| 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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| From: Sr K | 8/1/2016 9:22:07 AM | | | | | | on Briefing.com
Ionis Pharma (IONS 36.48, +7.29): +25.0% after Biogen (BIIB 302.00, +12.07) paid the company a $75 million licensing fee following positive Phase-3 trial results of nusinersen
The analysis found that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment.
Nusinersen demonstrated an acceptable safety profile in the trial.
As a result of these findings,
Biogen has exercised its option to develop and commercialize nusinersen globally and paid Ionis a $75 million license fee.Biogen will initiate regulatory filings globally in the coming months.
Based on the results of the pre-specified interim analysis, the ENDEAR study will be stopped and participants will be able to transition into the SHINE open-label study in which all patients receive nusinersen.
Data from the other endpoints of ENDEAR will be analyzed when the full data set is available.
Biogen is now responsible for all nusinersen development, regulatory and commercialization activities and costs. Ionis will complete the Phase 3 studies and work with Biogen on regulatory filings.
The two cos will also work together to transition the clinical programs that Ionis is conducting to Biogen.
Ionis is eligible to receive tiered royalties on any potential sales of nusineren up to a percentage in the mid-teens, in addition to up to $150 million in milestone payments based on regulatory approvals.
Cos will host a live webcast to discuss the results of the Phase 3 ENDEAR interim results for nusinersen today, August 1, 2016, from 9:00 to 9:30 a.m. EDT. |
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| From: Issac | 12/2/2016 1:43:29 AM | | | | | | | BIIB Stock: Unexpected Sell-Off Biogen Inc (NASDAQ:BIIB) stock is down 5.91% on the back of news surrounding a clinical drug failure from one of its competitors, Eli Lilly and Co (NYSE:LLY). |
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