Navidea divests development-stage imaging agent NAV5001 for Parkinson’s disease

Navidea previously announced its intention to decrease its R&D expenses by divesting its non-core neuroimaging assets. This agreement follows through on the Company’s commitment to decrease cash burn while moving these neuroimaging programs forward.

"As part of the a strategic realignment that began in early 2014, we have re-focused our resources on the Manocept platform, specifically, commercialization of Lymphoseek and development of immuno-oncology therapeutics targeting activated and tumor-associated macrophages implicated in cancer," said Rick Gonzalez, President and CEO of Navidea.

"Divesting NAV5001 is consistent with this strategy, substantially reduces Navidea’s R&D expense obligations, allows the Company to maintain economic upside, and assigns the product’s rights to an entity we believe has the capability to gain FDA approval."

Under the terms of this agreement, Navidea will transfer the NAV5001 IND, all data, clinical materials, regulatory files (including the Special Protocol Assessment agreements), patents, know-how, and other assets covering the clinical testing of the NAV5001 to Alseres.

Alseres will reimburse Navidea on a fully-documented, pass-through basis for any incurred maintenance costs of the contract manufacturer retroactive to March 1, 2015.

In addition, as requested by Alseres, Navidea will supply clinical support services for NAV5001 on a cost-plus reimbursement basis. In consideration for the rights granted to Alseres, Navidea will receive a milestone payment in connection with NAV5001’s NDA approval by the U.S. FDA and a royalty on subsequent net sales of NAV5001.