Replies to post #174009 on Biotech Values

[DewDiligence]

Did anyone else notice Craig Wheeler’s CC slip-up vis-à-vis M923/Humira? I thought the observation in #msg-97084466 would generate some discussion and possibly even some controversy.

[GrthzGd]

It's a bit confusing. Is this the MNTA exchange that you're referring to?

Ronny Gal - Bernstein
Got you. I am just noticing the Advair guidance [I think referring to M923] asked for PD trial using FEV1 as an endpoint to measure PD, and I was wondering if this is just not an equivalent of a confirmatory PD trial to have an MRI endpoint if not an efficacy endpoint?

Craig Wheeler
Well, you have to validate the endpoint right. So is that MRI effectively tied to clinical outcomes? In FEV, it’s often tied pretty directly to disease progression. So you’d have to make that leap to be able to think about it same way.

Advair is approved for COPD (Chronic Obstructive Pulmonary Disease, or asthma), which would also be consistent with the FEV1 (Forced Expiratory Volume) test reference.

On the other hand, CW adopted Ritu Baral's mention of M923's reference molecule as being "approved for multiple indications." Advair appears to be indicated only for asthma, whereas Humira does have multiple indications, as follows:

3.1 Rheumatoid arthritis
3.2 Psoriatic arthritis
3.3 Ankylosing spondylitis
3.4 Crohn’s disease
3.5 Ulcerative colitis
3.6 Plaque psoriasis
3.7 Juvenile idiopathic arthritis

(Interestingly, ABBV has strategically invested in one of my private portfolio companies because their device would deliver Humira directly to the colon.)

I note also that Advair and Humira could both fit the following:

Our lead program M923, a biosimilar in the autoimmune inflammatory space is our most advanced biosimilar product.