Abstract
Introduction:
The ability to develop personalized treatments for rheumatic disease will
ultimately come from the exploitation of genetic markers associated with
specific diseases. Such additional, alternative treatments for rheumatic
diseases will provide patients with more opportunities for successful
treatment. No one opportunity fits all companies. In this report, we look at
the rheumatology market, major brands sold today, and drugs in late-stage
development. We investigate opportunities for developing biosimilars and
biobetters and opportunities afforded by the activities of midsize European
Pharma companies. Midsize companies are often a fertile hunting ground for
larger companies looking to inlicense or acquire drug candidates or marketed
drugs. Finally, we discuss three important strategies to consider when
developing drugs for rheumatology markets.
Questions Answered in This Report:
- Biogen Idec' s CFO, Paul Clancy, has described ocrelizumab as a
"next-generation humanized and improved" Rituxan. What is ocrelizumab' s
current status? Which clinical trials are active?
- The South Korean company Samsung Electronics plans to invest $389 million
in biosimilars over five years and "strategically" and "aggressively" grow a
biosimilars business. What biosimilar opportunities exist for rheumatic
diseases? When and where will the first biosimilar rheumatology products come
to market?
- Teva Pharmaceutical Industries' CEO, Shlomo Yanai, says his company is
establishing a future leadership position in biosimilars markets. What
strategies is Teva using to gain a major foothold in future biosimilars
markets? What other companies plan to be active in biosimilar and biobetter
development?
- Gene associations can be exploited to develop more-personalized rheumatic
disease therapies. What genetic risk factors were recently linked to
rheumatic diseases? What types of markers have been associated with these
diseases? Where has genome-wide expression profiling shown its value?
- Elmar Schnee, head of pharmaceuticals for Merck KGaA, told investors that
his company is excited about the potential of fibroblast growth factor-18
(FGF-18) to treat osteoarthritis. Why is FGF-18 an attractive drug? What
other R&D candidates are in development by midsize European Pharma companies?
Which of these companies have the stronger R&D programs in rheumatology and
offer better partnering opportunities? Which of these companies are basically
one-rheumatology-product companies?
- George S. Mack, D.M.D., managing director of BioDecade, says, "It is
difficult to say whether rheumatology drugs have withstood the test of time,
or whether time stood still in terms of new drug discovery." How important
are life-cycle management strategies in rheumatology markets? What strategies
is UCB using to extend Cimzia' s market reach? What is Miles White, CEO of
Abbott, planning to do to maximize the company' s Humira franchise?
Scope:
Business opportunities: Personalized treatments for patients with
rheumatic diseases, genetic marker association opportunities, life-cycle
management activities, expanding TNF-α inhibitor markets, UCB' s strategy
to expand the Cimzia (certolizumab pegol) franchise, Abbott' s plans to expand
the Humira (adalimumab) franchise, next-generation biologic and biobetter
opportunities, improvements to CD20-targeting biologics.
Rheumatic diseases: Gout, osteoarthritis, rheumatoid arthritis,
juvenile idiopathic arthritis, juvenile rheumatoid arthritis,
spondyloarthropathies, ankylosing spondylitis, psoriatic arthritis, reactive
arthritis, systemic lupus erythematosus, systemic sclerosis,
cryopyrin-associated periodic syndromes (CAPS), familial cold
auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS).
Rheumatic disease markets: Major brands, 2009 worldwide sales, 2016
worldwide sales, biologics, monoclonal antibodies (MAbs), near-term market
competition, late-stage drugs.
Drug classes and targets: NSAIDs, DMARDs, cyclooxygenase-2 (COX-2),
CD20, interleukin-6 receptor (IL-6R), tumor necrosis factor-alpha
(TNF-α), B-lymphocyte-stimulator (BLyS), B-cell-activating factor
(BAFF), spleen tyrosine kinase (syk), small nuclear ribonucleoparticle
peptide, CD22, Jak-3 kinase, cyclooxygenase-inhibiting nitric oxide donator
(CINOD), endothelin receptor, dihydroorotate dehydrogenase (DHODH), hyaluronic
acid, xanthine oxidase, fibroblast growth factor-18, interleukin-20 (IL-20),
C5aR receptor, interleukin-6 (IL-6), CD40L.
Late-stage program updates: Biogen Idec and Roche terminate
ocrelizumab' s development for RA and SLE; Human Genome
Sciences/GlaxoSmithKline' s Benlysta fails to meet one secondary end point;
NicOx' s Naproxcinod (NO-naproxen) is not endorsed by an FDA panel.
Biosimilars: Biologics Price Competition and Innovation Act of 2009,
Patient Protection and Affordable Care Act (Public Law 111-148), expected
market entry of five biosimilars in RA markets, next-generation biologics,
biosimilar dealmaking, South Korea' s interest in biosimilars, developing
biobetters, Ratiopharm acquisition, Big Pharma' s interest.
Midsize European Pharma companies: Companies with marketed rheumatology
products, companies with R&D programs for rheumatic diseases, Phase III/IV
programs, pay-for-results arrangements.
Gene associations linked with rheumatic diseases: Genetic risk factors,
genome-wide association studies, IL-23 and IL-1 pathways, disease
susceptibility, chondrogenic progenitor cells, regenerative therapy,
β-chain of the class II HLA-DR antigen, peptidylarginine deiminase-4,
tyrosine phosphatase, lymphoid phosphatase, Fc receptor-like molecule-3, CD40,
six genetic loci associated with autoantibody-positive RA, shortening of
telomeres, gene expression profiling, early markers of response to TNF
inhibition therapy, pathways for regulating immune responses and cell
division, kallikrein genes, DNA methylation markers.
Table of Contents
Executive Summary
- Strategic Considerations
- Stakeholder Implications
Looking for Opportunities
Rheumatic Diseases - A Lifetime of Therapy
Major Brands for Rheumatic Diseases
Update on Rheumatic Disease Drugs in Late-Stage Development
- Near-Term Market Competition
- Ocrelizumab' s Clinical Program Suspended
- Benlysta' s Failure to Meet Secondary End Point in BLISS-76 Trial
- NicOx' s Naproxcinod for Osteoarthritis Not Endorsed by FDA Panel
Biosimilar Opportunities
- The First Biosimilars for Rheumatic Diseases
- Recent Dealmaking in Biosimilars
Opportunities at Midsize European Companies
- Actelion Pharmaceuticals
- Almirall
- Ferring Pharmaceuticals
- Ipsen
- Merck KGaA
- Novo Nordisk
- UCB
Three Business Development Strategies for Rheumatic Disease Therapy
- Gene Associations Linked with Rheumatic Diseases
- Expanding Market Reach
- Next-Generation Biologics, Biosimilars, and Biobetters
Tables
- 1. Worldwide Sales of Rheumatic Disease Brands, 2009 and 2016
- 2. Timeline of Biosimilar Market Entry for Rheumatoid Arthritis
- 3. Select Companies with Disclosed Biosimilar Development Programs for
Rheumatic Diseases
- 4. R&D Rheumatology Programs of Select Midsize European Pharma Companies
- 5. Recent Gene Expression Profi ling Studies That Link Specifi c Markers
with Rheumatic Diseases
- 6. Improvements to CD20-Based Biologics: Next-Generation Biologics and
Biobetters
Figures
- 1. Decision Resources Analysts' Forecast of Late-Stage Rheumatology Brand
Sales, 2016
- 2. Life-Cycle Management Timeline for Tumor Necrosis Factor-Alpha
Inhibitors, U.S. Approval Dates
