September 6, 2016 — Navidea Biopharmaceuticals Inc. announced that it has executed a Letter of Intent (LOI) with Cardinal Health for the sale of all rights, title and interest to Navidea’s Lymphoseek product. The agreement covers all U.S. Food and Drug Administration (FDA)-approved, pending and future oncology diagnostic indications in North America, subject to certain limitations, as well as certain other related assets. Under the terms of the LOI, Navidea would receive $80 million at closing, with future consideration tied to annual sales of the Lymphoseek product and certain sales-based milestones. Total consideration to Navidea would be capped at $310 million.
The deal will allow Navidea to repay all outstanding debt to CRG and accelerate development across the company’s pipeline of diagnostic products, according to Michael M. Goldberg, M.D., chairman of the board of directors for Navidea.
As part of the transaction, Cardinal Health would license back to Navidea a portion of the acquired intellectual property such that Navidea will be able to develop, manufacture, market, sell and distribute new products that do not in any way compete with the current Lymphoseek product, and to continue to manufacture, market, sell and distribute Lymphoseek outside of North America.
Navidea is developing multiple precision-targeted products and platforms, including Manocept and NAV4694, to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek (technetium Tc-99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014.
For more information: www.navidea.com, www.cardinalhealth.com