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Msg  2982 of 2987  at  6/20/2020 1:17:29 PM  by

agrossfarm


 In response to msg 2980 by  Workinprogress
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Re: Lupus nephritis

I had never heard of AUPH before (thanks for bringing it up). Lupus nephritis has no role in why I own Omeros (which I would guess is similar to most other OMER investors). 
 
But I gave the company a quick look. 
I note the company has no approved products (or revenue) and 1 drug candidate (voclosporin, an immunosuppressant analog of ciclosporin)  with an NDA filed for one of 2 clinical-stage indications. A 2010 NDA with this drug candidate for uveitis by Lux Biosci got a 'complete response', making me wonder about how much foundational patent life is left. The company claims until 2027 (not long) with subsidiary patents/mechanisms to extend that (pending successful marketing, which likely will lead to challenges).
 
Voclosporin was given fast track but informed by the FDA that it wasn't getting BTD in 2016, even though there was no approved drug for the indication. Roche's lupus drug Gazyva was given BTD in 2019, but this drug (as most immunosuppressants) can kill the patient (& only completed Phase2). I am not familiar with voclosporin's risks, although I know narso won't kill patients and inhibits only the lectin pathway of complement. 
 
I don't recall the Phase 2 lupus data for narso and the N & endpoints probably don't allow a valid comparison to Phase 3 voclosporin data (but if you have done a comparison, please post it). I'd guess that's not a problem for most OMER investors currently focused HSCT-TMA and IgAN. 
AUPH burned much more cash than OMER (AUPH ~$82 million in the last year) but holds a couple years of cash and has just filed a new registration for $500M more.
 
For those of us not focused on lupus, any attraction to AUPH would be because it was potentially be very profitable if their drug is approved. I am wondering about their plans, how fast they can penetrate the market and what kind of cash flow AUPH if/when their NDA is approved (& why they are preparing to sell more stock with ~$190 million cash at the end of Q1).
 
So, please fill us in. 
 
 
 
 


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Msg # Subject Author Recs Date Posted
2983 Re: Lupus nephritis Workinprogress 8 6/21/2020 1:43:35 PM






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