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   Biotech / MedicalBiogen


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To: mopgcw who wrote (1672)12/6/2011 5:00:18 AM
From: nigel bates
   of 1683
 
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 K3/17/2014 6:04:28 PM
   of 1683
 
BIIB to be added to the S&P 100, after the close 3/21.

finance.yahoo.com

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From: Sr K1/20/2015 4:16:13 PM
   of 1683
 
All-time high,

363.28 close
365.19 high

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From: Sr K8/1/2016 9:22:07 AM
   of 1683
 
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: Julius Wong11/7/2016 8:31:47 AM
       of 1683
     
    Biogen and Ionis Pharmaceuticals Announce SPINRAZA (nusinersen) Meets Primary Endpoint at Interim Analysis of Phase 3 CHERISH Study in Later-Onset Spinal Muscular Atrophy

    finance.yahoo.com

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    From: Issac12/2/2016 1:43:29 AM
       of 1683
     
    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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    From: Sr K1/22/2018 7:21:43 PM
       of 1683
     
    No posts since Dec 2016.

    Sanofi made an offer to buy Biogen spinoff BIVV, which rose 61.79% to more than $103.79, for $105 cash.

    finance.yahoo.com

    finance.yahoo.com

    Paris (France) and Waltham, Mass. - January 22, 2018 - Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis). The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors.

    "With Bioverativ, a leader in the growing hemophilia market, Sanofi enhances its presence in specialty care and leadership in rare diseases, in line with its 2020 Roadmap, and creates a platform for growth in other rare blood disorders. Together, we have a great opportunity to bring innovative medicines to patients worldwide, building on Bioverativ`s success in driving new standards of care with its extended half-life factor replacement therapies," commented Olivier Brandicourt, Sanofi`s Chief Executive Officer. "Combined, we will continue to leverage our scientific know-how, disciplined focus and development expertise that best position us to drive value for our shareholders and create breakthrough treatments for patients."

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    To: Sr K who wrote (1679)6/7/2021 2:59:16 PM
    From: Glenn Petersen
    1 Recommendation   of 1683
     
    Biogen shares surge 60% after FDA approves Alzheimer’s drug, the first new therapy for the disease in nearly two decades


    PUBLISHED MON, JUN 7 202111:03 AM EDT
    UPDATED 12 MIN AGO
    Berkeley Lovelace Jr. @BERKELEYJR
    CNBC.com

    KEY POINTS

    -- The FDA approved Biogen’s Alzheimer’s disease drug aducanumab.

    -- It’s the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

    -- The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company.

    The Food and Drug Administration on Monday approved Biogen’s Alzheimer’s disease drug aducanumab, making it the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

    The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company and offers new hope to friends and families of patients living with the disease.

    Biogen’s stock was halted for the announcement. The stock later resumed trading, surging more than 60% at one point, before paring that gain to a rise of 41% to $403.88.

    “We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.”

    “With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review,” Cavazzoni added.

    The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial. Biogen said Monday that aducanumab’s list price is $56,000 per year; $4,312 per infusion.

    Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. More than 6 million Americans are living with it, according to estimates by the Alzheimer’s Association. By 2050, that number is projected to rise to nearly 13 million, according to the group.

    “It is a new day,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. “This approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”

    There were previously no drugs cleared by the FDA that can slow the mental decline from Alzheimer’s, which is the sixth-leading cause of death in the United States. The agency has approved Alzheimer’s drugs aimed at helping symptoms, not actually slowing the disease itself.

    Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016.

    In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all.

    Shares of Biogen soared in November after it won backing from FDA staff, who said the company showed highly “persuasive” evidence aducanumab was effective and that it had “an acceptable safety profile that would support use in individuals with Alzheimer’s disease.”

    But two days later, a panel of outside experts that advises the U.S. agency unexpectedly declined to endorse the experimental drug, citing unconvincing data. It also criticized agency staff for what it called an overly positive review.

    When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

    Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

    Some doctors have said they won’t prescribe aducanumab if it does reach the market, because of the mixed data package supporting the company’s application.

    Supporters, including advocacy groups and family members of those living with the disease desperate for a new treatment, have acknowledged the data isn’t perfect. However, they contend it could help some patients with Alzheimer’s, a progressive and debilitating disease.

    Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease. The company has previously estimated about 1.5 million people with early Alzheimer’s in the U.S. could be candidates for the drug, according to Reuters.

    The approval is “interesting as the FDA is essentially confirming here that the beta-amyloid hypothesis has been validated,” Salim Syed, a senior biotech analyst at Mizuho Securities, said Monday, adding the decision will have major implications for future clinical trials. Some experts aren’t convinced targeting the compound will slow cognitive decline.

    The FDA decision is expected to reverberate throughout the biopharma sector, RBC Capital Markets analyst Brian Abrahams said in a note to clients on June 1.

    That forecast was seemingly backed up by comments Monday from Dr. Vas Narasimhan, CEO of Novartis.

    “I think it’s a reflection of the immense unmet need of these patient populations that regulators are looking for ways to bring therapeutics forward, and it certainly opens up doors,” Narasimhan said in an interview on CNBC’s “ The Exchange.”

    “We have a big neurodegenerative research and development operation and certainly we’ll be putting pens to paper — or, at least, banging on our computers — over the weekend ahead to really think about how we can accelerate our own programs.”

    The FDA said Monday it determined there was “substantial evidence” the drug helps patients. “As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease,” it said.

    – CNBC’s Kevin Stankiewicz contributed to this report.

    Biogen’s Alzheimer’s drug approved by FDA, first new therapy in nearly two decades (cnbc.com)

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    From: Sr K6/7/2021 4:38:37 PM
    1 Recommendation   of 1683
     
    Excerpt

    FDA Approves First New Alzheimer’s Drug in Nearly Two Decades

    Biogen drug approved after facing doubts over whether it slows progression of memory-robbing disease


    The approval of Aduhelm comes at a critical time for its maker Biogen.PHOTO: ERIN CLARK/BOSTON GLOBE/GETTY IMAGES

    By
    Joseph Walker

    Updated June 7, 2021 4:11 pm ET

    U.S. health regulators approved the first new Alzheimer’s drug in nearly two decades, casting aside doubts about the therapy’s effectiveness.

    The approval Monday of the therapy, which has the molecular name aducanumab and will be sold as Aduhelm, marked a watershed in Alzheimer’s drug research after billions of dollars in investment. Maker Biogen Inc. developed the therapy to do what previously approved Alzheimer’s medicines can’t: slow the memory-robbing march of the disease.

    The U.S. Food and Drug Administration, explaining its decision, said scientific evidence indicated Aduhelm reduces a sticky substance in the brain called amyloid—which is associated with Alzheimer’s—and is likely to produce a benefit to patients.

    The drug’s sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options for treatment. Yet Aduhelm’s impact may be limited. Doctors who say they will prescribe the drug caution it won’t help all patients, particularly those with more advanced disease. Some patients eligible for treatment may face $10,000 or more in annual out-of-pocket costs, health insurer Cigna Corp. estimates.

    Excerpt

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    From: Glenn Petersen6/11/2021 6:05:26 AM
    2 Recommendations   of 1683
     
    Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

    PUBLISHED THU, JUN 10 20215:14 PM EDT
    UPDATED THU, JUN 10 20217:04 PM EDT
    Berkeley Lovelace Jr. @BERKELEYJR
    CNBC.com

    KEY POINTS

    -- A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm,

    -- CNBC has learned.Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

    A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

    Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

    “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

    Evidence to approve of Biogen’s Alzheimer’s drug was not ‘sufficient,’ says Penn’s Dr. Jason Karlawish

    He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

    “This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he said.

    Shares of Biogen surged 38% on Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

    Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

    The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer’s patients. The agency granted approval on the condition that Biogen conducts another clinical trial.

    The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

    At least two other FDA panel members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter have also submitted resignation letters.

    “I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters. “I don’t wish to be put in a position like this again.”

    Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016.

    In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all.

    When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

    Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

    Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

    – Reuters contributed to this report.

    Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug (cnbc.com)

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