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Biogen Abandons Aduhelm, Searches for New CEO
- Posted by ISPE Boston
- On May 5, 2022
In reporting its first quarter 2022 results, Biogen announced that it has begun a search for a new CEO. Michel Vounatsos, who has held the position since 2017, will continue to serve as CEO and on the Board of Directors until his successor is appointed. The company also announced it will “substantially eliminate its commercial infrastructure supporting [Alzheimer drug] Aduhelm, retaining minimal resources to manage patient access programs…”
“We executed on our core business objectives in the first quarter, and we will now look forward and execute on a set of near-term operational priorities, which we believe will drive renewed growth and value creation over time,” said Vounatsos. “We have a strong balance sheet, enabling us to advance a broad pipeline that includes lecanemab in Alzheimer’s disease and zuranolone in depression, while also pursuing new internal and external growth opportunities.”
In April 2022 the Centers for Medicare & Medicaid Services (CMS) announced the final national coverage determination (NCD) for FDA approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, including Aduhelm, which included significant. restrictions on coverage. Biogen expects to continue funding certain regulatory and R&D activities for Aduhelm. Additional actions may be informed by upcoming data readouts expected for this class of antibodies, as well as further engagement with the FDA and CMS. The Phase 3 readout for lecanemab is expected in the fall of 2022, and Biogen is committed to working closely with Eisai on its potential launch. (Source: Biogen Website, 03 May, 2022)
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