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news.Moberg Pharma and Cadila Pharmaceuticals have signed an agreement for late-stage development and commercialization of BUPI, a novel lozenge formulation of bupivacaine for pain management in oral mucositis patients.
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Under the development and license deal, Cadila will carry out a phase III program in India and is granted an exclusive license to commercialize BUPI in India and Africa, excluding South Africa.
Moberg will receive the rights to use all the information generated from the development program outside India and Africa and a royalty on sales in India and Africa.
The companies may also sign a supply agreement for a subsequent commercial phase.
In June last year, Moberg secured a Eurostars grant which offers co-financing of one phase III study for BUPI in Europe.
The company recently completed a phase II study, which unveiled positive results, supporting the efficacy and safety of BUPI.
The study met its primary endpoint with high statistical significance. The primary endpoint was a measurement of pain in the mouth or pharynx, 60 minutes post administration of BUPI, compared to the average pain during the day for the control group.
The group treated with BUPI had 31% reduction in pain compared to the control group.
Moberg said when the effect in the mouth, excluding the pharynx, was measured, the difference between the groups was even more pronounced.
Treatment with BUPI resulted in an additional pain reduction of 50% compared to standard treatment. No severe adverse events were reported among the patients treated with BUPI.