The company said that initial target indication is pain management for patients suffering from oral mucositis during cancer therapy.
In several pilot studies, Oracain has produced promising clinical data supporting safety and efficacy.
Compared to the currently available non-opioid treatment alternatives for patients with oral mucositis, the novel lozenge formulation provides significantly longer and better pain relief.
Moberg intends to secure additional efficacy data through a Phase II trial in 2014, to be followed by pivotal studies and registration.
As part of the deal, Oracain is entitled to an upfront payment of SEK1m ($151,888), additional SEK5m ($759,440) after successful Phase II data have been generated and a share of future revenues after such revenues have exceeded Moberg’s accumulated development costs incurred prior to launch.
The acquisition and cost for the Phase II trial are financed through available cash resources.
Moberg also intends to pursue several routes to generate near term revenues from the product, including through licensing marketing rights to partners in select territories upon completion of Phase II as well as through sales for compassionate use for individual patients.
The company will also examine the possibility for orphan drug status, in the US as well as in European Union (EU).
In addition, Moberg has identified several additional potential indications for the product beyond oral mucositis, both in the acute and chronic setting, such as Sjögren’s Syndrome, Burning Mouth Syndrome, endoscopic procedures, oral intubations and long-term also OTC use.