During a conference call with investors, Biogen Inc. officials defended the price of Aduhelm (aducanumab) for Alzheimer’s disease (AD), with CEO Michel Vounatsos saying the $56,000 per year price tag was based on “the value it is expected to bring to patients, caregivers, and society.”
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
LONDON – In a sizeable seed round for a U.K. biotech, Transine Therapeutics Ltd. has raised £9.1 million (US$12.9 million) to take forward a novel method for up-regulating endogenous protein production using a naturally occurring class of long noncoding RNAs.
Public biopharmaceutical companies did manage to attract some investors off the sidelines in May with medical conference season getting into full gear. However, it was generally another lackluster month, with the Nasdaq Biotech index dropping 2% in the period in contrast to the broader markets with the Dow Jones Industrial Average growing by 2%. The sector, however, could get a significant boost in the next few days if the FDA gives the green light to Biogen Inc. and Eisai Co. Ltd.’s experimental Alzheimer’s disease therapy, aducanumab, a recombinant chimeric human IgG1 monoclonal antibody targeting beta-amyloid, that could be the first disease-modifying therapy for an indication that has seen no novel therapies approved in more than 15 years.
Single-cell gene studies at Duke-NUS Medical School in Singapore and Monash University in Melbourne, Australia, have shown that gene expression signatures underlie the microglial phagocytosis of beta-amyloid (Abeta) plaque in patients with Alzheimer's disease (AD), the authors reported in the May 20, 2021, edition of Nature Communications.
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.
While it remains to be seen whether the FDA will break with its advisory panel and approve Biogen Inc.’s high-profile Alzheimer’s candidate by the June 7 PDUFA date, the clinical data for beta-amyloid-targeting aducanumab didn’t exactly impress experts at the Institute for Clinical and Economic Review, who suggested an annual price tag of $2,560 to $8,290.
An international collaborative study led by scientists at Sweden’s Lund University has classified Alzheimer’s disease into four distinct subtypes, which has important implications for the management of the progressive neurodegenerative disease, the authors reported in the April 29, 2021, edition of Nature Medicine.
Biovie Inc. Chairman Terren Peizer said Neurmedix Inc. “had been offered a better deal in the shorter term,” but the contract signed by the two firms – which installs entrepreneur Cuong Do the new CEO of Biovie, replacing Peizer – made more sense to both parties. Santa Monica, Calif.-based Biovie is taking over the assets of Neurmedix Inc., of San Diego, bringing aboard phase III-ready NE-3107, an oral small-molecule therapy designed to inhibit insulin resistance in Alzheimer’s disease (AD).