Biogen Inc., the largest Massachusetts-based biotech company, is facing challenges to its most important drug in development as well as its top-selling product already on the market.
Biogen will come under intense scrutiny next month when it reports fresh clinical data from an ongoing study of an experimental Alzheimer’s drug pivotal to its future. The Cambridge company is considered a front-runner in the race to develop the first treatment for the disease.
Meanwhile, in patent court hearings scheduled for next week, Biogen will seek to fend off a European rival contesting key intellectual property underpinning Biogen’s popular multiple sclerosis pill, Tecfidera. That drug generated $3.6 billion in sales last year.
The two events are creating an unusual amount of uncertainty for a company that has long been an anchor of the state’s biopharma industry, but is trying to navigate a difficult transition from multiple sclerosis medicines to a broader portfolio of drugs, including the Alzheimer’s treatment.
A Biogen spokesman said no one was available to comment. During a shortened stock trading day Friday, the company’s shares edged down 0.2 percent to $305.17, a loss of 32 cents.
Results from Biogen’s study of its Alzheimer’s drug, called aducanumab, last year showed that it slowed the mental decline of a small number of patients who had early indications and mild cases of the neurodegenerative disorder.
But in a Friday note to investors, Geoffrey Porges, biotech analyst at Boston health care investment bank Leerink Partners, lowered his estimate of Biogen’s probability of success with the experimental drug from 65 percent to 35 percent.
That was due to the disclosure Wednesday by Eli Lilly and Co. that its highly-anticipated Alzheimer’s drug had failed in a larger and later-stage trial, casting doubt on other companies’ research into finding a treatment for the disease.
“Realistically, this has to reduce our confidence in the ‘amyloid hypothesis,’” Porges wrote, referring to the assumption behind Lilly and Biogen’s research that the buildup of protein clumps known as beta amyloid contributes to the development of Alzheimer’s.
He noted, however, that Biogen’s drug is a different antibody that works in a different way on a different set of patients than Lilly’s drug. If the Biogen does succeed against the odds, Porges said, its market share “will certainly be larger” because of Lilly’s failure.
In the patent interference case, Danish-based biotech company Forward Pharma A/S is claiming that Biogen infringed on its patents covering the development of an important ingredient used in the drug, as well as one related to determining the appropriate dosage of Tecfidera. Biogen denies the charges.
A decision against Biogen, not expected until next year at the earliest, could give Forward Pharma a claim on royalties from Tecfidera sales.