From Barrons re MS:
"Credit Suisse
The European Committee for Treatment and Research in Multiple Sclerosis meeting will not include pivotal data presentation for any of the next-generation multiple-sclerosis agents.
It will, nevertheless, be an important forum providing: 1) incremental clinical data for all agents as described below; 2) premarket messaging, in particular for Sanofi's (ticker: SNY) (technically Genzyme's) Aubagio (approved Sept. 12) and Alemtuzumab (Prescription Drug User Fee Act (PDUFA) date set for second-quarter 2013) and Biogen Idec's (BIIB) BG-12 (PDUFA date set for Dec. 28); and 3) we also flag S1P1 modulators as potential game changers from the meeting with clinical data from three second-generation S1P1 compounds providing more color on the hypothesis that its dosing/pharmacokinetic profile may mitigate the class's cardiovascular (CV) issues (versus S1P1/3 specifically).
With the granularity of DEFINE and CONFIRM trials already positioning BG-12 as the leading neuroimmunomodulating (NIMO) agent, at European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), we will be focused on: 1) Integrated analysis of DEFINE and CONFIRM. Abstracts will provide additional support of BG-12's claims on efficacy, particularly in reducing disability progression.
Aubagio was approved in the U.S. on Sept. 12, so the launch fanfare could be interesting. Incremental TOWER data show Aubagio barely hit statistical significance in reducing 12-week Expanded Disability Status Scale (EDSS) progression by 32% relative to placebo. Additional analyses of CARE-MS II data show Alemtuzumab was more effective in reducing annualized relapse rate (ARR) in interferon-beta prior users. Concerns of immune-related safety issues remain.
The abstract for Actelion's [of Switzerland] Ponesimod was somewhat validated comments made by Actelion management post the top-line PIIb data readout (Aug 2011): "…our data (are) outstanding…and in terms of the relapse rate…at the top range of anything which has been ever seen with an oral drug." The six-month ARR reduction was 52% (versus placebo). However, we note the lack of granularity in the abstract on CV issues especially bradycardia. Data from Merck KgaA's [of Germany] ONO-4641, Novartis' (NVS) BAF312, and Receptos' [closely held] RPC1063 were also provided. ONO-4641 showed high efficacy (six-month ARR reduction of 70%), but also caused atrioventricular (AV) block and bradycardia. BAF312 showed reductions in mean CUAL (combo measurement of gadolinium-enhancing, T1 and T2 lesions). Data on RPC1063 suggest fast lymphocyte recovery. However, CV issues (bradycardia, heart rate reduction, AV block) were observed.
Focus on Copaxone by Teva Pharmaceutical Industries (TEVA) will be on the Phase III GALA trial that evaluated three times weekly dosing in the late breaker session on Oct. 13."
AI
