BURLINGTON, Mass., June 12, 2014 /PRNewswire/ -- Decision Resources Group finds that three therapies, Teva's Huntexil, Auspex's SD-809 and Raptor's Procysbi, will likely receive regulatory approval for Huntington's disease (HD) in the United States and the EU5 markets (Germany, France, Italy, Spain and United Kingdom) during the 2013-2023 study period. Notably, all three therapies are expected to be used primarily to control and relieve motor symptoms. Despite the very high unmet need for disease-modifying therapies in HD, such as gene therapies, none are expected to enter the market during the study period, owing to the considerable challenges of modulating gene expression in the human brain. Interviewed experts indicate awareness of the development of Isis Pharmaceuticals' ISIS-HTTRX (an antisense oligonucleotide currently in preclinical studies) but acknowledge that serious barriers remain before this approach could provide real benefits to their patients.
Other key findings from the Niche Markets and Rare Diseases: Huntington's Disease report:
- Opportunities for new product development: Because the unmet need in HD is so severe, regulators are likely to quickly approve a disease-modifying therapy offering even a modest reduction in disease progression. Interviewed neurologists agree that they would quickly embrace any therapy offering measurable improvements in loss of brain volume and/or reduction in cognitive impairment.
- Modest increase in the size of HD population: Driven by an aging population in the U.S. and Europe, the number of diagnosed prevalent cases of HD in the six major markets under study will increase by approximately 8 percent through 2023.
- Off-label use of antipsychotic drugs and antidepressants: Interviewed experts agree that antipsychotic drugs offer meaningful behavioral and hyperkinetic movement benefits for many of their HD patients. Physicians report that common adverse effects associated with antipyschotics, such as weight gain, sedation and extrapyramidal symptoms, can be beneficial in HD patients who struggle to control movements, maintain weight and achieve adequate rest. High levels of off-label prescribing of antipsychotic drugs and antidepressants will likely continue throughout the study period as no emerging therapies appear to offer significant behavioral or mood benefits at this time.
Comments from Decision Resources Group Analyst Jing Wu, M.S., M.B.A.:
- "HD is caused by mutations in a single gene and hence represents an ideal disorder to target with gene therapy. However, there are currently no available technologies to deliver and sustainably modulate gene expression in the brain neurons, and this critical challenge needs to be overcome before we see gene therapies developed for the treatment of HD."
- "We expect Huntexil to launch before SD-809 (Auspex) and Procysbi in the U.S. and European markets, and to have good efficacy and tolerability; Teva will likely be able to leverage its long-established presence in the neurological diseases space to quickly drive uptake of Huntexil, which we expect will capture a greater patient share than the other two new therapies by 2023."
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