Specialist
Senior executive at Todos Medical Ltd
Agenda
- The FDA's 7 June decision on Biogen's (NASDAQ: BIIB) Aduhelm (aducanumab) for Alzheimer's – potential uptake and impact on broader market, focusing on Roche's (VTX: ROG) gantenerumab
- Roche's gantenerumab – MoA (mechanism of action) and sources of differentiation vs other amyloid beta-targeting therapies and trial readouts
- Gantenerumab's lowering of biomarkers in inherited Alzheimer's and potential impact on symptoms
- Outlook, highlighting potential for pricing reform
Questions
1.
What is your take on the FDA’s approval of Biogen’s new treatment for Alzheimer’s disease, Aduhelm [aducanumab]? Some doctors and scientists believe there was insufficient evidence to support the decision. Do you think the approval was warranted?
2.
Do you expect Aduhelm to have a true clinical benefit?
3.
How should we interpret surveys that suggest many physicians would not prescribe Aduhelm? Have recent surveys been in line with your expectations?
4.
A specialist in a previous Interview estimated that about 10-15% of patients will receive Aduhelm [see Alzheimer’s Disease – Biogen’s Aducanumab & Eli Lilly’s Donanemab – 9 June 2021]. Could you outline the factors likely to drive uptake? Do you expect patient excitement or physician recommendation to drive demand?
5.
What percentage of Aduhelm’s potentially huge patient population could receive the drug in the near-to mid-term? Would you say the estimate of 10-15% is realistic?
6.
What treatments do you think Aduhelm will displace in patients that receive it?
7.
What implications do you think Aduhelm’s approval will have on federal healthcare programmes, especially considering the drug’s clinical benefit is still in question?
8.
Could Aduhelm’s approval significantly impact drug price reform in the US, as some talks suggest?
9.
Do you think patient advocacy groups will have sway over the payers, given the level of unmet need?
10.
How do you interpret the amyloid hypothesis and its role in Alzheimer’s? Aduhelm’s approval has revived a focus on this theory.
11.
How do you assess Roche’s gantenerumab? How is it differentiated vs aducanumab or other amyloid-beta targeting approaches?
12.
Are there any red flags or areas of hesitation that you would highlight around gantenerumab?
13.
Do you think gantenerumab’s phase 3 dose and the removal of amyloid-beta plaque will be enough to win Roche an accelerated approval?
14.
Do you think Biogen’s Aduhelm approval sets a lower bar for a player such as Roche to cross the finish line with gantenerumab? How might this play out given the controversy we discussed? Do you think Roche will be held to a higher standard than Biogen?
15.
When do you think gantenerumab could be on the market?
16.
What competitive threat would gantenerumab pose to aducanumab on prescription volumes or value, especially considering its more convenient subcutaneous dosing?
17.
Is there anything else relating to Roche, Biogen or the broader Alzheimer’s disease treatment market that is important to highlight?
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