Breaking News
0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Biogen says uptake on new Alzheimer's drug slower than expected

Stock MarketsJul 22, 2021 12:37PM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder

By Manas Mishra and Michael Erman

(Reuters) -Biogen Inc on Thursday said getting hospitals and clinics to use its new Alzheimer's disease drug Aduhelm and insurers to reimburse it has been slower than it expected, as controversy mounts over the U.S. Food and Drug Administration's approval process for the treatment.

The Cambridge, Massachusetts-based drugmaker's top scientist also defended the science behind the approval as well as the company's interactions with U.S. regulators before the FDA's June 7 action https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-set-rule-controversial-biogen-alzheimers-drug-2021-06-07.

The FDA's acting commissioner, Janet Woodcock, has asked the Department of Health and Human Services' internal watchdog office to investigate https://www.reuters.com/business/healthcare-pharmaceuticals/fda-calls-federal-investigation-into-approval-biogens-alzheimers-drug-2021-07-09 whether talks between Biogen (NASDAQ:BIIB) and the agency were consistent with the regulator's policies.

Aduhelm, administered through an infusion, was approved despite one of its two large-scale clinical trials failing to show a benefit to patients. The approval was based on evidence that Aduhelm can reduce brain plaques, a likely contributor to Alzheimer's disease, rather than evidence demonstrating that it slows progression of the lethal mind-wasting disease.

Biogen's head of research and development, Alfred Sandrock, said in a conference call with investors that he believes that ongoing studies being conducted by the company, including one required by the FDA after the approval, would show that reducing these plaques could help slow cognitive decline associated with the disease.

Some prominent doctors, hospitals and health insurers have criticized the FDA's approval and said they will not offer the drug, including the Cleveland Clinic and New York's Mount Sinai Health System.

"A few centers have indicated that they will not provide access to Aduhelm for now. Now remember though, many of these physicians can still prescribe the drug, and they have asked for support to find alternative sites where they can infuse their patients," Alisha Alaimo, president of Biogen US, said on the call.

'A BIT SLOWER'

Biogen had previously said 900 medical centers would be ready to administer the drug shortly after its launch. So far, 35% of those sites have either completed a review and approved it for use or indicated they will not need a review of the drug.

"Overall, it's a bit slower than what we assumed, but we are making tremendous progress with some positives and some headwinds," Chief Executive Michel Vounatsos said.

Stifel analyst Paul Matteis said some doctors or medical centers may be hesitant to build inventory considering they will not know how they will be reimbursed unless Medicare sets a standardized policy for coverage of the drug.

Medicare, the government healthcare program for people over age 65, this month launched a nine-month process to formulate standardized national coverage terms for Aduhelm. For now, claims are being handled by Medicare's regional offices.

Medicare held its first public hearing on the topic on Thursday.

"The main factor delaying treatment is uncertainty about coverage," Dr. Stephen Salloway of Brown Medical School and Butler Hospital in Providence, Rhode Island, said during the hearing.

"I'm concerned that patients who may benefit will not have access to treatment during the nine months prior to the NCD (national coverage decision) and may not be eligible for treatment later," Salloway added.

Biogen said it expects modest revenue from Aduhelm this year and to ramp up thereafter, adding that it is seeing "strong indications of very high initial patient interest as well as increased referrals."

The drug brought in revenue of $2 million in the first few weeks since its approval, below expectations of $3.23 million. A "big chunk" of that revenue so far reflects product that had been shipped to customers as inventory and had not yet been administered to patients, Vounatsos said.

In an open letter https://investors.biogen.com/news-releases/news-release-details/open-letter-alzheimers-disease-community-our-head-research-and, Sandrock said the drug's approval process "has been the subject of extensive misinformation and misunderstanding."

"It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data," Sandrock wrote.

In its earnings report issued on Thursday, Biogen raised its forecast for total sales to $10.65 billion to $10.85 billion this year, from $10.45 billion to $10.75 billion previously.

Biogen shares were up 1.6% at $328.27 in midday trading.

Biogen says uptake on new Alzheimer's drug slower than expected
 

Related Articles

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Comments (1)
Me comment
Me comment Jul 22, 2021 10:29AM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
What do they expect the drug doesn't work.
Saroop Calvete
Saroop Calvete Jul 22, 2021 10:29AM ET
Saved. See Saved Items.
This comment has already been saved in your Saved Items
Exactly, they still ignore the pathogenesis of the disease and they yet claim that reducing plaques will improve the clinical signs.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email