Summary

Sociable Pharma’s ‘Treatment Landscape’ contains evaluations of ongoing development activities within the graft versus host disease (GVHD) 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

- Anticipated approval of ATIR101 is delayed both in the EU and US - with the postponed primary completion date in the ongoing Phase III trial delaying the expected US approval by 9 months
- If approved, Ruxolitinib for use in combination with corticosteroids for the treatment of steroid-refractory aGVHD would make it the second drug to receive US approval for the treatment of GVHD after Janssen/AbbVie’s IBR
- Incyte has not only delayed the initiation of Itacitinib's GRAVITAS-309 trial, but significantly extended its duration (from ~2.5 years to ~4.5 years).

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
AbGenomics
Actelion
Adienne
Alexion
Amgen
Bellicum Pharmaceuticals
BMS
Cynata
CytoDyn
Eli Lilly
ElsaLys Biotech
Fate Therapeutics
Genentech
Generon
Gilead
GSK
Incyte
ITC
Janssen
Jazz Pharmaceuticals
Kadmon
Kalytera
Kamada
Kiadis
Mallinckrodt
Medsenic
Novartis
Ocugen
OncoImmune
Pluristem
RegImmune
Rigel Pharmaceuticals
Roche
Syndax
Takeda
TALENT Biotech
Xenikos