UpdatesPlus-Psoriasis (July 31st) - Analysis of breaking research and development in psoriasis

We are pleased to announced the most recent issue of UpdatesPlus-Psoriasis.  This regular analysis provides in depth information on all key recent events in the area.  To receive further information or instruction on how to access the full report please contact fiona.watts@leaddiscovery.co.uk

This issue includes analysis of the following:

The biologic market: Sales for biologics approved for psoriasis continue to expand across all indications.  Q2 sales were $8.6B, an 18% increase over Q2 2013.  Of this we estimate that sales for psoriasis were $2B.  Stelara sales continue to accelerate dramatically.  Amgen has indicated that Enbrel sales are being threatened as a result and that new DTC activity will be initiated to counter this threat.  Biosimilar threat is also growing with Sandoz and Coherus both advancing candidates supported specifically by psoriasis data. A further interesting advance is the clinical development of sub-dermal etanercept by ASIS.  

Humira sales have also grown, but like other biologics, biosimilar threat is growing with Amgen completing enrollment of a Phase 3 ABP 501 study.  Recruitment to a Phase 3 PsO study has completed.  Amgen has previously indicated that its biosimilars will launch from 2017 onwards. Infliximab is the only biosimilar launched for psoriasis and roll out continues with the most recent approvals being in Turkey and Japan

IL-17s:  This novel class continues to move forward with EMA and FDA opinion on secukinumab expected Q4 2014/Q1 2015. CLEAR (H2H vs Stelara) is fully enrolled and on track to read out in 2015.  Positive data will have important pricing and launch implications. Following the read out of top line brodalumab data from AMAGINE-1, Amgen has confirmed AMAGINE-2/3 (vs Stelara) will read out in Q4.  We presume that filing will be Q2 2015, just before that of Lilly's Ixekizumab

Other biologics: UCB and Dermira have announced a collaboration on the development of Cimzia for psoriasis.  Earlier in the pipeline, GSK has taken first in class LAG-3 candidate into the clinic

Methotrexate:  Competition for sc MTX formulations has increased with the approval of Medac's Rasuvo. This follows earlier approval of Antares' Otrexup which has been launched in the dermatology space by Leo

Small molecules:  Celgene has confirmed that Otezla is on track for EU/US launch around the end of 2014.  Pfizer's Tofacitinib is also approaching the market following positive data from OPT Pivotal #1 and #2.  We expect filing in the US early 2015, at around the same time as an sNDA for Pfizer's qd formulation.  We speculate positive psoriasis data may also trigger a combined filing in the EU for psoriasis and RA.  Pfizer is also developing PF-06263276, a broad spectrum JAK/TYK2 inhibitor. Pfizer has opened a patient study which, interestingly compares this candidate to topical tofacitinib and daivonex

Other candidates we report on in the present issue include GSK/Galapagos' JAK inhibitor GSK2586184; Can-Fite' adenosine receptor modulator, CF101 and a novel candidate being developed by Kadmon.  Finally, Xenoport is developing a novel fumarate prodrug

Steroids and Vitamin D derivatives:   As competition grows for share of the pediatric market, Leo has reported full results on one of its large Phase 3 pediatric studies of Taclonex,. Galderma has also opened a Phase 4 pediatric study of calcitriol ointment, Silkis/Vectical. In contrast to the Leo study of 12-18 year olds, Galderma's trial is enrolling 2-12 year olds

To receive further information or instruction on how to access the full report please contact fiona.watts@leaddiscovery.co.uk