Specialist
Case Distinguished University Chair at Augusta University
Agenda
- Key trends and developments relating to the depression market, focusing on the Biogen-Sage (NASDAQ: BIIB) (NASDAQ: SAGE) collaboration and competitors
- Biogen-Sage’s zuranolone data and potential to treat depressive episodes in the short term
- Placebo effect issues in the depression market
- Psychedelics and other cutting-edge therapeutics
- Real-world data vs clinical trials
- H2 2021 outlook
Questions
1.
Could you start by highlighting the patient population for depressive disorders and sizing the market?
2.
What is the standard of care for depression? Have there been any significant shifts in the last year or so?
3.
It’s my understanding that ketamine delivers outstanding results for patients with depression but government roadblocks make it unaffordable, with sentiment that more research is needed before ketamine can become a viable depression option. What is your take on this matter, and how do you expect it to evolve?
4.
What patient profile would be prescribed or given ketamine?
5.
What percentage of patients are diagnosed with treatment-resistant depression, and how would you define it? To my knowledge, the definition tends to differ across doctors.
6.
One area of debate in this field is the placebo effect and how to draw better efficacy conclusions with depression trials. Where do you stand in this discussion, and how much of a limitation do you believe this is?
7.
What is your mechanistic assessment of Biogen and Sage Therapeutics’ episodic therapy, zuranolone?
8.
How would you say zuranolone compares to the other MoAs [mechanisms of action] out there? What are its main advantages or disadvantages?
9.
How might zuranolone’s uptake and prescription volumes trend if approved, given it demonstrated rapid antidepressant effects and one of the largest unmet needs in the segment is faster onset of effects?
10.
Do you think zuranolone’s short-course nature will hinder uptake to any extent?
11.
What percentage of patients do you think would get zuranolone if approved?
12.
What drugs would zuranolone be displacing or replacing, if any?
13.
If approved, how do you think zuranolone and Zulresso – also known as brexanolone or allopregnanolone – would compete for market share? Essentially, why might zuranolone be better than Zulresso?
14.
Zuranolone proved to be safe and effective in reducing symptoms of post-partum depression in a phase 3 clinical trial, and it has the potential to be the first oral rapid-acting option for patients. How exciting is this in this indication?
15.
How should we frame zuranolone’s overall market opportunity across the depressive indications it’s targeting? Which hold the most promise, whether due to an unmet need or any other defining factors?
16.
Could you quantify zuranolone’s potential reach in the treatment-resistant depression field?
17.
There are questions around whether the FDA’s recent, controversial approval of Biogen’s Aduhelm will signal benefits for other widespread disease areas with high unmet needs, or represent a new beginning of more regulatory challenges. How might this situation impact an indication such as depression?
18.
What are the key pricing or reimbursement dynamics for zuranolone or the broader depression treatment market?
19.
Are there any other players in development that could be disruptive?
20.
What is your overall assessment of TMS [transcranial magnetic stimulation] and providers such as BrainsWay or Neuronetics? How does the treatment compare to electroconvulsive therapy?
21.
How would you expect the overall strategy of treating depression to shift, particularly for newer compounds in the pipeline?
22.
Are there any key topics we’ve yet to discuss that you’d like to highlight in conclusion?
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