| To: Pseudo Biologist who wrote (1664) | 3/11/2010 7:49:53 PM | | From: scaram(o)uche | | | | 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: sim1 | 3/25/2010 6:20:37 AM | | | | | | 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 | | | | >>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 $376 million in 2015.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com<< |
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| From: mopgcw | 12/18/2010 11:35:01 AM | | | | | | cs: Biogen Idec (BIIB) NEUTRAL [V] Industry Weighting: OVERWEIGHT R. Mehrotra
CP: US$ 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 $68/share NPV. Contact your CS sales representative for a
detailed slide deck. |
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| From: mopgcw | 4/9/2011 10:05:37 AM | | | | | | cs Biogen Idec (BIIB) NEUTRAL [V] R. Mehrotra
CP: US$ 73.03 TP: US$ 69 CAP: US$ 17.4b
BG12 - What are the real issues?
! DEFINING the potential of BG12: Biogen has guided to data from the DEFINE study (BG12 vs. placebo in RRMS) being
released in H1 2011. Following our recent deep dive into BG12's putative competitor Laquinimod (published 1st April), we
have conducted similar analysis on BG12. A detailed slide pack of our analysis is available upon request from your CS
sales representative. Top line conclusions:
! The conclusions that could be drawn from the headline DEFINE data release are likely to be limited due to differing primary
endpoint vs. other pivotal placebo-controlled studies. The endpoint of percentage of relapse-free patients differs from the
more commonly seen relapse-rate. Historically a % relapse free endpoint has been harder to achieve.
! BID vs. TID - We are cautious on the ability of BG-12 to hit significance at BID dosing. We think BID dosing needs to work
for BG-12 to be commercially viable as our talks with KOLs suggest few would prescribe the TID regimen to avoid low
compliance, reducing BG-12's "real-life" efficacy. Some scientific logic suggests its total dose drives efficacy.
! We get mixed opinions from physicians on tolerability in "real-life use". BG-12 is an oral dimethyl fumarate which has been
used for psoriasis in Germany since 1994 - physicians are used to the BG-12 side effects (flushing and GI). However, they
titrate the dose (both up and down) frequently with the average dose being 360-480mg. This raises questions about BG-12s
tolerability at high doses in the MS setting.
! We see the biggest wildcard upside for BG12 in combination use. As discussed in our laquinimod work, we think the
biggest upside for oral, oral, non-immunosuppressive agents, with clean safety and a neuroprotective profile is combination
use. BG12 could fit this profile - as does laquinimod. We are focused on BG12 EXPLORE study.
! Aloha - We are attending AAN next week to gain further insight, not just into the ALLEGRO data, but also the
neuroprotective hypothesis and concomitant advances in imaging, dynamics with the current marketed MS therapeutics,
and MS agents in development. If you would like to be added to a specific distribution list for feedback from the meeting
please email or contact your CS sales representative. |
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| From: sim1 | 6/22/2011 6:04:09 AM | | | | | | European Commission Approves Inclusion of Anti-JC Virus Antibody Status as a PML Risk Factor in TYSABRI Labeling
--Five Year Marketing Authorization for TYSABRI Also Renewed --
Message 27448280 |
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| From: mopgcw | 10/5/2011 1:01:03 PM | | | | | | Biogen MS trial data reveals no safety surprises
Wed Oct 5, 2011 6:45am EDT
* Details of DEFINE trial consistent with top-line data
* Safety profile encouraging, analysts say
* Results bode well for upcoming CONFIRM trial
By Toni Clarke
Oct 5 (Reuters) - Detailed data from a key trial of Biogen Idec Inc's ( BIIB.O) experimental multiple sclerosis drug BG-12 revealed no new safety concerns, and showed similar efficacy when given twice or three times a day, according to a summary of results to be presented at an upcoming conference.
Initial results from the trial, known as DEFINE, were released in April and showed the drug, when given twice a day, cut the annualized relapse rate by 53 percent at two years compared with placebo, and cut the rate of disability progression by 38 percent.
Biogen said at the time that the side effects were similar to those seen in an earlier, mid-stage trial, but did not elaborate.
Multiple sclerosis is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision. BG-12 is designed to treat relapsing-remitting MS, in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.
A summary of detailed data to be presented at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) later this month, and posted on the group's website late on Tuesday, did not show a meaningful difference in safety or efficacy than that seen in the initial data.
Moreover, the ECTRIMS summary showed a 48 percent reduction in annual relapse rate with three times a day dosing and a reduction in disability progression of 34 percent, in line with the results seen with twice a day dosing.
"These data confirm that the efficacy of the twice a day and three times a day arms were numerically very similar in DEFINE, and increase our confidence in the data," said Thomas Wei, an analyst at Jefferies and Company, in a research note. "We are particularly encouraged that there is no material difference in discontinuations due to adverse events."
About 16 percent of patients dropped out of the twice a day and three times a day group, compared to a rate of 13 percent for the group treated with a placebo.
Side effects included flushing of the face, which affected 38 percent of patients in the twice a day group and 32 percent in the three times a day group, compared to a rate of 5 percent in the placebo group. The incidence of serious adverse events was similar to the placebo, as was the incidence of infection.
"We view the safety profile as largely manageable," said Geoff Meacham, an analyst at J.P. Morgan, in a research note. "As of right now, BG-12's overall clinical profile does appear to be shaping up nicely."
However, Meacham noted that investors' expectations of BG-12 are relatively high, leaving Biogen little room for error.
Biogen is due to release data from a second late-stage trial of BG-12, known as CONFIRM, by the end of the year. If data from CONFIRM are positive, Biogen's shares could rise as much as 10 percent, according to some analysts, and have the potential to fall as much as 20 percent if the data disappoints.
Biogen's shares closed on Tuesday at $91.66 on Nasdaq.
Unlike most MS drugs, which are given by injection or infusion, BG-12 is taken orally. Oral drugs are expected to eventually become the most popular option for patients. So far the only oral drug to be approved in Gilenya, a drug made by Novartis AG ( NOVN.VX) that is given once a day.
Gilenya has shown a reduction in annualized relapse rates of about 54 percent.
Some analysts expect BG-12, if approved, to generate more than $1 billion in annual sales. Weston, Massachusetts-based Biogen already makes the MS drugs Avonex and Tysabri. It shares sales of Tysabri with its partner Elan Corp Plc ( ELN.I). (Reporting by Toni Clarke) |
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| To: mopgcw who wrote (1672) | 12/6/2011 5:00:18 AM | | From: nigel bates | | | | SEOUL, Korea & WESTON, Mass.--(BUSINESS WIRE)-- Samsung and Biogen Idec (NASDAQ: BIIB - News) today announced that they have entered into an agreement to invest $300 million to establish a joint venture to develop, manufacture and market biosimilars. Samsung will take a leading role in the joint venture, with Biogen Idec contributing its expertise in protein engineering and biologics manufacturing.
Under the terms of the agreement, Samsung will contribute $255 million of the $300 million for an 85 percent stake and Biogen Idec will contribute $45 million for a 15 percent stake in the joint venture. The joint venture, which will be based in Korea, will contract with Biogen Idec and Samsung Biologics for technical development and manufacturing services. Samsung Biologics is a Samsung business formed in April 2011 to specialize in biopharmaceutical manufacturing. The joint venture will not pursue biosimilars of Biogen Idec’s proprietary products.
“At Samsung, one of our goals is to help patients around the world by increasing the accessibility and affordability of existing medicines,” said Tae-Han Kim, Ph.D., CEO of Samsung Biologics. “Since many of the world’s top-selling drugs are biologics, developing and making high-quality biosimilars is critical to that goal. By combining Biogen Idec’s expertise in biologics with our business acumen and proven record of success in new business development, we are taking a significant step toward becoming a major player in the biopharmaceutical industry and investing in an important growth engine for our company.”
“The future of healthcare will continue to be driven by innovation, but it will also be about ensuring patients have access to cost-effective therapies, and biosimilars will play an important role in that,” said George A. Scangos, Ph.D., CEO of Biogen Idec. “This relationship will allow us to leverage our world-class protein engineering and biologics manufacturing capabilities, while maintaining focus on our mission of discovering, developing and delivering innovative therapies for patients worldwide with neurodegenerative diseases, hemophilia and autoimmune disorders. We are very impressed with Samsung’s track record of leadership and excellence in all their businesses and are excited to be working with them.”
Completion of the transaction is subject to customary closing conditions, including antitrust clearance by the U.S. and Korean regulators. |
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