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   Biotech / MedicalBiogen


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To: tuck who wrote (1658)1/22/2010 4:21:06 PM
From: mopgcw
   of 1685
 
i saw they announced a few more cases.

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From: mopgcw3/8/2010 11:47:56 AM
   of 1685
 
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 1685
 
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 1685
 
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 1685
 
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 1685
 
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 1685
 
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 1685
 
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 1685
 
>>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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From: mopgcw12/18/2010 11:35:01 AM
   of 1685
 
cs: Biogen Idec (BIIB) NEUTRAL [V] Industry Weighting: OVERWEIGHT R. Mehrotra
CP: US$ 67 TP: US$ 68 CAP: 16b

INITIATING Coverage with a NEUTRAL Rating and Target Price of $68 - Facing Negative Competitive Pressure Now; Potential
Upside Triggers Post 2013

! Summary: We are initiating coverage of Biogen (BIIB) with a Neutral rating and a $68 target price. The changing dynamics
of the MS market places significant medium-long term risk on BIIB's core revenue franchise that is likely to cap
fundamentally driven stock price performance. Significant pipeline readouts are unlikely to occur until 2013. However, BIIB
could benefit from our agency cost reduction hypothesis an/or further cost containment.

! Current Product Offering: Over 70% of total revenues come from its lead multiple sclerosis (MS) products Avonex and
Tysabri. We model moderately declining revenues long-term due to competition from oral agents, especially NVS Gilenya -
which launched in October.

! Pipeline: The near-term pipeline is focused on MS. We are cautious on commercial potential of BG12 (PIII), Pegylated
Avonex (PIII) and Ocrelizumab (PII). Longer term, we are excited about the hemophilia program. However, Phase III trial
readouts do not occur until 2013 so the market will likely discount this for at least the next 12 months.

! Where Do We Most Differ From the Street? We model greater declines in Avonex revenues. We model flat Tysabri growth
vs. reacceleration due to PML assay. We assume greater operating and earnings leverage than consensus; for 2015, we
are 18% and 1% lower on revenues and earnings respectively.

! Agency cost analysis/Valuation: BIIB could start a 4% dividend and accumulate $4B cash by 2015. We model BIIB 2010-15
top-line and EPS CAGR of -1% and +7% (versus +1% and +4% for the peer group). Our $68 target price is based on a
10% PE premium with peer group. PharmaValues estimates $68/share NPV. Contact your CS sales representative for a
detailed slide deck.

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