Biogen Inc. is quitting development and sales of Aduhelm (aducanumab-avwa), the controversial Alzheimer’s disease (AD) therapy given accelerated approval by the U.S. FDA in the summer of 2021. The phase III Envision study with the amyloid-beta directed antibody will be stopped. Cambridge, Mass.-based Biogen has recorded a one-time charge of about $60 million related to close-out costs for the program in the fourth quarter of 2023. AD efforts with Leqembi (lecanemab-irmb), also an amyloid-beta directed antibody, will continue. The drug was cleared for marketing in January of 2023 and is partnered with Eisai Co. Ltd. Shares of Biogen (NASDAQ:BIIB) were trading midday at $250.59, up $3.11.
Europabio: Proposed EU legislation risks sabotaging innovation
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector. The proposed changes, which include reduced market exclusivity periods, will send a clear message to health investors worldwide that the EU has deprioritized innovation, said the pan-European industry body Europabio, which commissioned the report.
Rare disorders pay off for Blueprint, Acadia, amid BDDI’s 2023 decline
In 2023, the BioWorld Drug Developers Index (BDDI) concluded the year down 11.35%. Although its performance trailed behind the Nasdaq Biotechnology Index (up 3.74%) and the Dow Jones Industrial Average (up 13.7%), BDDI nonetheless made a recovery from the end of October when it was down 31.4%. Notably, the top two performers on BDDI had stock rises attributed to approvals in rare disorders.
US SEC sticks to perpetual gag rule in settlements
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court. However, a strong dissent to yesterday’s commission vote, and the New Civil Liberties Alliance (NCLA) petition itself, provide a litigation map should anyone choose to challenge the policy. While several other federal agencies allow parties to settle with a statement of no wrongdoing, the SEC requires settlement language saying the accused party neither admits nor denies the allegations. The SEC also requires the settling party “to agree in perpetuity not to take any action or to make or cause to be made any public statement denying, directly or indirectly, any allegation in the complaint or creating the impression that the complaint is without factual basis,” according to the petition. Such a gag does not pass constitutional or legal muster, the NCLA said.
Halia closes a $30M series C to develop inflammasome inhibitors
Halia Therapeutics Inc. has completed a $30 million series C financing to further develop its lead asset, a selective and orally bioavailable first-in-class NLRP3/NEK7 inflammasome inhibitor. The first patient in the phase IIa study of HT-6184 for treating lower-risk myelodysplastic syndromes, a group of cancers created by underdeveloped cells produced by bone marrow, was dosed in December 2023. Halia said the financing is also designed to support IND-enabling studies for other programs, such as developing Leucine-rich repeat kinase 2 inhibitors to treat neurological diseases such as Parkinson's and Alzheimer's diseases. The financing was led by Todd Pedersen and existing investors.
US CMS to negotiate sickle cell gene therapy agreements
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said. Whether that will be a boon or a boondoggle for Bluebird Bio Inc. and Vertex Pharmaceuticals Inc., which both received FDA approval in December for their sickle cell gene therapies, will depend on the terms of outcomes-based agreements CMS negotiates with the manufacturers over the next year.
Celltrion to incubate four biotech startups with Seoul Biohub
Celltrion Inc. has taken under its wing four Korean biotech startups as part of its joint “Open Innovation” program co-run with Seoul Biohub since October 2023, adding to its efforts to grow into a Korean biopharma giant with incubating prowess. Medimabbio Inc., Atheonbio Inc., Enterobiome Inc. and S&K Therapeutics Co. Ltd. were named as the four promising biotechs, selected for innovative technologies across the fields of antibody-based immunotherapy, microbiome and small-molecule compounds – key areas of Celltrion’s new and ongoing research.