Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the recent approval in Japan of Mitsubishi Tanabe Pharma's new intravenous bag formulation of edaravone (Radicut Bag)--which is only available in Japan--will further bolster edaravone's position as the top-selling therapy for acute ischemic stroke in the world's major pharmaceutical markets.
The Pharmacor 2010 finding from the topic entitled Acute Ischemic Stroke reveals that, following its expected launch in Japan this year, the new formulation of edaravone will increasingly capture share of edaravone use through 2018, thanks to its more-convenient administration--an advantage in the acute care setting. As a result, Decision Resources has revised its sales forecast for edaravone, which is now expected to garner $286 million in 2018 in Japan.
Despite repeated failures in clinical trials, new neuroprotectants continue to be investigated for the treatment of acute ischemic stroke. In December 2009, D-Pharm announced that it had enrolled the first patient into a pivotal Phase III clinical trial of its neuroprotectant DP-b99. This large, multinational study will test the safety and efficacy of the drug within an expanded therapeutic time window--one to nine hours post stroke. Although previous studies showed that DP-b99 has a favorable side-effect profile, a critical attribute for any neuroprotectant, efficacy results were mixed.
"Disillusionment continues to spread among stroke experts regarding the promise of acute pharmacological neuroprotectants for acute ischemic stroke," said Decision Resources Analyst Jonathan Searles. "In light of past failures and interviewed experts' uncertainty about DP-b99, Decision Resources does not forecast a launch date for this agent at this time but we continue to follow its development with interest."
The Pharmacor 2010 findings also reveal that the development of novel neurorestorative therapies continues to advance. Earlier this month, Stem Cell Therapeutics announced that a Data Safety Monitoring Board had provided a final recommendation to continue an ongoing Phase IIb clinical trial for NTx-265 -- a drug treatment regimen that is designed to stimulate a patient's own stem cells to regenerate damaged brain tissue. Additionally, ReNeuron announced earlier this month that it received final regulatory approval by U.K. authorities to begin a Phase I study for its neural stem cell therapy, ReN-001.
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