Coronado Biosciences said today it has exclusively in-licensed an intravenous (IV) formulation of tramadol for the U.S. from Revogenex Ireland. The deal generated a $2 million upfront payment for Revogenex, which could receive an undisclosed amount of additional payments tied to development milestones, plus royalties.

Coronado said it will transfer the tramadol license to Avenue Therapeutics, a new subsidiary that will focus on acquiring, licensing, developing, and commercializing products for the U.S. hospital market.

Avenue Therapeutics plans to launch a Phase III development program of IV tramadol for the management of post-operative pain later this year. Under their licensing deal, Avenue Therapeutics and Coronado will assume sole responsibility for development and commercialization of IV tramadol in the U.S.

“Forming this subsidiary that focuses on hospital-based products is a further step in our strategy to diversify our business. We believe that IV tramadol fills an important unmet need in the acute care setting,” Lindsay A. Rosenwald, M.D., Coronado's chairman, president and CEO, said in a statement.

Coronado identified diversification of its product base as a priority in its most recent 10-Q quarterly filing for the third quarter of 2014. That base has long been anchored by new immunotherapy agents for the treatment of autoimmune diseases and cancer, namely CNDO-201 or Trichuris suis ova (“TSO”), and CNDO-109.

Added Jeffrey Ping, Ph.D., Revogenex CEO and co-founder: “IV Tramadol represents the first of many products we are developing, and we look forward to the successful partnership with Coronado to introduce IV Tramadol into the U.S. market”

Tramadol is a centrally acting synthetic opioid analgesic marketed under brand names Ultram, ConZip, and Ryzolt, as well as in generic versions. Tramadol is indicated for moderate to moderately severe pain, and is available as immediate release or extended-release tablets in the U.S. As of August 18, 2014, Tramadol has a Schedule IV classification under the federal Controlled Substances Act.

According to Coronado, oral tramadol sales have been reported as approximately $1.2 billion in the U.S. in 2014.

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