Biogen CEO to leave as Alzheimer’s drug struggles

(Reuters) – Biogen mentioned on Tuesday its Chief Government Michel Vounatsos will step down, with the drugmaker including it might scale down its gross sales infrastructure for the controversial Alzheimer’s drug Aduhelm.

Under are the occasions to the drug’s long-winding, controversial approval final June and developments since:

2007: College of Zurich spin-off Neurimmune Therapeutics licensed unique rights of aducanumab to Biogen. (https://bit.ly/3g3MlFm)

March, 2014: Eisai Co Ltd agrees to collaborate with Biogen to develop therapies for Alzheimer’s illness, together with an choice for the Tokyo-based firm to collectively develop and commercialize aducanumab. (https://bit.ly/3JgMGRu)

March, 2015: The primary signal aducanamab might work is seen when Biogen launched interim knowledge from a small research that confirmed lowered brain-destroying amyloid plaque and slowed scientific decline in sufferers with gentle illness. (https://reut.rs/3g1HHHM)

July, 2015: Biogen’s trial of 6 milligrams of aducanumab, a dose it hoped can be efficient with out producing the mind swelling seen in larger doses, didn’t considerably gradual psychological decline. (https://reut.rs/37xO1Gx)

September, 2015: Biogen began to check aducanumab in individuals with early Alzheimer’s illness in its two international, late-stage research often called ENGAGE and EMERGE. (https://bwnews.pr/34IyKhd)

March, 2019: Aducanamab discovered unlikely to achieve success by an impartial committee monitoring its massive trials. Biogen ended the research and misplaced $18 billion in market worth. (https://reut.rs/3cax98b)

October, 2019: A brand new evaluation of two discontinued research confirmed the drug slowed development of Alzheimer’s and Biogen revived plans to hunt U.S. approval. (https://reut.rs/3pgD8gZ)

July, 2020: Biogen accomplished the submission of a biologics license software to the U.S. FDA for the approval of aducanumab. (https://bit.ly/3E1aHLu)

November, 2020: FDA workers mentioned Biogen confirmed “exceptionally persuasive” proof that aducanumab is efficient in paperwork launched forward of a gathering of out of doors consultants who thought-about whether or not to suggest approval. (https://reut.rs/3ujL4Cj)

November, 2020: The panel of out of doors advisers to the FDA disagreed with the company’s workers and voted that aducanumab had not been confirmed to gradual development of the illness. (https://reut.rs/3rd58nN)

June, 2021: The U.S. well being regulator authorized aducanumab, branded as Aduhelm, saying that the discount in amyloid plaque is more likely to gradual the speed of cognitive decline in Alzheimer’s sufferers. The company turned to an accelerated pathway designed to carry promising medicine to market shortly to allow the transfer.

June, 2021: Biogen priced the drug at $56,000 per 12 months for a mean weight individual.

June, 2021: FDA launched paperwork that exposed disagreements throughout the company over the choice to approve the drug. At the least three members from a panel of out of doors advisers to the regulator resigned in protest.

July, 2021: FDA modified its preliminary broad resolution on Aduhelm’s use to limit the drug to sufferers with gentle cognitive impairment or gentle dementia stage of Alzheimer’s. The company known as for an impartial federal probe into its interactions with Biogen.

July, 2021: Biogen recorded second-quarter gross sales of about $2 million from Aduhelm. The corporate mentioned a “massive chunk” of that income mirrored stock buildup and had not but been administered to sufferers.

August-September, 2021: U.S. lawmakers launched an investigation on the accelerated approval of the drug and requested paperwork from the FDA associated to the choice.

October, 2021: Aduhelm introduced in a lot lower-than-expected gross sales of $300,000 in its first full quarter as docs held again on utilizing the drug.

December, 2021: The European Medicines Company rejected Aduhelm, saying the hyperlink between the drug’s discount of amyloid beta and a scientific enchancment within the illness had not been established.

December, 2021: The corporate reduce the U.S. value of the drug by about half to $28,200.

January, 2022: U.S. Medicare introduced plans to cowl Aduhelm just for sufferers enrolled in a scientific trial, limiting entry to the drug.

February, 2022: The Federal Commerce Fee and the Securities and Trade Fee started investigating Biogen over the drug.

March, 2022: Tokyo-based associate Eisai cuts its position to a royalty settlement, giving up proper to share revenue from Aduhelm.

March, 2022: Biogen printed knowledge from its long-term research within the lesser-known Journal of Prevention of Alzheimer’s Illness.

April, 2022: The Facilities for Medicare and Medicaid Companies issued its ultimate protection coverage for Aduhelm.

April, 2022: Biogen mentioned it would withdraw the advertising and marketing software for the drug in Europe after failing to persuade the European regulator of the therapy’s advantages.

Could, 2022: Biogen mentioned Chief Government Officer Michel Vounatsos will step down after a successor is appointed and that it plans to “considerably” remove business infrastructure associated to Aduhelm.

(Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Enhancing by Invoice Berkrot, Peter Henderson, Sriraj Kalluvila and Krishna Chandra Eluri)