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Navidea Biopharmaceuticals, Inc. (NYSE MKT:
), today announced that it
has entered into an agreement with Alseres Pharmaceuticals, Inc. to
terminate the sub-license agreement dated July 31, 2012 for research,
development and commercialization of NAV5001, an agent in Phase 3 clinical
development for early detection of 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(TM) platform, specifically,
commercialization of Lymphoseek(R) 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.
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