For accounting purposes, Biogen says its $223 million inventory of Aduhelm is basically worthless – Endpoints News

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The battle over whether Biogen’s Alzheimer’s drug Aduhelm actually helps patients may never end, but in a recent SEC filing, Biogen, at least for accounting purposes, now says its reservation Aduhelm’s $230 million should be considered worthless.

In addition to scrapping all business infrastructure around the sale of Aduhelm and laying off more than 1,000 people in the process, the big biotech said in a filing with the SEC last night: “As of June 30, 2022, our ADUHELM’s total inventory was de minimis. As of December 31, 2021, we had approximately $223.0 million of ADUHELM inventory.

A Biogen spokesperson confirmed that the $223 million inventory “has not been destroyed and that Aduhelm continues to be available to commercial patients in the United States as well as our clinical trial participants. “.

But it’s still unclear how Biogen can continue to enroll patients in its confirmatory trial, mandated under fast-track FDA approval last summer, when for accounting purposes it says its inventory of products is not worth a fraction of what it was just six months ago.

“We plan to continue funding certain regulatory and research and development activities for ADUHELM, including the continuation of the EMBARK re-dosing study and the initiation of the Phase 4 post-marketing requirements study, ENVISION,” the company said in the SEC filing, noting that additional actions regarding Aduhelm may be forthcoming and “may be informed by future data readings. [e.g. lecanemab da­ta com­ing in the fall] expected for this class of antibodies, as well as further engagement with the FDA and CMS.

The spokesperson added that the inventory levels “have been written off from an accounting perspective given that NCD’s final decision effectively denies all Medicare beneficiaries access to Aduhelm.”

Meanwhile, the U.S. House of Representatives Oversight and Energy and Commerce Committees, as well as the HHS Inspector General’s Office, continue to investigate how Aduhelm obtained the approval, the company said.

Additionally, Biogen offered more color on the SEC and FTC investigations into Aduhelm, noting in its filing yesterday that it received a request for a civil investigation from the FTC and a subpoena from the SEC requesting information related to Aduhelm, including healthcare sites that use it. , licensing and marketing.

According to the revelations, the company and its partner Eisai spent more than $370 million in 2021 and 2022 on sales and marketing for Aduhelm, along with another $170 million in development spending.

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