particular thread is becoming more focused mainly on those actions (politically, legally, duty of trust, etc.), so reader beware.

Deb
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Postby JoanCT » Thu Mar 03, 2005 2:44 pm

I have been watching these stock sales reports over the last few days. If you haven't already, go back and read Harry's recap of the two patients - horrifying for a number of reasons. Then consider how likely it is that these executives, who reportedly sold a combined 10 million dollars worth of stock in the DAYS before this news broke, were not aware of the condition of two patients - still in the trials - who received their last infusions in early December. No January infusion, no February infusion.

From the bostonherald.com:
The Securities and Exchange Commission is preparing to interview executives who made $10.7 million on stock sales before the company yanked its high-flying new multiple sclerosis drug.

Both Biogen and the SEC yesterday refused to comment.

and
Whatever the outcome of the investigation, Monday's news ended a golden period on the stock market for Biogen. The stock, just $35 a year ago, soared above $60 last spring on high hopes and largely stayed there till now.

An analysis by the Herald shows that during that time directors and executives made $32 million - perfectly legally - cashing in their share options.


Seems to me that if you had that much skin in the game you might be keeping tabs on how the patients were doing. This only makes the entire thing more nauseating. Joan
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Postby OddDuck » Thu Mar 03, 2005 2:55 pm

Joan,

I'm totally with you. And remember, I noticed them moving around stock, etc. BEFORE Tysabri hit the market at all, and I mentioned it. And who am I, ya know? If I noticed it back then, well...................

I just think that a lot of people will have much more to answer for than the few questions and outrage that many of us in the public have.

Deb
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Postby coolycat » Thu Mar 03, 2005 6:10 pm

OddDuck wrote:
We see deaths in trials all the time. I don't believe that Biogen knew of these pml dx's & death prior to the release.


That's funny. How and why is it then, that Harry knew about it WAY before the release from Biogen. If Harry knew, believe me, I can't help but "suspect" that Biogen knew. (Forgive me, but the accusations and chances of Harry just making that up out of thin air or spreading "rumors" doesn't cut it anymore, does it?) And besides, it's not just "us" on this website asking about it. It's the SEC. You might want to consider voicing that opinion and your support to the SEC, then, and help Biogen Idec/Elan that way.

I will most likely use Tysabri as my MS treatment when and if it becomes available again.


Well, there's "one". (Sorry for the sarcasm.) But wait.......you said "most likely". For someone so positive about everything, is that "doubt" that you are expressing after all? And what if you don't meet the very probable new and narrowed down "criteria" for taking Tysabri when and/or if (as you yourself eloquently stated) it comes out again?

I've read far to many stories of people with astounding improvement while on Tysabri and even some from folks who were on A & T, are doing much better with no ill effects from the combo.


And as Harry and I (to mention just two) are always so respectfully "asked", is that statement simply based on rumor or from unknown "sources", or can written verifiable "proof" be provided?

Actually, there's no need to answer.

Deb


My, my, aren't we the fussy odd duck :roll:

Harry heard about it from Cherie Binns and Cherie Binns information was inacurate! She said that there were 3 deaths. I'm not sure how many, but she has stated over and over that some were caused from anaphalyactic shock. Where's the proof of that?

Also, there has been 1 death reported, not 3. One case of PML dx and one death from PML.

Don't get me wrong, I'm upset that anyone has died, one, three, ten..It doesn't matter, a death is a death! My heart goes out to this person's family. I'm not saying that it should be overlooked.

I know of at least two people personally who have improved with only 2 or 3 infusions. That's where I got my "proof" you're asking for. I've also read it on several MBs. Why would a poster, who is a long time member in good standing lie about something like that?

Yes I did say when and if Tysabri came back on the market, I would most likely use it. I have no idea what the future holds and I might not be a good candidate for it, hell, I might get hit by a bus tomorrow. Tysabri wouldn't do me a lot of good then, would it?

BTW, until I'm asked to leave this forum by the owner, I'll show my support for Tysabri here or anywhere else I choose, thank you very much.

[edited]
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Postby Arron » Thu Mar 03, 2005 6:34 pm

Diversity of opinions is critical here, so long as everyone keeps the tone friendly at best and professional at worst. We have enough problems to deal with given this Tysabri surprise...
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Rage Against the Machine

Postby DenverCO » Thu Mar 03, 2005 8:16 pm

The passionate anti-Biogen sentiment expressed by several members of this board makes me wonder what fuels such intense emotion. It feels very similar to the Bronco fans hatred of the Raiders. There is such a strong rivalry there that a Raider player can't even walk onto the field without the Bronco fans saying, "Look at him! He thinks he's so hot! The Raiders make me sick! The only reason they have the record they do because they cheat!"

I think Daunted hit the nail on the head when he/she posted in another thread, "There is a (natural) temptation to make Tysabri the effigy which we burn in collective frustration for the existance of multiple sclerosis."

Some of you have tied old Biogen to the proverbial whipping post, and the company has become the target for all of your anger. While mental health professionals would agree that it's good to get it out, you guys need to temper some of that rage with meditation or deep breathing. At the rate you're going, someone might develop a new lesion!
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Postby HarryZ » Thu Mar 03, 2005 8:28 pm

Cookcat,

Harry heard about it from Cherie Binns and Cherie Binns information was inacurate! She said that there were 3 deaths. I'm not sure how many, but she has stated over and over that some were caused from anaphalyactic shock. Where's the proof of that?


Cherie Binns was told weeks ago by a Serono rep that two patients in the trial had died. She called a Biogen rep that she knew and this info was confirmed to her by that rep. Now we hear of a third patient who died and another who is very ill with PML. Cherie is trying to find out just how many people died and the time frame. Until now Biogen has reported only one death. Their recent track record when it comes to the truth isn't exactly the kind of story I would include in ethics 101!!

BTW, until I'm asked to leave this forum by the owner, I'll show my support for Tysabri here or anywhere else I choose, thank you very much.


Nobody on this forum is EVER asked to leave because of their opinions, Coolcat. Everyone is entitled to his or her opinion. If you choose to support Tysabri, that's fine and is your right. But be prepared to answer questions and read opposing points of view to Tysabri and Biogen. There are a few of us who go a lot deeper into this drug and Biogen and don't like what we have seen.

Harry
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Re: Rage Against the Machine

Postby HarryZ » Thu Mar 03, 2005 8:55 pm

Denver,

Biogen is getting the brunt of the criticism because it deserves it! That's all you have to do is look at their actions from the way they rushed everything with Tysabri to their executives actions in the stock market. They failed to listen to the warnings of prominent MS docs and have now ended up in a real mess. They've prompted legal action against them because of what they have done and have caused unmeasurable grief for thousands of MS patients.

Should they be congratulated for all of this....I hardly think so!! And it's going to get a lot worse when the lawyers start digging.

Harry
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Postby OddDuck » Fri Mar 04, 2005 3:33 am

Number one: Coolycat. Personal attacks are not tolerated here. And that's that.

Number two: Denver. I don't like any company or person who has a criminal record and shady dealings. (Go read it yourself.) That's not an unfounded accusation by me. It's proof Biogen itself reports in their own SEC filings. (And apparently, neither do many other people. But then again, a person would have to "read" and research first.)

If YOU like criminal activity, great! But I don't. And I also would never want to be connected or seen nor heard supporting such people.

If you don't like my character, integrity, and insistence on honesty, that's your prerogative. But keep it to yourself. Doing anything less than that is called "defamation" and is actionable under the law.

AND, as Arron has already mildly warned you guys, don't start attacking us personally here on this particular forum. We've been there, done that, and we're still here and they aren't. This is NOT Yahoo or CafePharma.

People died, Biogen/Idec/Elan lied (correction: it is "suspect" that they did and/or have in the past), and it has been PROVEN that we were right. Don't even attempt to try to put a new twist to old conversations that have already taken place here, and which serve no purpose. That's my suggestion.

I'm not going to go head to head with you two (Denver and Coolycat). It's not worth my time. Have fun arguing with the wall, because it won't be me answering your posts after this.

I stand on my established credibility. Nice try, though.

I rest my case.

Deb
Last edited by OddDuck on Fri Mar 04, 2005 5:04 am, edited 2 times in total.
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Postby OddDuck » Fri Mar 04, 2005 4:08 am

By the way, speaking of the number of deaths so far, anyone "read" this?

Biogen Idec Inc. and Elan Announce Update on TYSABRI
2005 Mar 3 7:18 PM

Biogen Idec Inc. and Elan Corporation, plc announced an update on the voluntary suspension in the marketing of TYSABRI (natalizumab), a treatment for multiple sclerosis (MS). On February 28, 2005, the companies reported that they had suspended marketing of TYSABRI based on one confirmed case and one suspected case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system. The investigator has now changed the status of the second case from suspected to confirmed. The companies are continuing to examine these two cases. Both patients received more than two years of TYSABRI therapy in combination with AVONEX. To date, the companies have received no reports of PML in patients receiving TYSABRI monotherapy for MS or in patients with Crohn's disease or rheumatoid arthritis. Biogen Idec has not received any reports of PML in patients treated with AVONEX alone, a product on the market since 1996. Biogen Idec and Elan will work with clinical investigators to evaluate TYSABRI-treated patients and will consult with experts to better understand the possible risk of PML. Based on the full results of these evaluations, the companies, in consultation with regulatory authorities, will determine the appropriate next steps. In addition, Biogen Idec and Elan have undertaken to provide information to the Securities and Exchange Commission in connection with the voluntary suspension in the marketing of TYSABRI.


Just FYI.

Deb

EDIT: In other words, if the second case of PML is now "confirmed" and PML is fatal, then................
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Postby coolycat » Fri Mar 04, 2005 5:30 am

Odd Duck,
Could you tell me where it is that I launched a personal attack on you?

I came here, stated how I felt about Tysabri and I feel I was attacked by you, not the other way around.

Even though I don't always agree with Harry, at least he doesn't get his feathers ruffled by opposing views.

My goodness, we all have MS or in Harry's case, have a loved one with MS. It seems to me that we should all pull together, not fight against each other.

I'm also surprised that my post was edited. Weird.

I agree with Denver (I think that was his/her name) I don't understand where all this anger is coming from.

Apparently you didn't use Tysabri as your MS treatment, so what's up with your fury? It seems more plausible that people like me would be the ones who are upset. People who actually held hope for a brighter future. Not folks who doubted Tysabri to begin with.

Admittedly, the future doesn't look to bright for Tysabri. Apparently the second person with PML has died. :( Very Sad.
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Postby HarryZ » Fri Mar 04, 2005 6:27 am

Coolycat,

My, my, aren't we the fussy odd duck :roll:


That's the kind of comment that Arron was referring to as making a personal attack and has politely cautioned you. Those statements serve no purpose. Like I posted earlier, everyone is entitled to their opinions but that statement isn't an opinion.

While we all can become upset with other people's comments from time to time, it's best to keep the messages as objective as possible.

Harry
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