Rheumatoid arthrtitis alert - Sanofi announces full enrollment of key Sarilumab study in rheumatoid arthritis earlier than expected
This alert is an extract from our 100+ slide UpdatesPlus-Rheumatoid Arthritis report due out later today or
tomorrow (now available). This report provides full analysis of key information released in the rheumatoid arthritis arena over the past few months. The report also provides a fully up to data rheumatoid arthritis landscape and clinical trials timeline. For further information please contact fiona.watts@leaddiscovery.co.uk
Related article: EULAR 2014 - Further positive Phase 3 data were reported yesterday for Sanofi/Regeneron's sarilumab
Comments: We believe that the Sarilumab data package may be a little patchy at launch. The rheumatoid arthritis market for biologics is currently fragmented into monotherapy, MTX-IR and TNF-IR. Increasingly, early RA is proving an attractive cohort.
Roche has been aggressively positioning (Ro)Actemra around monotherapy efficacy supporting use in MTX-unable patients. Sanofi's SARIL-RA-ONE is expected to complete in time for filing supporting monotherapy. Disappointingly however, SARIL-RA-ONE is focusing on immunogenicity rather than also evaluating efficacy. This will limit competitiveness in the monotherapy setting. MOBILITY is in MTX-IR patients and may therefore support use as a 1st line biologic. The study is however placebo controlled, and comparative data supporting 1st line (MTX-IR) biologic use will be limited.
Sanofi's clinical program seems most directed towards TNF-IR patients. ASCERTAIN is comparing Sarilumab and (Ro)Actemra in this cohort but this is a safety study. Unless important differences are revealed, Sanofi may have difficulty competing with (Ro)Actemra. TARGET and COMPARE are probably more important commercially, and especially COMPARE which will allow Sarilumab to compete with Enbrel as a 2nd line biologic. Early completion of COMPARE is therefore important. Sanofi's targeting of TNF-IR patients is not too surprising for a new molecule, and indeed this strategy may allow higher pricing. If approved Sanofi may then choose to rapidly follow up with further studies comparing Sarilumab with (Ro)Actemra, especially if SARIL-ONE reports particularly low immunogenicity, or if ASCERTAIN suggests improved safety vs (Ro)Actemra
Stop press: Since the above blog was written it seems that although COMPARE is now listed as "ongoing, but not recruiting participants" on clinicaltrials.gov, Sanofi may not have followed convention in updating this entry. Usually this statement infers that the target patient number has been reached. In contrast if a study has been stopped early for commercial reason, slow enrollment, adverse events etc, then this would be specified. The situation regarding this trial is fluid and the above analysis will be updated if anything changes
- Sanofi/Regeneron intends to file IL-6R mAb Sarilumab for rheumatoid arthritis in 2015
- Registration will be supported by MOBILITY in MTX-IRs. TARGET
and COMPARE will provide efficacy data in TNF-IR patients
- Commercially, COMPARE is possibly more important than TARGET as it is comparing Sarilumab and Enbrel in Humira-IRs
- Initially COMPARE was expected to read out after registration but Sanofi has now announced full enrollment likely allowing it to support registration
Comments: We believe that the Sarilumab data package may be a little patchy at launch. The rheumatoid arthritis market for biologics is currently fragmented into monotherapy, MTX-IR and TNF-IR. Increasingly, early RA is proving an attractive cohort.
Roche has been aggressively positioning (Ro)Actemra around monotherapy efficacy supporting use in MTX-unable patients. Sanofi's SARIL-RA-ONE is expected to complete in time for filing supporting monotherapy. Disappointingly however, SARIL-RA-ONE is focusing on immunogenicity rather than also evaluating efficacy. This will limit competitiveness in the monotherapy setting. MOBILITY is in MTX-IR patients and may therefore support use as a 1st line biologic. The study is however placebo controlled, and comparative data supporting 1st line (MTX-IR) biologic use will be limited.
Sanofi's clinical program seems most directed towards TNF-IR patients. ASCERTAIN is comparing Sarilumab and (Ro)Actemra in this cohort but this is a safety study. Unless important differences are revealed, Sanofi may have difficulty competing with (Ro)Actemra. TARGET and COMPARE are probably more important commercially, and especially COMPARE which will allow Sarilumab to compete with Enbrel as a 2nd line biologic. Early completion of COMPARE is therefore important. Sanofi's targeting of TNF-IR patients is not too surprising for a new molecule, and indeed this strategy may allow higher pricing. If approved Sanofi may then choose to rapidly follow up with further studies comparing Sarilumab with (Ro)Actemra, especially if SARIL-ONE reports particularly low immunogenicity, or if ASCERTAIN suggests improved safety vs (Ro)Actemra
Stop press: Since the above blog was written it seems that although COMPARE is now listed as "ongoing, but not recruiting participants" on clinicaltrials.gov, Sanofi may not have followed convention in updating this entry. Usually this statement infers that the target patient number has been reached. In contrast if a study has been stopped early for commercial reason, slow enrollment, adverse events etc, then this would be specified. The situation regarding this trial is fluid and the above analysis will be updated if anything changes
posted by Jon Goldhill at 12:23 PM
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