The payment from Cardinal Health is based on the sale of its 100,000th dose of Lymphoseek since launch, while the payment from SpePharm AB comes due to a positive opinion from the European Medicines Agency’sCommittee for Medicinal Products for Human Use for a 50 microgram kit for radiopharmaceutical preparation.
Lymphoseek, FDA-approved since 2014, is indicated for sentinel lymph node detection in breast cancer, melanoma, and oral cavity head and neck cancers.
“We are pleased with the meaningful progress that Navidea and its partners have made in our commercial distribution efforts in both the U.S. and Europe. These milestones reflect the growing acceptance of Lymphoseek in the U.S. for improving the outcomes in patients with melanoma, breast and oral cavity cancers and signal the expected European launch of Lymphoseek in Q42016,” interim COO & CFO Jed Latkin said in a press release.
Earlier this month, Navidea said today it inked a letter of intent with Cardinal Health to sell its Lymphoseek injection for up to $310 million. The sale includes all current FDA-approved indications, as well as future oncology diagnostic indications in North America and other related assets, Navidea said.
Through the deal, Navidea is slated to receive $80 million upon closing, with future considerations tied to annual sales of Lymphoseek and sales-based milestones.