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   Biotech / MedicalBiogen


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From: Sr K1/22/2018 7:21:43 PM
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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 1684
 
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 1684
 
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 1684
 
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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From: Sr K1/11/2022 4:53:43 PM
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Medicare to Pay for Biogen’s New Alzheimer’s Drug in Clinical-Trial Patients

The Centers for Medicare and Medicaid Services said it will cover the cost of the drug Aduhelm, but as part of further clinical testing


Biogen initially launched the drug at an average price per patient of $56,000 annually but recently slashed the price in half.PHOTO: CJ GUNTHER/SHUTTERSTOCK

By
Joseph Walker

Jan. 11, 2022 4:46 pm ET

Medicare officials said they would cover Biogen Inc.’s BIIB 2.64%controversial Alzheimer’s disease drug Aduhelm as part of randomized clinical trials.

The clinical trials are intended to gather evidence on the drug’s safety and effectiveness and would apply to similar drugs if they are approved, the Centers for Medicare and Medicaid said in a proposed policy issued Tuesday.

Patients enrolling in trials supported by the National Institutes of Health would also be eligible for coverage, according to CMS’s draft policy.

CMS said the Aduhelm studies must limit enrollment to patients in the early-stages of disease and have lab tests confirming that their brains have accumulated amyloid, a sticky protein linked to Alzheimer’s disease that Aduhelm is designed to clear.

Aduhelm has faced widespread criticism since its approval in June, in part because concerns that its price would balloon Medicare drug spending if millions of patients start taking it.

Biogen initially launched the drug at an average price per patient of $56,000 annually, but recently backtracked and slashed the list price in half to $28,200.

Exc,

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From: Sr K3/14/2022 7:26:33 PM
   of 1684
 
Biogen And Eisai Rewrite Alzheimer’s Drug Marketing Pact

Eisai is giving up its share in profit from the drug Aduhelm, and instead will get royalties from Biogen


Alzheimer’s drug Aduhelm was approved last year in the U.S.PHOTO: POOL NEW/VIA REUTERS

By Joseph Walker Follow

March 14, 2022 7:00 pm ET

Japan’s Eisai Co. is giving up its right to share in profits from Aduhelm, the new Alzheimer’s disease drug it helped develop with Biogen Inc., in the latest sign of the drug’s diminished financial prospects.

Biogen and Eisai said on Monday that they amended their collaboration agreement to give Biogen full authority to make regulatory and sales decisions regarding Aduhelm, which was approved last year in the U.S. in a controversial decision by the Food and Drug Administration.

Under the new terms, Eisai starting next year will surrender its right to share in profit and losses related to Aduhelm.

Beginning in 2023, Eisai will receive royalties starting at 2% of Aduhelm’s global sales, increasing as sales rise, reaching 8% when Aduhelm’s sales exceed $1 billion annually, the companies said.

The sales outlook for Aduhelm has diminished significantly since the drug was first approved last June. Health-insurers have balked at paying for it and many doctors have declined to prescribe it.

Medicare, the federal health insurance program for people over 65, has proposed to pay for Aduhelm only in narrow circumstances where patients are enrolled in randomized clinical trials. In December, health regulators in Japan and the European Union declined to approve Aduhelm.

Analysts project 2022 Aduhelm sales of $33.8 million, according to FactSet.

The companies said the financial terms of their partnership to develop a different Alzheimer’s drug, lecanemab, would remain unchanged. Eisai is responsible for leading the regulatory approval process for lecanemab globally, and Biogen is entitled to 50% of profits and losses related to the drug.

Eisai began submitting data to the FDA last year to support an early approval for lecanemab. The companies extended their agreement for Biogen to manufacture the drug from five years to 10 years.

“We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both Aduhelm and lecanemab,” said Eisai Chief Executive Haruo Naito.

The revised agreement will give Biogen greater flexibility to react to market dynamics related to Aduhelm, including the pending Medicare coverage decision, Biogen Chief Financial Officer Michael McDonnell said in an interview. The revised deal terms won’t affect Biogen’s financial outlook for 2022, he said.

“It gives Biogen increased operational efficiency and the ability to be a bit more agile to address market conditions,” Mr. McDonnell said. “It gives Eisai the ability to increase its focus on lecanemab, and increase its efforts there.”

Under the companies’ old Aduhelm agreement, Biogen led the regulatory approval process except for in Japan.

Exc.

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