NEW YORK (Reuters Health) Dec 04 - Miami-based Ivax Corporation said on Wednesday that it has licensed the investigational multiple sclerosis drug cladribine from the Scripps Research Institute.
Under the terms of the exclusive, worldwide licensing deal, Ivax will complete clinical development of the drug and will also be responsible for marketing the final product.
The company said that the cladribine product, which is being developed as an oral formulation that can be given intermittently, could have "important advantages of convenience and tolerance" over current MS drugs, which must be injected on a fixed schedule.
Cladribine is an antineoplastic agent that is currently sold as an anti-cancer therapy for injection or intravenous infusion. Oral forms of the drug are not yet marketed for any indication.
"Studies conducted to date [of the Scripps formulation] include a dramatic and durable reduction in the number and volume of brain lesions seen on magnetic resonance imaging (MRI) in treated patients with active multiple sclerosis," Ivax said.
In particular, a 2-year phase III trial of 51 patients with chronic, progressive MS found that the drug halted progression of MS and induced clinical improvement in many cases.
"A more recent randomized, controlled trial reported in the March 2000 issue of Neurology confirmed the previously reported findings of evidence of reduced brain inflammation in patients treated with cladribine," Ivax added.
"Although interpretation of the clinical effects in this study was complex because the study period was only 1 year and because of the nature of the severe pre-existing disabilities of many of the participants, a trend toward less neurological worsening in the patients treated with cladribine was noted."
Ivax said that it plans additional phase III trials of the drug.
Shares of the company slipped 0.31 to close at 40.19 on the American Stock Exchange on Monday.
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