There stay appreciable doubts about whether or not the FDA will approve aducanumab. Phase 3 trials of the anti-amyloid antibody have been stopped for futility in March 2019, solely for Biogen to resurrect the remedy seven months later after going over the expanded dataset. The FDA is because of decide by June 7 this 12 months.
However, even analysts who query whether or not the present information assist the efficacy of aducanumab assume there’s a main industrial opportunity for the drug if it wins approval.
Biogen CEO, Michel Vounatsos, started to quantify simply how huge the opportunity may very well be at a latest investor occasion.
“The market is extraordinarily giant. Based on the entry standards of our Phase 3 research, it’s greater than 10 million sufferers in the US solely. Obviously, it doesn’t imply that every one the sufferers qualify. It doesn’t imply that every one the sufferers are recognized from the healthcare system. Some of them are usually not recognized. So the epidemiology is completely great. It’s a multi-billion-dollar opportunity,” Vounatsos mentioned.
Exactly how huge the industrial opportunity is will rely in half on the value Biogen units. External estimates of the doubtless value have hovered across the US$50,000 mark. Biogen now has a value in place, Vounatsos mentioned, however is but to reveal it publicly.
Vounatsos has mentioned the evaluation Biogen carried out to calculate the worth of aducanumab. The evaluation of the burden Alzheimer’s place on society, which places direct and oblique prices in the US at greater than US$850bm, suggests Biogen may take into account a reasonably excessive value for aducanumab.
“We know that 75% of the sufferers affected on the age of 80 must be institutionalized. And it prices greater than US$100,000 a 12 months to maintain these sufferers in establishments, in addition to the emotional influence it has on the caregivers, on the household. So it’s a societal challenge and these are key concerns in order to evaluate the worth,” Vounatsos mentioned.
Biogen is investing in anticipation of the drug coming to market, establishing a cross-functional group to arrange websites to deal with sufferers and gearing as much as ship merchandise from websites in North Carolina and, later, Switzerland.
Elements of a profitable launch will likely be past Biogen’s direct management. Notably, the necessity to examine if a affected person has mind amyloid would require PET scans or different exams, reminiscent of spinal fluid diagnostics or the blood-based prospects now in growth.
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