Date: 2015-11-03
Type of information: Development agreement
Compound: MOB-015 (topical formulation of terbinafine)
Company: Moberg Pharma (Sweden) Colep (Portugal)
Therapeutic area: Infectious diseases
Type agreement: development
Action mechanism: antifungal agent. MOB-015 is an internally developed topical formulation of terbinafine building on Moberg Pharma’s experience from its leading OTC product Kerasal Nail®. Oral terbinafine is the gold standard for treating onychomycosis, but associated with safety issues including drug interactions and liver damage. In a recent Phase II study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail, as well as through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the recent phase II study. The results are remarkable, particularly taking into account that the majority of the patients had severely affected nails – on average ca 60% of the nail plate was affected by the infection.
Disease: onychomycosis
Details: * On November 3, 2015, Moberg Pharma announced that Moberg Pharma and Colep entered a development agreement for MOB-015 – a novel topical formulation of terbinafine for onychomycosis. Under the agreement, Colep’s Healthcare Division will share funding by conducting a pharmaceutical development program which will include scale-up of manufacturing processes, stability programs and supply of clinical trial material for the Phase 3 program for MOB-015 as well as the documentation required to file for marketing authorization in the U.S. and EU. Moberg has appointed Colep the exclusive commercial supplier of MOB-015 for the agreed territories. Moberg will own all data and documentation generated from the pharmaceutical development program and plans to initiate a clinical phase 3 program in 2016. The parties will enter a supply agreement for a subsequent commercial phase building on synergies from other products that Colep currently manufactures for Moberg. Financial terms were not disclosed.
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