The introduction of Biogen Aduhelm in Korea is also unclear

CEO resigns after first quarter earnings report Aduhelm is responsible for poor performance

Minimize commercial infrastructure

There's a growing possibility that the Food and Drug Administration refuses to refuse approval

Biogen has decided to minimize the commercialization infrastructure of the Alzheimer's drug Aduhelm and focus on developing subsequent drugs.

 

In fact, it is unclear whether Aduhelm, which is in the process of eviction, will be introduced in Korea.

 

Biogen announced in its first-quarter earnings announcement on the 3rd (local time) that CEO Michel Vounatsos will resign due to responsibility for Aduhelm.

 

CEO Michel Vounatsos will retire as soon as a successor is decided.

 

At the same time, what attracts attention is the announcement that it will drastically reduce Aduhelm's commercial infrastructure.

 

Biogen said it minimizes all infrastructure for Aduhelm's commercialization.

 

In the previously announced $500 million annual cost reduction plan, it will save an additional $500 million.

 

In fact, it is interpreted as a decision to give up the commercialization of Aduhelm.

 

Biogen's move to give up Aduhelm is pointed out as the decisive background for the rise to the surface of the water, which is the restriction on the application of Aduhelm insurance by Medicare, a U.S.

 

public health insurance.

 

CMS in the U.S.

 

made a final decision last month to apply insurance benefits only to patients who participated in clinical trials of Aduhelm.

 

CEO Michel Vounatsos said in a performance announcement, "This decision is very disappointing as it virtually rejects Aduhelm from all Medicare subscribers." "As a result, Biogen will substantially eliminate commercial infrastructure for Aduhelm," he said.

 

Aduhelm is also increasing the financial burden on the company.

 

Biogen said it was negatively affected by $275 million in inventory amortization costs for Aduhelm and $45 million in idle capacity costs in the first quarter.

 

Instead, Biogen plans to accelerate the development of follow-up drugs.

 

The subsequent drug is another new Alzheimer's drug, Lecanemab.

 

It is being developed jointly with Eisai and Biogen plans to begin the process for Lecanemab's acceleration approval this year.

 

The pharmaceutical bio industry interprets that Biogen's decision has also made it unclear about the commercialization of Aduhelm in Korea.

 

Biogen had already voluntarily withdrawn Aduhelm's application for European permission in April.

 

After the EMA refused to approve Aduhelm in December last year, it reapplied for approval, but soon voluntarily decided to withdraw it.

 

Biogen applied for Aduhelm from the MFDS in July last year.

 

It is predicted that the MFDS, which has currently started the screening for Aduhelm, has possibilities to refuse the permission by referring to EMA's decision.

 

However, Biogen expressed its original position, saying that it has not changed its domestic commercialization plan.

 

An official from Biogen said, "We confirmed the decision of the global headquarters through the article, and there were no guidelines for commercialization in Korea."