Tag: Biogens

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Health

Biogen’s controversial Alzheimer’s drug generates $2 million gross sales in first few weeks after approval

Biogen's controversial Alzheimer’s drug generates $2 million sales in first few weeks after approval

Aduhelm from Biogen

Source: Biogen

Biogen’s Alzheimer’s drug Aduhelm made $ 2 million in sales in the first few weeks after its approval, the company said Thursday when it released its second quarter results along with an open letter about the controversial drug.

Biogen increased its sales guidance for the year and expected total sales for the year of $ 10.65 billion to $ 10.85 billion. That’s an increase from its earlier estimates of $ 10.45 billion to $ 10.75 billion. The new forecast assumes “modest” income for Aduhelm in 2021, which will then be ramped up, the company said.

Here’s how Biogen performed in the three months ended June 30, compared to Wall Street’s expectations, according to Refinitiv’s average estimates:

  • Adjusted earnings per share: $ 5.68 versus $ 4.54 expected
  • Revenue: $ 2.78 billion versus an expected $ 2.61 billion

The company’s stock rose slightly in early trading.

Aduhelm was approved by the Food and Drug Administration on June 7th. The drug, scientifically known as aducanumab, offers new hope to friends and families of patients living with the disease and is set to generate billions in revenue for the company.

However, its approval has since been questioned, and the head of the FDA is now calling for a state investigation into the interactions between agency employees and the biotech company.

Biogen’s Chief Research Officer, Dr. Al Sandrock, defended the drug in an open letter released Thursday along with the company’s profits, saying its approval was subject to “extensive misinformation and misunderstanding”.

He said it was “normal” for scientists and clinicians to discuss and debate data from experimental and clinical trials, but added that those discussions had taken a turn “outside the boundaries of legitimate scientific reasoning”.

“We welcome a formal review of the interactions between the FDA and Biogen in the process of obtaining aducanumab approval,” said Sandrock. “A better understanding of the facts is good for everyone involved in building confidence in the therapy and the approval process as we prioritize the issues that affect patients.”

Correction: In an earlier version, Aduhelm was misspelled.

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Health

Biogen’s Alzheimer’s drug may value Medicare billions of {dollars} a yr: report

Biogen's Alzheimer's drug could cost Medicare billions of dollars a year: report

A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts on Monday, June 7, 2021.

Adam Glanzman | Bloomberg | Getty Images

Biogen’s expensive new Alzheimer’s drug Aduhelm could cost Medicare billions of dollars, according to an analysis published Thursday by the nonprofit Kaiser Family Foundation.

The Food and Drug Administration on Monday approved the company’s drug, the first U.S. regulator-approved drug to slow cognitive decline in people with Alzheimer’s and the first new drug for the disease in nearly two decades.

The biotech company said it charges $ 56,000 for an annual course of the new treatment, which is higher than the $ 10,000-25,000 price some Wall Street analysts were expecting. This is the wholesale price, and the cost that patients actually pay depends on their health insurance plan.

It is estimated that Alzheimer’s disease affects more than 6 million Americans, the vast majority of whom are 65 years of age and older. Biogen estimates that about 80% of Alzheimer’s patients are covered by Medicare, the state health insurance for the elderly.

It is still unclear how many Medicare beneficiaries will take Biogen’s drug, but even a conservative estimate would result in a “substantial increase” in Medicare spending, according to KFF.

In 2017, nearly 2 million Medicare beneficiaries were using one or more Alzheimer’s treatments that are covered under Medicare Part D, according to KFF. The group said if a quarter of those beneficiaries were instead prescribed Aduhelm, and Medicare paid 103% of $ 56,000 in the near future, “the total spending on Aduhelm in a year alone will be nearly $ 29 billion”.

According to the KFF, Aduhelm is covered by Medicare Part B, which generally covers FDA-approved, physician-administered drugs.

“If 1 million Medicare beneficiaries received Aduhelm, which may be on the lower end of Biogen’s expectations, spending for Aduhelm alone would exceed $ 57 billion in a single year – well above anything else covered by Part B. Medication together, ”group said. The total spend for Part B in 2019 was $ 37 billion.

Biogen has been criticized by Wall Street analysts and advocacy groups for questioning how the company could justify the price, especially as medical experts continue to debate whether there is enough evidence that the drug actually works and criticize the industry for drug prices becomes.

On a call to investors Tuesday morning, Evercore ISI analyst Umer Raffat congratulated the Massachusetts-based company on US approval of the drug before asking executives to explain the price.

“I think there is a discrepancy between some of the words you shared in your press releases like responsibility, access, health equity, and price, especially given the basic care population,” he told executives.

Biogen executives said Tuesday the overall price of the new treatment was “underpinned” by the value it is expected to bring to patients, caregivers and society. They insisted that the price was “responsible” and stated that the disease costs the US billions each year.

The company has pledged not to increase the price of the new drug over the next four years. However, executives said they were “open-minded” and suggested reconsidering price as the company assesses demand over the next few years.

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World News

Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

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.

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.”

Shares of Biogen surged 38% 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.

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.

This is a developing story. Please check back for updates.

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Health

Biogen’s Alzheimer’s drug accredited by FDA, first new remedy in almost 20 years

Biogen’s Alzheimer’s drug approved by FDA, first new therapy in nearly two decades

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

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

Biogen stock was on hold for the announcement. The stocks later resumed trading, rising more than 60% at times before reducing that gain by 40% to $ 400.83.

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

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

The FDA said it would continue to monitor the drug when it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical study. The Massachusetts-based biotechnology company announced Monday that the list price of aducanumab is $ 56,000 a year; $ 4,312 per infusion.

Biogen CEO Michel Vounatsos told CNBC’s “Power Lunch” later Monday that he thought the price of the drug was “fair,” but also vowed the company would not raise its price for four years.

It reflects “two decades without innovation” and will also allow the company to continue investing in its pipeline of drugs for other diseases, he said.

Alzheimer’s disease is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates that more than 6 million Americans live with it. According to the group, this number is expected to rise to almost 13 million by 2050.

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

To date, there have been no FDA-approved drugs that can slow the mental decline of Alzheimer’s, the sixth leading cause of death in the United States. The agency has approved Alzheimer’s drugs that are aimed at relieving symptoms rather than slowing the disease itself down.

Federal agencies have come under intense pressure from friends and family members of Alzheimer’s patients to speed up aducanumab, but the road to regulatory approval has been controversial since it showed promise in 2016.

In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. The company then shocked investors a few months later by announcing that it would apply for regulatory approval for the drug after all.

Biogen’s shares soared in November after the company received support from FDA officials who said the company had very “compelling” evidence of aducanumab’s effectiveness and “an acceptable safety profile that would make its use in individuals would assist with Alzheimer’s disease “, submitted.

But two days later, a panel of external experts advising the US agency unexpectedly declined to approve the experimental drug, citing inconclusive data. It also criticized the agency’s staff for rating it too positively.

When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”

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

Some doctors have said they won’t prescribe aducanumab when it hits the market because the mixed data package helps the company’s use.

Supporters, including advocacy groups and family members of patients desperately looking for a new treatment, have admitted the data is not perfect. However, they claim 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 that scientists expect to play a role in the devastating disease. The company previously estimated that approximately 1.5 million people with early-stage Alzheimer’s in the United States could be candidates for the drug, according to Reuters.

The approval is “interesting because the FDA is essentially confirming that the beta-amyloid hypothesis has been validated,” said Salim Syed, a senior biotech analyst at Mizuho Securities, on Monday, adding that the decision had a major impact will have future clinical trials. Some experts are not convinced that targeting the compound will slow cognitive decline.

The FDA’s decision is expected to reverberate across the biopharmaceutical sector, RBC Capital Markets analyst Brian Abrahams said in a June 1 announcement to customers.

That prognosis was apparently confirmed on Monday by comments from Dr. Vas Narasimhan, CEO of Novartis, confirmed.

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

“We have a lot of neurodegenerative research and development and will certainly be putting pens on paper – or at least hammering on our computers – this coming weekend to really think about how we can speed up our own programs.”

The FDA said Monday it found there was “substantial evidence” that the drug is helping patients. “With Aduhelm approved by the FDA, an important and critical new treatment is available to patients with Alzheimer’s disease to combat the disease,” the statement said.

– CNBC’s Kevin Stankiewicz contributed to this report.