Biotech investors had every reason to feel bullish heading into the new decade. The sector had turned around in 2019 and was riding a wave of a very strong fourth-quarter performance, with the BioWorld Biopharmaceutical Index closing up 14% for the year after being underwater from April through to September. Unfortunately, those great expectations were quickly erased during J.P. Morgan Healthcare conference week (Jan. 10 – Jan. 17), which turned out to be a very low-key affair absent of any blockbuster M&A revelations. As a result, confidence has now given way to concerns about the prospects for biopharmaceutical companies going forward, particularly as unfavorable political rhetoric on drug pricing will certainly be dialed up during this election year.
Pfizer Inc. was a swinging door today as it sold its small molecule for treating patients with behavioral and neurological symptoms to Biogen Inc., while licensing reboxetine’s data and intellectual property and granting esreboxetine’s development and commercialization rights to Axsome Therapeutics Inc.
After dropping to its lowest valuation at the end of September, the BioWorld Neurological Diseases index, a price-weighted index of public biopharmaceutical companies that are focused on developing therapies to treat neurological diseases, got on a roll and climbed 22% during the next two months. However, a surprising trial failure reported by Sage Therapeutics Inc. last week served to eat into those index gains.
SAN DIEGO – Following up on its October announcement that it would file for FDA approval of beta-amyloid-targeting aducanumab, Biogen Inc. presented the final dataset for the phase III Emerge and Engage studies at the 12th Clinical Trials on Alzheimer’s Disease Meeting.
It appears that the spirit of giving has come early, with leading biopharmaceutical companies providing investors with a surprise present of a significant jump in their share prices in October. The reversal in the sector's fortunes was catalyzed by an outpouring of positive news, including strong third-quarter financial results that has spilled over into early November.
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. will get $100 million in up-front payments in a commercialization deal for two of its biosimilar candidates with U.S. company Biogen Inc. Under the deal, Samsung Bioepis will also be eligible for up to $270 million in milestone and option payments, as well as a share of sales revenue.
FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product.
SAN FRANCISCO – Investor sentiment around Biogen Inc.'s plan to soon seek approval for aducanumab in Alzheimer's disease yielded a clear bold reaction in its rising share price Tuesday. But a more nuanced reading was floated during a CNS panel at the BIO Investor Forum the day after, where a focus on new modalities and a call for open-mindedness carried the conversation. "It almost doesn't matter what investors think," said Ellen Lubman, a panelist and chief business officer of Impel Neuropharma Inc. "The reality is that if truly there's a percentage of people getting a benefit from the drug... that's the reason we're all in this business."
Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move.
What the phase III multiple sclerosis (MS) win scored by Biogen Inc. and partner Alkermes plc might mean in the marketplace for diroximel fumarate – tested against their approved MS therapy Tecfidera (dimethyl fumarate) – became fodder for speculation as investors weighed the fine points of side-effect profiles and would-be reimbursement hitches.
