Navidea Biopharmaceuticals Inc.

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.

Navidea Biopharmaceuticals Inc. last week announced that the first patient has been enrolled in a clinical study evaluating Lymphoseek (technetium Tc 99m tilmanocept) injection in women with known cervical cancer.

Navidea Biopharmaceuticals Inc. received initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant up to $1.8 million from the National Cancer Institute (NCI), National Institutes of Health (NIH). The grant will be used to fund preclinical studies examining the safety of intravenous (IV) injection of Tc99m tilmanocept, a Manocept platform product.

Navidea Biopharmaceuticals Inc. announced plans to move forward with a joint study of the ability of Tc99m-tilmanocept, a Manocept platform product, to localize in high-risk atherosclerotic plaques. The study — funded through a $321,000 Phase 1 Small Business Innovation Research (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI), National Institute of Health (NIH) — will be conducted with Massachusetts General Hospital (MGH) and Harvard Medical School.

Navidea Biopharmaceuticals announced that results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc-99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) were presented at the 2015 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference. The study measured injection site pain in patients with breast cancer undergoing lymphoscintigraphy. Results of the randomized, double-blinded trial — led by Anne Wallace, M.D., professor of surgery at University of California, San Diego School of Medicine — highlighted that fTcSC caused statistically significant greater levels of pain after injection compared to Lymphoseek.