Psoriasis KOL Insight

June 2016 | | ID: P8E7FA8628CEN
FirstWord

Abstracts

Will innovative drugs or biosimilars dominate in psoriasis?

The emergence of biosimilar anti-TNFs could expand access to established biological therapies for psoriasis. However, recently launched therapies and pipeline agents can deliver better outcomes, for longer. Which options are most likely to gain ground in this increasingly crowded treatment landscape?

We interviewed 12 US and EU payers with expertise in formulary development and drug reimbursement to get their perspective on the challenges facing the MS market. Plus you’ll find out how payers view pipeline MS treatments, what advice they have for Pharma, and which clinical trials to watch.

Covering 9 currently marketed drugs, and 10 currently in clinical trials, the report reveals candid insights about the psoriasis landscape from 12 key opinion leaders (KOLs) in North America and Europe.

You’ll learn which treatments satisfy dermatologists’ objectives for psoriasis treatment, whether oral therapies are overtaking injectables, and which pipeline drugs—both biosimilar and innovative molecules—are likely to succeed.

TOP TAKEAWAYS

• Despite numerous treatments, unmet needs persist: KOLs are particularly eager to see longer-term efficacy and cost-effectiveness. Find out what else they are looking for in future therapies.
• Limited uptake of current oral therapies: KOLs are enthusiastic about oral treatments, but they want more than oral delivery. What will pipeline oral agents have to offer to overtake injectables?
• Biosimilars are gaining acceptance: Favourable reimbursement decisions could intensify competition in the psoriasis market. Find out about the additional factors that will affect their uptake in real-world clinical practice.
• IL-targeting therapies are not created equal: The current gold standard, Stelara (ustekinumab), targets IL-12/23 but emerging competitors focus on IL-17 and IL-23 alone. How do KOLs perceive these next-generation mAbs?
• New pathways elicit mixed feedback: Early-stage candidates exploit pathways previously untargeted in psoriasis. Discover which ones excite KOLs, and which ones don’t.
• Safety is a key concern: Concerns about side effects and long-term safety hang over several newer treatments for psoriasis. Find out what they are and how KOLs expect them to influence use.
• Personalised care is on the horizon: KOLs believe outcomes from current therapies can be improved, and express optimism about the possibility of personalising treatment. How could this trend shape the future marketplace?

Brands covered

Marketed:

• Humira (adalimumab, Abbvie)
• Enbrel (etanercept, Amgen)
• Benepali (etanercept biosimilar, Biogen)
• Flixabi (infliximab biosimilar, Biogen)
• Otezla (apremilast, Celgene)
• Remsima/Inflectra (infliximab biosimilar, Celltrion/Pfizer)
• Taltz (ixekizumab, Eli Lilly)
• Remicade (infliximab, Merck & Co./Janssen)
• Cosentyx (secukinumab, Novartis)

Pipeline

• Cosentyx (secukinumab, Novartis)
• Brodalumab (Amgen/AstraZeneca/Leo Pharma)
• Risankizumab (BI 655066, Boehringer Ingelheim/AbbVie)
• Piclidenoson (CF101, Can-Fite Biopharma)
• Guselkumab (anti-IL23, Janssen/Morphosys)
• Amiselimod (MT-1303, Mitsubishi Tanabe Pharma/Biogen)
• Xeljanz (tofacitinib, Pfizer)
• Etanercept biosimilar (GP2015. Sandoz [Novartis])
• Amilumab (MT-203, Takeda/Amgen)
• Cimzia (certolizumab pegol, UCB)

Key Opinion Leaders Interviewed for This Report

KOLs from North America

• Steven R. Feldman. Professor of Dermatology, Wake Forest University Health Sciences, NC.
• Joel Gelfand. Associate Professor, Department of Dermatology and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, PA.
• Neil Korman. Professor of Dermatology, Department of Dermatology, University Hospitals Case Medical Center, OH.
• Jeffrey Weinberg. Attending, Department of Dermatology, Mount Sinai St. Luke's Roosevelt, NY.
• Alan Menter. Chairman of the Division of Dermatology at Baylor University Medical Center, Waco, Texas.
• Stephen Tyring. Clinical Professor in the Departments of Dermatology, Microbiology/Molecular Genetics and Internal Medicine at the University of Texas Health Science Center, Houston, TX.
• Jashin J. Wu. Dermatologist, Kaiser Permanente, Los Angeles, CA.

KOLs from Europe

• Manuelle Viguier. Principal Clinical Investigator, Department of Dermatology, AP HP Hôpital Saint Louis, University Paris Diderot, Sorbonne Paris Cité, Paris, France.
• Carle Paul. Professor and Chairman of the Department of Dermatology at Paul Sabatier University, Toulouse, France.
• Antonio Costanzo. Full Professor of Dermatology, the Chairman of Dermatology and the Director of the Skin Pathology Laboratory, The Humanitas University, Milan, Italy.
• Robert Strohal. Department of Dermatology and Venerology, Federal University Teaching Hospital, Feldkirch, Austria.
• Mona Ståhle. Chair of the Dermatology and Venereology Unit, Department of Medicine, Karolinska Institute, Stockholm, Sweden.

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Contents

1. EXECUTIVE SUMMARY

2. RESEARCH OBJECTIVES

3. RESEARCH FOCUS

4. THE CURRENT TREATMENT LANDSCAPE FOR PSORIASIS

4.1. Key clinical unmet needs in psoriasis
4.2. Therapies with longer-term efficacy
4.3. An oral therapy that is as effective as its injectable peers
4.4. Therapies targeting site-specific psoriasis outbreaks
4.5. Targeted therapies for special patient populations
4.6. Therapies that are more cost efficient

5. CURRENT THERAPIES USED IN THE TREATMENT OF PSORIASIS

6. ANTI-TNFS

6.1. Enbrel (etanercept; Amgen/Pfizer)
6.2. Remicade (infliximab; Merck & Co./Janssen Biotech)
6.3. Humira (adalimumab; AbbVie)

7. BIOSIMILAR ANTI-TNFS

7.1. Remsima/Inflectra (Infliximab; Celltrion/Hospira)
7.2. Flixabi (Infliximab; Samsung Bioepis)
7.3. Benepali (etanercept; Samsung Bioepis)
7.4. GP2015 (Etanercept; Sandoz)
7.5. ABP 501 (Adalimumab; Amgen)
7.6. The position of biosimilar Anti-TNFs in the treatment of psoriasis
7.7. The future of anti-TNFs in the treatment of psoriasis

8. ANTI-IL12/23S

8.1. Stelara (ustekinumab; Janssen Biotech)

9. ANTI-IL17AS

9.1. Cosentyx (secukinumab; Novartis)
9.2. Taltz (ixekizumab; Eli Lilly)

10. PDE4 INHIBITORS

10.1. Otezla (apremilast; Celgene)

11. KEY LATE-STAGE PSORIASIS PIPELINE PROGRAMME ANALYSIS

11.1. Cimzia (Certolizumab; UCB/Dermira)
11.2. Guselkumab (anti-IL23 mAb; Janssen Biotech/MorphoSys)
11.3. Risankizumab/BI 655066 (anti-IL23 mAb; Boehringer Ingelheim)
11.4. Brodalumab (anti-IL17R mAb; Valeant/AstraZeneca/Leo Pharma)
11.5. Tofacitinib (anti-JAK3; Pfizer)

12. EARLIER PIPELINE THERAPIES

12.1. Piclidenoson (CF101; Can-Fite Biopharma)
12.2. Namilumab (MT-203; Takeda/Amgen)
12.3. Amiselimod (MT-1303; Mitsubishi Tanabe Pharma/Biogen)

13. THE FUTURE OF PSORIASIS TREATMENT

14. APPENDIX

14.1. KOL biographies
14.2. KOLs from North America
14.3. KOLs from Europe