Post by icemandios on Nov 17, 2021 16:24:47 GMT
UPDATED: European drug regulator votes down Biogen's controversial Alzheimer's drug
Zachary Brennan
Senior Editor
Following an oral explanation held at the November meeting of the EMA’s human medicines committee, Biogen received “a negative trend vote” on its marketing application for its controversial Alzheimer’s drug aducanumab, the company said Wednesday morning.
The setback is just the latest in a string of negatives — from an anemic launch to rejection of coverage from the VA — since the surprising June approval of the drug by the FDA that led to multiple resignations from an advisory committee that unanimously rejected it.
“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen.
The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting, Biogen said.
The company’s stock was down about 4% on the announcement, which is on top of another 4% drop yesterday on Monday evening’s news of its top R&D leader Al Sandrock’s decision to leave Biogen at the end of the year.
RBC’s Brian Abrahams notes today that the likely slapdown in Europe will effectively eliminate 40% of the potential revenue Biogen can get from the drug.
We do not necessarily see any direct read throughs to U.S. regulatory or access consideration; however, less global experience with and acceptance of the agent may perpetuate U.S. physician skepticism and further hamper uptake.
BIIB’s Alzheimer’s franchise is becoming increasingly dependent on lecanemab, in our view, with key pivotal ph.III data for that drug expected 2H22. Positive data would provide key validation for the class and enable an entry in the Alzheimer’s space with potential better benefit/risk and an opportunity to price more reasonably; negative data would further damage perceptions around the class and potential adu usage.
BOTTOM LINE: BIIB remains a company in transition, with key risks to its existing franchises and future growth drivers.
Biogen’s shares are now trading at levels we haven’t seen since before the stunning approval of a drug that has inspired heated criticism from a legion of experts, who will now be joined by their counterparts in Europe. Biogen CEO Michel Vounatsos added to the company’s woes by charging $56,000 for the drug, which got an accelerated OK based primarily on disputed biomarker data. Now Medicare is boosting the cost of one drug program to seniors in anticipation of what may come if the drug begins to gain traction among desperate patients with Alzheimer’s.
Biogen’s rivals in Alzheimer’s, primarily Roche and Eli Lilly for now, are both lining up regulatory pitches for their own therapeutics, with Roche execs talking up the possibility of a deep discount over that $56,000 price. If they manage a quick leapfrog with lower-priced drugs, Biogen may ultimately get little of the multibillion-dollar fortune analysts are convinced await any company that can successfully penetrate this market.
Meanwhile, CMS is implementing a 14.55% hike in the Part B premium in case they decide to cover the cost of Aduhelm despite the VA and the EU refusals. Which means, if CMS does cover it, the Part B premium will go from 148.50/mo to 170.10/mo. And if they decide not to cover it, the Part B premium will go from 148.50/mo to 170.10/mo. ("pay your fair share").
CMS Announces 2022 Medicare Part B Premiums
Zachary Brennan
Senior Editor
Following an oral explanation held at the November meeting of the EMA’s human medicines committee, Biogen received “a negative trend vote” on its marketing application for its controversial Alzheimer’s drug aducanumab, the company said Wednesday morning.
The setback is just the latest in a string of negatives — from an anemic launch to rejection of coverage from the VA — since the surprising June approval of the drug by the FDA that led to multiple resignations from an advisory committee that unanimously rejected it.
“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen.
The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting, Biogen said.
The company’s stock was down about 4% on the announcement, which is on top of another 4% drop yesterday on Monday evening’s news of its top R&D leader Al Sandrock’s decision to leave Biogen at the end of the year.
RBC’s Brian Abrahams notes today that the likely slapdown in Europe will effectively eliminate 40% of the potential revenue Biogen can get from the drug.
We do not necessarily see any direct read throughs to U.S. regulatory or access consideration; however, less global experience with and acceptance of the agent may perpetuate U.S. physician skepticism and further hamper uptake.
BIIB’s Alzheimer’s franchise is becoming increasingly dependent on lecanemab, in our view, with key pivotal ph.III data for that drug expected 2H22. Positive data would provide key validation for the class and enable an entry in the Alzheimer’s space with potential better benefit/risk and an opportunity to price more reasonably; negative data would further damage perceptions around the class and potential adu usage.
BOTTOM LINE: BIIB remains a company in transition, with key risks to its existing franchises and future growth drivers.
Biogen’s shares are now trading at levels we haven’t seen since before the stunning approval of a drug that has inspired heated criticism from a legion of experts, who will now be joined by their counterparts in Europe. Biogen CEO Michel Vounatsos added to the company’s woes by charging $56,000 for the drug, which got an accelerated OK based primarily on disputed biomarker data. Now Medicare is boosting the cost of one drug program to seniors in anticipation of what may come if the drug begins to gain traction among desperate patients with Alzheimer’s.
Biogen’s rivals in Alzheimer’s, primarily Roche and Eli Lilly for now, are both lining up regulatory pitches for their own therapeutics, with Roche execs talking up the possibility of a deep discount over that $56,000 price. If they manage a quick leapfrog with lower-priced drugs, Biogen may ultimately get little of the multibillion-dollar fortune analysts are convinced await any company that can successfully penetrate this market.
Meanwhile, CMS is implementing a 14.55% hike in the Part B premium in case they decide to cover the cost of Aduhelm despite the VA and the EU refusals. Which means, if CMS does cover it, the Part B premium will go from 148.50/mo to 170.10/mo. And if they decide not to cover it, the Part B premium will go from 148.50/mo to 170.10/mo. ("pay your fair share").
CMS Announces 2022 Medicare Part B Premiums