Is it too late for Biogen?

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. But is it too late for Biogen to stage a comeback with their reputation damaged?

Biogen executives vowed to fight hard to reverse Medicare’s preliminary decision to sharply limit coverage of the company’s Alzheimer’s drug while saying more cost cuts and strategic measures are possible if the decision stands. Never mind that physicians have turned against the drug Biogen wants to fight the decision because of their business needs.

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. The critics have also expressed concerns about whether the drug’s benefits, which appeared to be modest in studies, are worth the risks of side effects such as brain bleeding that require regular physician monitoring. Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.”

A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast. Around 2 million Americans could be prescribed aducanumab, at an estimated cost of $20,000 to $50,000 per person per year. Biogen claims the benefits of slowing declines in cognition and day-to-day function are worth this price. I think the company is wrong, and I agree with the Institute for Clinical and Economic Review; the data to make this case are murky and, even if they were clear, the drug’s benefits are ambiguous at best and not worth this cost. Putting it on the market will stress Medicare’s resources.”

I had a chance over the last three months to talk to many of HCPs. Some are not allowing Biogen reps in their office others say Biogen’s reputation is in the toilet. Now Biogen wants to partner with Roche to develop a cancer drug? The question that has to be asked is how will physicians respond to this drug if approved?

I believe Biogen is starting from square one and will have to do a lot to earn back the trust of physicians.