Summary

Sociable Pharma’s ‘Treatment Landscape’ contains evaluations of ongoing development activities within the Rheumatoid Arthritis (RA) market, analysis of current & potential future product positioning, and forecast approval dates (by quarter) for candidates in Phase II development, or higher -
- Executive Summary: Contains analysis of key market events that have occurred during the previous month and which have impacted Sociable Pharma’s view of the disease landscape
- Landscape Updates: ‘Order of Entry’ analysis, detailing timeline forecasts for each drug in Phase II development or higher; Timeline forecasts for each approved product’s lifecycle management initiatives; ‘Market Entry’ & ‘Direction of Travel’ positioning analysis for pipeline & currently approved therapies
- Pipeline Landscape: An overview of pipeline candidates, containing snapshots of current development status; Expected drug-specific events & milestones until YE 2019
- Approved Product Landscape: An overview of pipeline candidates, containing snapshots of current development status; Expected drug-specific events & milestones until YE 2019

Key Highlights

- If the results of the Phase II MANTA safety trial are required by the FDA prior to filing for regulatory approval of filgotinib for RA, this could delay US approval by 2 years
- Given that the Phase II NCT03241108 trial is limited to 90 patients in the EU, it is likely that NovImmune will need to initiate a second Phase II trial with a larger number of patients, including US patients, prior to proceeding with a Phase III program for NI-0101 in RA
- The Phase II trial assessing the immunogenicity and safety of Zostavax in RA patients using abatacept, if positive, is likely to boost physician opinion of abatacept’s safety profile in RA, and reduce potential physician concerns that the use of abatacept may negatively impact the effectiveness of some immunizations, as suggested by its US FDA label.

Scope

- The briefing is based on Sociable Pharma’s analysis of clinical trial data from company announcements (press releases, earnings calls) and clinical trial databases (clinicaltrials.gov)
- Sociable Pharma applies disease & drug specific assumptions in order to forecast US & EU approvals for drugs in Phase II development, or higher - these are outlined in the report Appendix
- Forecasts are presented in pipeline forecast figures & detailed tables
- ‘Market Entry’ & ‘Direction of Travel’ positioning analysis for pipeline & currently approved therapies is also provided.

Reasons to buy

- Provides details on forecast US & EU approvals for pipeline drugs in Phase II development or higher
- Includes potential positioning strategies that companies may adopt for their novel assets once they are approved & launched in the market
- Reviews ongoing lifecycle management strategies for existing players in the market
- A detailed methodology allows you to understand the forecast assumptions made, enabling cross comparison with your own internal forecasts.

Companies Mentioned
AbbVie
Abivax
Ablynx
ACEA Biosciences
Acerta Pharma
Akari Therapeutics
Akros Pharma
Amgen
Asana Biosciences
Astellas
AstraZeneca
Bayer
Biocad
Bird Rock Bio
BMS
Boehringer Ingelheim
Can-Fite Biopharma
Celgene
Chemo-Centryx
Cyclacel
Daichii Sankyo
Eddingpharm
Eisai
Galapagos
Genentech
Gilead
GSK
Hanmi
Hutchison Medi Pharma
Innate Pharma
Innocare Pharma
Istesso
Janssen
Japan Tobacco
Jiangsu HengRui
Lilly
Lupin
MacroGenics
MedImmune
Merck KGaA
Mesoblast
Momenta
MorphoSys
Morphotek
MSD
Nektar Therapeutics
Novartis
NovImmune
Noxopharm
Nuevolution
Oscotec
OSE Immuno Therapeutics
Pfizer
Philogen
Principia Biopharma
Protalex
Reata Pharmaceuticals
Regen BioPharma
Regeneron
Rigel Pharmaceuticals
Roche
Rottapharm Biotech
R-Pharm
Sanofi
Sareum
Swedish Orphan Biovitrum
Taiho
Taisho
Takeda
TiGenix
UCB
Valeant
Viela Bio
Vitaeris
WuXi
Xencor