Moberg Pharma and Colep have entered a development agreement for MOB-015, a novel topical formulation of terbinafine for onychomycosis (nail fungus).
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.
“We are excited to further build on the synergies being generated from our current collaboration with Colep. This agreement leverages Colep’s expertise and manufacturing capabilities for the late-stage development and subsequent commercialization of MOB-015. For Moberg, this agreement reduces our development expenses for phase 3 and establishes an attractive supply cost for the commercial phase. Forming innovative partnership models supports Moberg’s commitment to bringing novel treatments to patients in underserved niches, and further advances our vision to become the leading player in onychomycosis,” said Peter Wolpert, CEO of Moberg Pharma AB.
“We are delighted to expand our successful collaboration with Moberg Pharma to now include MOB-015. We decided to co-invest in the project based on the significant market potential for MOB-015 as well as the strong track record established by the other Moberg products Colep currently manufactures“, said Ludwig Bastiaansen, Managing Director, Healthcare Division, Colep.
Colep Healthcare Division provides dedicated manufacturing (filling and packing) capabilities, for pharmaceuticals, medical devices and high-end applications.
Source: Moberg Pharma