Biogen hasn’t had many wins with its failed Alzheimer’s disease drug Aduhelm, but now the company can chalk up a courtroom victory.
This week, a Massachusetts federal judge dismissed an investor lawsuit centered on the company's public communications about Aduhelm.
The investors, led by a group called the Oklahoma Firefighters Pension and Retirement System, sued Biogen and current and former executives last February, alleging that the company made more than two dozen misleading statements during its controversial Aduhelm launch. The statements ranged from assertions about price and Medicare coverage to Biogen’s alleged interactions with the FDA.
But the plaintiffs’ arguments didn't hold up to legal standard, U.S. District Judge William G. Young wrote in an order this week. The judge scratched every group of so-called "misleading" statements, saying that the investors “misconstrued” the company's communications.
“Ultimately fatal to Oklahoma Firefighters’ case is the constant misrepresentation of what the defendants said,” Judge William G. Young wrote in the dismissal.
Biogen filed the motion to dismiss the case in July. In it, the company claimed that the allegations were “generalized statements that are replete with vague adjectives and adverbs and lack the specificity" required by law.
For Biogen, the lawsuit came after a troubled and controversial launch. In December, a scathing congressional report detailed “inappropriate” and “atypical” communications between the company and the FDA before the approval. The report came after an 18-month investigation which revealed collaboration between the company and the agency to push the therapy through the regular process despite uncertainty on safety and efficacy.
Even after the drug reached the market, it failed to secure critical Medicare coverage and never gained steam on the commercial market.
Now with the Aduhelm investor suit off its back, Biogen has more time to focus on its Alzheimer’s disease ambitions with the drug's successor, Leqembi. The Eisai-partnered drug scored an accelerated approval in January, giving the partners another chance to tackle the tough-to-treat disease. With a meticulously planned launch, the drug is set to generate billions in revenues through 2028, analysts with GlobalData Healthcare said this week.