Oral drugs for the treatment of RA have hogged the limelight in the last 2-3 years but oral drugs for Psoriasis have yet to make a similar impact. Pfizer’s Tofacitinib (formerly CP-690,550, PhIII, JAK 1/3 is poised for a launch in 2012 and we expect others to follow from 2013-14 onwards. Will these drugs place the foundation for “Oral Therapies for Psoriasis” or is that area still in the nascent stage?
The lack of targeted immune therapies other than TNF-a inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment alternatives. Anti IL-12/ IL-23, anti-IL-17, IL-13, CD-6, JAK3, PDE4 inhibitors are in late stages of clinical development and could set the stage for new biologics and oral options. While there is still ample room for an efficacious affordable oral therapy to tap the mild to moderate RA pts population where biologics have not made a dent, long-term data and durability outcomes need to be established in pts with moderate to severe plaque psoriasis.
In the report, “Psoriasis: Oral and Novel Biologics to Change Future Market Dynamic”; we are sharing our thoughts on some key drugs and targets in the pipeline for the treatment of Psoriasis. Successful launch of a few of these drugs could bring a dynamic change in the current market share of the approved drugs and validated targets.
Noteworthy amongst them are:
- The Oral options- JAK inhibitors led by PFE’s Tofacitinib and CELG’s PDE4 inhibitor, Apremilast.
- New or better biologics include IL12/23 inhibitors and IL-17/IL17A inhibitors
- Unlike RA, Psoriasis treatment demands topical drug intervention and several of the oral drugs are being formulated to meet the need and proved an end to end solution. The aim is to fulfill the unmet need in Mild- moderate patients, TNF-non responders, and of course, affordability.
- The report discusses the disease, pathophysiology, current treatment options, limitations and market potential and future growth in detail.
- Competitive Landscape of the drugs in pipeline – Oral, Biologics, and Topical and the comparative efficacy safety data could provide insight on how this therapy treatment paradigm could unfold in the future and identify investment opportunities.
- Upcoming milestones related to the drugs and companies mentioned are highlighted in the report to help you decide on the long and short term investment opportunity.
2. What is the unmet need in Psoriasis?
2.1. Limited Options for Anti-TNF Non-Responders in Psoriasis
2.2. Limitations of Anti-TNFs
2.3. Scope for entrants with better efficacy and safety profiles
2.4. Specific unmet need and emerging therapies in PsO and PsA
3. Emerging Therapies
3.1. Biologics/ Next-Generation Biologics for Psoriasis
3.1.1. IL-12 and IL-23 Inhibitors
3.1.2. Interleukin-17 (IL-17) And Receptor (IL-17RA)
3.1.3. Other Targets
3.2. Oral treatments
3.2.1. Targeting JAK-STATs
3.2.2. Phosphodiesterases 4 (PDE4) Inhibitor
3.2.3. Targeting Other Kinases
3.2.4. Will the oral drugs being investigated in RA work for Psoriasis?
3.2.5. Other Targets
3.3. Topical treatments
4. Upcoming milestones
5. Market Outlook
5.1. Current market overview and Commercial potential of upcoming therapies
6. Etiology and Pathophysiology of Psoriasis
6.1. Types of Psoriasis
6.2. Psoriatic Arthritis (PsA) – Disease Overview
6.3. Assessment of PsA – Treatment Efficacy Tools
6.4. Aftermaths of PsA
7. Current Treatment options
7.1. Comparison of the current data with approved biologics/ other drugs for Psoriasis
7.2. Treatment guidelines and factors influencing drug selection
1 Approved/ Marketed Products
2A Psoriasis’ Pipeline: Small Molecules – Oral
2B Psoriasis’ Pipeline: Small Molecules – Topical
3 Psoriasis’ Pipeline: Biologics
4 Select Late- & Mid-Stage Pipeline: Plaque Psoriasis
5 Select Late- & Mid-Stage Pipeline: Psoriatic Arthritis
6 Clinical Data Comparison: Plaque Psoriasis – Biologics
7A Tofacitinib: PASI Improvement From Baseline
7B Tofacitinib: Improvement In Quality-of-Life (QoL) Measures
8 Clinical Data Comparison: Plaque Psoriasis – Oral
9 Other Targets In Clinical Development For RA
10 Genes Associated With Psoriasis Susceptibility
11 Competitive Landscape: Plaque Psoriasis
12 Competitive Landscape: Psoriatic Arthritis
13 Distinct Features: Subtypes of PsA
1 The Structure And Function Of The Cytokines Il-12 And Il-23
2 PHOENIX 1 Clinical Data: PASI 75 Through Wk 40
3 Clinical Data: ACCEPT – Head-To-Head Trial With Enbrel
4 MK-3222 Neutralizes IL-23, Specifically
5 IL-17R Family Ligand–Receptor – Main Structural Features
6 IL-17-Induced Signaling Pathways
7 Regulation of JAK–STAT Signaling
8 ASP015K – Changes From Baseline In PASI At Day 42
9 PDE Inhibitors Crosstalk
10 AEB071 – PASI 75 Reduction Compared With Baseline
11 S1P Receptors As Barrier-Oriented Therapeutic Molecules
12 AN2728 – PhIIb (204 Study) Data
13 Psoriasis Treatment Ladder (Schematic)
14 Topical: Worldwide Market Share
15 Biologic - Psoriasis: US Market Share And Product Sales
16 US Psoriasis Market Estimation
17 Proposed Schema of The Evolution of A Psoriatic Lesion
18 Distribution of Psoriasis Severity
19 Use of Therapies Depending on The Disease Severity
20 Targeted Therapy Classification Based On Pathogenesis
21 Comparison of GRAPPA And AAD Treatment Guidelines
- Johnson & Johnson
- Bristol-Myers Squibb
- Maruho Co.
- Sheba Medical
- Lupin pharma
- Can-Fite biopharma
- VBL Therapeutics
- Barrier Therap./ Stiefel
- Forward-Pharma GmbH
- Sirtris (now GSK)
- Anacor pharma
- Revotar biopharma
- Provectus pharma
- Eli Lilly