Moberg Pharma has acquired the global rights to a novel topical formulation for the treatment of oral pain.
The company has announced that it has entered into a definitive agreement with Danish Oracain II Aps to acquire all assets as well as global rights to a novel and patent pending oral formulation of the proven substance bupivacaine, for the treatment of pain in the oral cavity. According to Moberg Pharma, the initial target indication is pain management for patients suffering from oral mucositis during cancer therapy. Additional data is planned to be gained through a phase II study during 2014.
Under the terms of the agreement, Oracain is entitled to an upfront payment of SEK 1 million, and an additional SEK 5 million after successful phase II data have been generated. The acquisition and cost for the phase II study will be financed through available cash resources, announced Moberg Pharma in a press release.
Furthermore, Moberg Pharma plans to pursue several routes to generate near term revenues from the product, including through licensing marketing rights to partners in select territories after completion of phase II as well as through sales for compassionate use for individual patients. Moberg Pharma will also examine the possibility for orphan drug status, in the U.S. as well as in EU.
Furthermore, Moberg Pharma 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. The company estimates the peak sales potential of the product to 50-100 m$ assuming successful commercialization in oral mucositis and at least one additional indication.
“We are excited of the opportunity to create a best in class product for a pressing medical need and to make it available to patients within the next few years. Oral mucositis is a debilitating side effect of cancer therapy. Oracain’s clinical data is highly promising and indicates a potential to provide better and longer pain relief to patients. The acquisition is in line with our strategy of providing niche products that can create significant value based on proven molecules with limited development cost, risk and time to market”, said Peter Wolpert, CEO of Moberg Pharma AB.