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   Biotech / MedicalBiogen


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To: mopgcw who wrote (1657)1/22/2010 4:08:11 PM
From: tuck
   of 1684
 
Biogen will alert Drs. on a password protected website regarding further cases of PML. Investors have to contact IR. Another system skewed towards firms with medical consultants. Mid month. I suspect IR is going to be very, very, busy then. Another thing one could monitor would be large put buys on Elan and Biogen at those times . . .

>>Biogen Revises Brain Infection Disclosure Policy For Tysabri
Last update: 1/22/2010 2:32:30 PM

By Thomas Gryta
Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech strives to find the right balance in keeping the medical and financial communities updated on that important number.
The situation is closely watched because Tysabri, a highly effective treatment sold with Elan Corp. (ELN), was previously pulled from the market because of its association with progressive multifocal leukoencephalopathy, or PML, a debilitating and often fatal condition. The infection rate has hurt the sales growth of the drug, which is key to Biogen's future and is Elan's biggest seller.
Since its re-emergence in 2008, Biogen and regulators have struggled with how to provide information on PML because case-by-case updates of a specific side effect are unprecedented. Last summer, the Cambridge, Mass., company stopped providing updates altogether.
As of mid-January, the number of cases stands at 31, which puts the overall incidence rate at about 1-in-1,000 patients, as implied by the drug's label.
Under the new plan, Biogen will proactively update physicians midmonth and provide information through a password-protected Web site. It will include the number of PML cases, with an incidence rate broken down by duration of use, as well as a cumulative patient exposure figure, which is different then the quarterly patient count provided to investors.
Investors can get the same information from investor relations, although the company won't be posting it on a public web site or making an announcement.
Patient services will provide Tysabri users with information upon request, although not with the level of detail given to physicians, or even to investors.
The reason for the disparity between how doctors and patients are updated is because of regulations that restrict direct interactions between patients and drug companies, because those communications could be deemed as promotional activities and thus need to be cleared with regulators.
Major developments would be communicated outside of the regular updates and regulators will continue to receive information on a realtime basis.
Biogen withdrew the drug from the market for 18 months beginning in 2005 after three patients developed PML. Infections re-emerged in 2008, and Biogen provided regular weekly updates to the public until last July, when it officially stopped providing any information.
In October, European and U.S. regulators said the number of PML cases had risen to 24, well above Biogen's July disclosure of 11, surprising Wall Street and raising questions about Biogen's disclosure policies and refusal to comment on PML case numbers. The company began to re-think its approach at about the same time.
"We just realized that that just wasn't going to work," said Biogen spokeswoman Naomi Aoki, who noted that information about new cases continued to become public through other sources despite the company's decision to not comment.
"It fueled a greater fear factor than being consistently transparent about the information," she said. "This [change] is driven by what the medical community needs and wants."
On Thursday, the European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, recommended increased risk-mitigation measures for Tysabri after reviewing its safety. The panel concluded that Tysabri's benefit for MS patients outweighs its risks and the drug should stay on the market.
Tysabri had more than $1 billion in 2009 sales, but its controversial history has provoked fear in investors and confusion about the disclosure of new cases hasn't helped.
Biogen's stock was up 12% in 2009 and Elan rose 9%, compared with a 23% rise in the S&P 500, and both stocks saw plenty of Tysabri-related volatility. This month, Biogen Chief Executive James Mullen said the share price has been "bound by uncertainty over Tysabri."<<

Cheers, Tuck

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To: tuck who wrote (1658)1/22/2010 4:21:06 PM
From: mopgcw
   of 1684
 
i saw they announced a few more cases.

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From: mopgcw3/8/2010 11:47:56 AM
   of 1684
 
WSJ: Roche, Biogen Suffer Setback With Experimental Drug
By GORAN MIJUK

ZURICH--Roche Holding AG and Biogen Idec Inc. said Monday they suspended a rheumatoid arthritis program using drug candidate ocrelizumab because of safety concerns, further cutting the experimental drug's market potential.

The suspension was recommended by the independent Data and Safety Monitoring Board, or DSMB, which found risks outweighed potential benefits after cases of serious infections led to several deaths. It follows earlier program halts in the ocrelizumab treatment of lupus and rheumatoid arthritis, two autoimmune diseases.

"The decision to put the trial on hold doesn't come as a surprise as earlier programs have already been stopped," said Birgit Kulhoff, analyst at private bank Rahn & Bodmer, who has the stock on its recommendation list. "Given the U.S. Food and Drug Administration's intense focus on safety, the chance that the product won't make it to market is very high now," she said.

Shares of Roche, which have gained around 51% over the past twelve months, showed little reaction to the news as investors were expecting another trial setback for ocrelizumab. They were down 0.6% at 179 Swiss francs ($166) in late morning trading.

"Patient safety is of the utmost importance in all of our drug development programs," said Roche's Chief Medical Officer Hal Barron. "In light of the DSMB recommendations we have decided to suspend ocrelizumab treatment in the rheumatoid arthritis clinical development program."

Ocrelizumab was expected to reach peak sales of between $1 billion to $2 billion in the three indications rheumatoid arthritis, lupus and multiple sclerosis. If approved, the drug could have helped Roche to manage the life-cycle of its cancer drug Mabthera, which loses its patent protection over the next five years, according to analysts.

Roche said it will first analyze the program data in question before deciding on the future of the biological drug in the treatment of rheumatoid arthritis. Ocrelizumab will be further studied in the treatment of relapsing-remitting multiple sclerosis, which is currently in Phase II trials, Roche said.

Although Roche will continue with its MS trial, Helvea analyst Karl-Heinz Koch said that based on the latest safety data, "the chances of the drug to continue its clinical path in the relapsing-remitting multiple sclerosis is increasingly unlikely."

Mr. Koch, who rates the stock at buy, expected peak sales of around 800 million Swiss francs. However, due to the increased likelihood that these trials could be halted too, he has removed the sales estimates from his model, cutting the company's share-price target to 191 francs from 195 francs.

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To: mopgcw who wrote (1660)3/8/2010 12:57:36 PM
From: scaram(o)uche
   of 1684
 
Thanks for that!

Does anyone have a clue to the "why?" part? That is, why would it be worse (or is it?) than rituxan?

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To: scaram(o)uche who wrote (1661)3/11/2010 1:48:28 PM
From: Pseudo Biologist
   of 1684
 
We can start with the what

As you may recall Rituxan is chimeric 2B8

Ocrelizumab is humanized 2H7

So, the CDRs are not 100% identical, though they are very close:

In the LC each of the 3 CDRs differs from 2H7 vs 2B8 by 1-2 amino acids. In the HC 2 of the 3 CDRs are identical and the third differs by a few amino acids.

For reasons that are not altogether clear, ocrelizumab has better ADCC and slightly worse CDC than Rituxan. (see for example ncbi.nlm.nih.gov where the ADCC item is stated; I have seen the actual data presented in conferences, but I am not sure this second if published more formally).

No need to tell you this, but I think without more detail on dosing and the like it is hard to say for sure that ocrelizumab is indeed worse (more toxic). Even assuming one could an apples to apples comparison of trials, it is hard to see why the ADCC/CDC observations alone would account for such a difference. Data on how patients with different Fc receptor polymorphisms do may shed some light on this.

Very tricky business this one of making so-called "bio betters."

PB

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To: Pseudo Biologist who wrote (1662)3/11/2010 1:56:24 PM
From: scaram(o)uche
   of 1684
 
Very tricky business this one of making so-called "bio betters."

Years and years of THE expert commentary. Thank you for all that you've done for us, lots and lots of us. Can't think of anyone who I respect more highly.

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To: scaram(o)uche who wrote (1663)3/11/2010 7:19:23 PM
From: Pseudo Biologist
   of 1684
 
Sure, thanks, now I am blushing. But, can my rambling help anyone make any money? ;->

PB

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To: Pseudo Biologist who wrote (1664)3/11/2010 7:49:53 PM
From: scaram(o)uche
   of 1684
 
Sure, yes. If they're into protein constructs and digging for leveraged investments, the sophisticated investor knows you. In the old days, I turned lots of your stuff into gold. Now I'm lazy.

:-)

Yes, definitely.

But biological roulette is hard, sometimes it's going to beat every brain around.

:-)

Best! Rick

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From: sim13/25/2010 6:20:37 AM
   of 1684
 
Biogen Idec and Elan Enroll First Patient in Large, Well-Controlled Head-to-Head Study of Multiple Sclerosis Treatments

– Study Aims to Inform Treatment Decisions and Improve Patient Outcomes by Directly Comparing TYSABRI to Copaxone and Rebif –

Message 26411881

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To: sim1 who wrote (1666)8/19/2010 4:14:17 PM
From: tuck
   of 1684
 
>>Brain Infections From Biogen, Elan MS Drug Continue To Rise
Last update: 8/19/2010 4:08:27 PM

By Thomas Gryta
Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--The incidence of a rare brain infection in patients taking multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. (ELN), is continuing to climb, raising concerns about the drug's future.
The drug is considered highly effective and is important to the future of both companies, but its growth has been disappointing because of its link to progressive multifocal leukoencephalopathy, or PML, that led to temporary market withdrawal in 2005.
Data from clinical trials of the drug suggest that PML occurs in one in 1,000 patients, a rate that has been included on its label.
The overall PML rate remains below that level, but it continues to creep higher and numerous measures that correlate with the amount of time spent on the drug show that the rate is exceeded. On Wednesday, the company disclosed five more PML cases, bringing the total to 63 since its relaunch in 2006.
The U.S. Food and Drug Administration monitors PML infections and assesses the related risk "on an ongoing basis to determine the need for any regulatory actions," spokeswoman Sandy Walsh said. The agency will consider label updates and/or additional safety updates as it reviews cases and identifies other relevant information.
"What is in the drug's label now reflects what we know about the incidence data--it would be too speculative to make conclusions about the trends right now," Walsh said Thursday.
Biogen spokeswoman Kate Weiss said the company is constantly in discussions with regulators, but declined to comment further on those talks. She noted that the company is aware of the rising incidence trend.
"Obviously it is something that we are looking into," she said.
PML is caused when the JC virus attacks the central nervous system in people with weakened immune systems, often leading to an irreversible decline in neurologic function and, in some cases, death.
The overall incidence data, including all patients that have used the drug, has been steadily rising and now shows that PML occurs in 0.85 per 1,000 Tysabri patients, as of Aug. 4, a number that stood at 0.47 as of a January update.
For patients using the drug more than a year, the rate now stands at 1.35 per 1,000. But the confidence interval, a statistical tool that helps show the precision of a measurement, shows that there is a 95% probability that the risk is between 1.04 and 1.73 per 1,000 patients. A similar situation--the lower end of the confidence interval being above 1--also occurs in those on the drug longer than 18 months and 24 months, strongly suggesting that the rate is above 1 in 1,000 in those measurements.
The increased risk of the infection with longer use of the drug is included in the drug's label, but Barclay analyst Jim Birchenough warns that the rising case numbers could create "still greater tentativeness in prescribing." Furthermore, it could increase the use of so-called drug holidays--when patients are temporary removed from the drug with the intention of reducing risk--and it could encourage those holidays to come earlier in treatment.
For patients getting 30 months of therapy or more, the incidence of the infection is 1.4 per 1,000 patients, a drop when compared with earlier duration measurements. This drop is even larger for those on the drug longer than 36 months.
But Biogen views the drop as inconclusive, because there aren't enough patients to have confidence in determining that the finding is real.
"We need to see more patient data," she said.
Barclays's Birchenough echoed the sentiment that the data beyond 24 months of therapy is "relatively small."
There is no way to determine what the data from the longer durations will eventually show, but the incidence at earlier durations was once well below the levels now seen in the longer durations, suggesting that they could catch up. They could also show that risk peaks at a certain point in using the drug.
Analysts are concerned about the trends because Tysabri is being sold in a increasingly competitive MS-treatment market and its side-effect profile could make alternatives more attractive.
There is concern that Tysabri use will decline if Novartis AG (NVS, NOVN.VX) gets approval for Gilenia, the first oral MS treatment, which should get a decision from the FDA in September. Meanwhile, several other companies are developing oral therapies for the disease.
Deutsche Bank analyst Robyn Karnauskas recently projected that Tysabri's patient discontinuation rate, currently 2% to 3%, will skyrocket when oral therapies are available. She projects 20% of patients on the drug will stop using it in 2011 and 25% in 2012.
She also expects that fewer patients will begin using Tysabri, as the new options are available, and projects U.S. Tysabri sales declining 40% from $633 million in 2010 to $376 million in 2015.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com<<

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