UpdatesPlus - Rheumatoid Arthritis August research and development issue now available

The August issue of UpdatesPlus - Rheumatoid Arthritis is now available, offering a top to bottom analysis of research and development activity from the rheumatoid arthritis arena.  This 100 slide issue provides analysis of commercial/life cycle management activity around the biologics all the way down through recent launches such as Xeljanz, late clinical candidates such as sarilumab and preclinical proof of concept data on new targets such as HDAC.  We also provide a full analysis of biosimilar activity as it relates to rheumatoid arthritis

To receive the full report please contact fiona.watts@leaddiscovery.co.uk

Analysis included in this issue includes:

• A look at Q2 2014 sales of the biologics which we estimate to have reached $4.7B for rheumatoid arthritis and $9.6B across all indications.  We look at regulatory activity including EU approval of RoActemra sc and monotherapy, as well as well as J&J's decision to withdrawn its MAA for iv Simponi.  With regards to life cycle management, data have been presented on early rheumatoid arthritis as stakeholders battle for this segment.  We analyze new data from key studies such as PRIZE and AVERT
• Xeljanz is one of the highest profile recent launches.  In the early stages of its roll out we look at new analysis of key studies such as ORAL START and new studies including ORAL STRATEGY
• As the sale of current biologics continues to grow so to do biosimilars advance.  We analyze recent activity including the important news that Celltrion has filed Remsima in the US.  Four other biosimilars have also entered Phase 3 for rheumatoid arthritis over recent weeks
• We also analyze news around the development of the new IL-6 biologics.  Most activity exists around sarilumab as Sanofi approaches its targeted launch in 2015.  As hinted in our blogs earlier this week we understand that although development proceeds well, a key study may have been stopped.  New data have also been released on IL-6 receptor antibodies, sirukumab and clazakizumab.  Efficacy looks good and we analyze this data
• With regards to other mechanisms of action, much has happened over past weeks. Three of four Phase 3 baricitinib studies are now fully enrolled with data expected between Sept 2014 and  Feb 2015.  A fourth, RA-BEAM is still enrolling as Lilly prepares to launch in the US, EU and Japan simultaneously in 2016.  Earlier in development Novartis' NURTURE 1 study of secukinumab is now fully enrolled. 24wk endpoints should be reached by the end of 2014, providing important proof of concept data in the IL-17 field.  AstraZeneca has announced promising data on its GM-CSF candidate, Mavrilimumab with Phase 3 decisions expected in 2015
• As usual we also trawl preclinical data, looking for possible areas of future development.  This month we have identified data suggesting IL-17 blockade may limit breast cancer metastasis.  This may be particularly interesting if NURTURE 1 establishes proof of concept for IL-17 mAbs as anti-inflammatories in the rheumatoid arthritis setting.  We also describe convincing new preclinical data establishing HDAC6 as a therapeutic target and med chem activity from Abbvie describing new PKCθ inhibitors

This is just a small look at what this issue of UpdatesPlus Rheumatoid Arthritis is looking at. We believe that we have covered all key information released in the area over the past few weeks.  Our formula is simple - for the past 8 years our researchers continuously monitor company websites and presentations, trial data bases and journal articles and use their expertise to provide analysis in one easy to read slide deck.  To receive the full report please contact fiona.watts@leaddiscovery.co.uk