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Pharmaceutical Industry Dynamics 2010: Licensing Opportunities: Rheumatology
Decision Resources, Inc., June 2010, Pages: 27
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 of the report:
- Business opportunities: Personalized treatments for patients with rheumatic diseases, genetic marker association opportunities, life-cycle management activities, expanding TNF-a 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-infl ammatory 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-a), B-lymphocyte-stimulator (BLyS), B-cellactivating 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, ß-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.
Key terms for this report: Ankylosing spondylitis, Arthritis, Biobetter, Biologic, Biosimilar, Gene expression, Genomewide association, Life-cycle management, Midsize pharma, Osteoarthritis, Rheumatoid arthritis, Spondyloarthropathies, Susceptibility genes, Systemic lupus erythematosus, Systemic sclerosis, Tumor necrosis factor-alpha (TNF-a)
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