Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that emerging oral therapies for multiple sclerosis, including a new drug from Novartis/Mitsubishi Pharma, will capture 25% of the market share by 2020 in the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.
The new Pharmacor report Multiple Sclerosis 2005-2020: Will Emerging Oral Agents Unseat Current Therapies? finds that Novartis/Mitsubishi Pharma's new agent, currently known as fingolimod (also called FTY-720) will outperform other emerging therapies because of its oral formulation, superior efficacy, and acceptable safety profile, although experts temper their excitement with caution because the drug's side-effect profile has not yet fully emerged.
Physicians' and experts' wariness concerning drug safety was prompted by the development of serious infections (three of which proved fatal) in five patients who received Biogen Idec/Elan's Tysabri, which launched in the U.S. market in 2004. For safety concerns, Tysabri was pulled from shelves in 2005 -- following a safety review, the drug was re-approved by the Food and Drug Administration in 2006.
"The history of serious side effects associated with Tysabri has not only impaired its once-promising market potential but also negatively influenced physician opinion of emerging therapies," said Decision Resources Analyst Bethany Kiernan, Ph.D. "As a result of overarching concerns over safety and efficacy, we forecast that no emerging therapies will obtain blockbuster status through 2020."
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