Emerging oral therapies for multiple sclerosis, including a new drug from Novartis/Mitsubishi Pharma, will capture a 25% market share by 2020 in the USA, Japan, France, Germany, Italy, Spain and the UK, according to a study by health care research and advisory company Decision Resources.
The new Pharmacor report, Multiple Sclerosis 2005-2020: Will Emerging Oral Agents Unseat Current Therapies? predicts 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. At its last R&D presentation, Novartis said that fingolimod was one of its drug candidates which is advancing into late-stage testing (Marketletter December 4, 2006).
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 MS drug Tysabri (natalizumab), which launched in the US market in 2004. Due to safety concerns, Tysabri was pulled from shelves in 2005 but, following a safety review, the drug was re-approved by the Food and Drug Administration in 2006 (Marketletters passim).
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