- Eisai and Biogen posted promising data for BAN2401 that lifted its stock and had the pharma trade publications talking breakthrough.
- But there is a lot of controversy swirling around the study.
- It seems that Biogen may have moved the goal posts to gain more favorable data endpoints.
- It’s not about patients, it’s about the stock price and getting investors on board.
BAN240, Biogen’s Alzheimer’s drug candidate, produced positive data in a mid-stage study with a statistically significant 30% slowing in the rate of decline compared to the placebo arm in the high dose arm of the study at 18 months. But the data comes with a huge asterisk.
According to Endpoint News “critics quickly began pulling apart the data, finding enough holes in it to squelch Biogen’s share price , which plunged 12%. Eisai would quickly follow with its own drubbing after questions were raised in a call with Biogen execs about a decision by European regulators to move APOe4 carriers out of the high dose arm as they were worried by the threat of brain swelling — or ARIA-E — which they are prone to. APOe4 carriers are at higher risk of the disease as well as faster progression, and putting them in lower dose arms — while leaving APOe4 patients in the placebo group — raised the possibility that the researchers had made it possible for the high dose arm to hit statistical significance. Otherwise, it could have all been just another failure”.
What does all this mean? It means that Biogen’s effort to generate buzz and Wall Street interest has backfired and backfired big-time . The data has more holes than swiss cheese and while the media talks about “potential breakthrough”. As The Wall Street Journal points out, a press release from Biogen did not disclose crucial details.
We all want a potential breakthrough when it comes to treating Alzheimers, but Biogen’s sloppy approach is not the way to do it. It’s easy to get excited about initial trial results, but our job is to temper those results with questions to ensure we are on the right track. All this news has done is left Biogen with a lot of pie on their faces.
Originally published at worldofdtcmarketing.com on July 27, 2018.