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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

Moderna says vaccine generates promising immune response in opposition to variants

Moderna says vaccine generates promising immune response against variants

A doctor draws a syringe of Moderna’s vaccine.

Oliver Berg | Image Alliance | Getty Images

A booster of Moderna’s Covid-19 vaccine triggered a promising immune response against variants B.1.351 and P.1, which were first identified in South Africa and Brazil, respectively, the company announced on Wednesday, citing early data from an ongoing clinical study.

In the study, Moderna is testing a 50 microgram dose of its vaccine in previously vaccinated people. The booster dose was found to increase neutralizing antibody responses against the original virus, as well as against B.1.351 and P.1, two variants that have since spread to other countries, including the United States

The company also said that a booster shot of its other vaccine, which it calls mRNA-1273.351, produced an even better immune response over its current vaccine against the B.1.351 variant from South Africa. The new vaccine is a variant-specific booster shot that targets B.1.351.

The preliminary results, which Moderna says will be published online, have not yet been peer-reviewed.

“As we seek to defeat the ongoing pandemic, we continue to seek to be proactive as the virus evolves,” said Stephane Bancel, CEO of Moderna, in a press release. “We are encouraged by this new data, which increases our confidence that our booster strategy should protect against these newly discovered variants.”

According to Moderna, the side effects were similar to those seen after the second dose of the vaccine in the previously reported studies. Side effects included injection site pain, fatigue and headache, and muscle and joint pain.

The new data comes as drug makers and scientists now say people will likely need a booster shot of Covid-19 vaccines and possibly additional shots each year, just like they did with seasonal flu.

Moderna’s vaccine requires two doses four weeks apart. As with Pfizer and Johnson & Johnson, the shot against Covid is very effective, although company executives and officials now say they expect this strong protection to wear off over time. Pfizer’s vaccine is also a two-dose therapy, while the J&J immunization is just one burst.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, previously said that Americans may need booster vaccinations to better protect themselves from variants.

Earlier Wednesday, US health officials said highly contagious variants are still a “wild card” in their nationwide campaign to vaccinate most American adults by July 4th.

A report by the Centers for Disease Control and Prevention published on Wednesday predicted that Covid-19 cases will increase until May due to the highly contagious variant B.1.1.7 first identified in the UK, before declining sharply by July, because vaccinations reduce infections. Still, variants threaten to reverse the nation’s progress, officials said,

“We are seeing that our current vaccines protect against the pollutants circulating in the country. Put simply, the sooner more people are vaccinated, the sooner we will all get back to normal,” said CDC Director Dr. Rochelle Walensky during a Covid press conference at the White House.

Moderna is evaluating three approaches to increasing immunity. The first approach would use variant-specific booster vaccinations such as mRNA-1273.351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine into a single shot at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.

Bancel told CNBC last month that the company is hoping to have a booster shot for its two-dose vaccine in the fall.