Tuesday, 10 September 2013

Revolution over Evolution: ECTRIMS 2013

Credit Suisse report: Revolution over Evolution. #MSBlog #MSResearch

"I was sent this link last night. You may find it interesting. If I can criticise the headline results is that it makes no allowance for a black swan. I think the MS paradigm is ripe for a shift. What do you think?"

"What this report does tell you is what a marketing jamboree ECTRIMS has become; it has been like for years. But then most medical conferences are like this. What will be of interest is the science out on the floor in the poster sessions. I wonder how many posters will address the infectious hypothesis of MS?"

It's a Revolution! - But Just How Big??

Summary: In our view, it's not a question of whether it is a revolution or evolution anymore; the MS market IS undergoing a revolution! The question is now just how big a revolution (and for investors what is not priced into the stocks!). This revolution in the clinical management of MS is being driven not only by the launch of next-gen agents but also by changing treatment and diagnosis paradigms. The consequence of this revolution is that MS is rapidly changing from a “diagnose, treat, and see” to a “treat aggressively to the goal” therapeutic area. The upcoming ECTRIMS meeting (Copenhagen Oct 2-5), will deliver incremental clinical data (rather than key pivotal data) for next-gen MS agents. More importantly, the meeting will act as an important “front-line forum” to gauge the massively changing dynamics within the MS therapeutic area. We will be attending this conference. Within this note, we provide an itinerary planner for the meeting for institutional investors.

Notable incremental data on next-gen agents (Exhibit 40 - Exhibit 66) to be looking for at ECTRIMS are: Tecfidera (BIIB): 3-year, follow-up integrated (efficacy inc MRI) data from DEFINE, CONFIRM, and ENDORSE. A long-term, interim update on safety from the ENDORSE study. Plegridy (BIIB): Further efficacy and safety analyses of ADVANCE data will be presented. Aubagio/ Lemtrada (Sanofi): Pooled efficacy and safety PIII data/3-year disability, safety data + lymphocyte dynamics in CARE-MS II data. Laquinimod (TEVA/Active Biotech): PIII CONCERTO trial design for 0.6mg and 1.0mg doses. Gilenya (Novartis/Mitsubishi): Long-term efficacy FREEDOMS II data. Selective S1P1s: RPC1063 (RCPT): Focus will be on PI and QT/QTc data. Ponesimod (ATLN), ONO-4641 (Ono/Merck KgaA): Additional PII data will be presented. Siponimod (Novartis): PI QT/QTc data on "placebo-like" AV effects will be of interest. Ocrelizumab (BIIB/Roche)/Daclizumab (BIIB/ABBV). No major new data, but Roche is hosting a whole symposium devoted to B-cell therapy.

Our top-10 sound bites/observation/questions/focal points for the conference are below – We will be publishing more details on these topics ahead of the conference: 

(1) “Warehoused” untreated MS population remains an important sensitivity. 
(2) Earlier and “treat-to-goal” like management to drive a dynamic market. 
(3) Increasing focus on MRI clinical measures in diagnosis and treatment. 
(4) Is our “three buckets hypothesis” still valid? 
(5) Is price of drugs influencing treatment choices? 
(6) What is interesting in the earlier stage development pipeline? 
(7) How do physicians view the relative clinical efficacy of MS therapeutics? 
(8) How will the treatment sequencing change? 
(9) What is the emerging side effect profile of Tecfidera? (especially (a) Is PML a real gating point concern?; (b) What is the real world flush/GI impact?) 
(10) How do physicians view Tecfidera leukocyte and lymphocyte monitoring?

As a final humorous point/observation, we find the title of the two Biogen sponsored symposium to be held at ECTRIMS very interesting: 10/2 "Biogen Idec: Reinventing MS care – Evolution"; 10/3 "Biogen Idec: Reinventing MS care – Revolution". Smart titles (in our view).

Credit Suisse Document Link (60 Pages, 847KB)

06 Sep 2013
Have we got the autoimmune paradigm of MS wrong? #MSBlog #MSResearch “I was involved in a heated discussion yesterday at a meeting in Germany that centred on the current, and future, DMT market for MS. The opinion ...

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