Navidea Biopharmaceuticals Signs Letter of Intent with WorldCare Clinical to Partner on Navidea’s Rheumatoid Arthritis Clinical Imaging Workflow and Commercialization
DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals,
Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on
the development of precision immunodiagnostic agents and immunotherapeutics,
today announced that it has signed a letter of intent ("LOI") to partner with
WorldCare Clinical, LLC for the Company's rheumatoid arthritis ("RA") diagnostic
clinical imaging workflow. Per the agreement, WorldCare would serve as
Navidea's central imaging service provider following FDA approval of Navidea's
RA diagnostic. WorldCare Clinical is the world's leading independent contract
research organization dedicated to imaging in clinical trials and brings with
it over 25 years of clinical trial imaging, commercial clinical imaging, and
large-scale data management experience.
WorldCare and Navidea will work in conjunction during the
completion of Navidea's ongoing and planned RA diagnostic trials. The
partnership will work to develop the commercial workflow and infrastructure to
support the full-scale commercialization plan for Navidea's RA diagnostic. It
is anticipated that WorldCare will be the vendor managing the imaging aspects
of the upcoming Phase 2b (NAV3-32) and Phase 3 (NAV3-33) clinical trials, and
will work in parallel to develop an optimized workflow in preparation for
commercial launch in indications in RA.
Jed Latkin, Chief Executive Officer of Navidea, said, "We
are extremely pleased to partner with a world-class imaging vendor in this
necessary component of our RA diagnostic workflow. As we near the Phase 3
clinical trial, we continue discussions with commercial partners, and will provide
an update on developments on that front in the near future."
Dr. Michael Rosol, Chief Medical Officer of Navidea, said, "We
are excited to have this agreement in place and to select WorldCare Clinical as
our imaging partner for the upcoming trials in RA. WorldCare will provide the
central imaging reads that will be integral to the clinical and commercial
success of Tc 99m tilmanocept in RA monitoring applications. The reach and
experience that they bring to the table in managing imaging workflows in
clinical trials and in the clinic has convinced us that they are the right
partner for Navidea at this pivotal stage in development."
Aaron Timm, Chief Executive Officer of WorldCare Clinical,
said, "We are excited to partner with the Navidea team on their upcoming RA
trials as well in the use of Tc 99m tilmanocept in RA monitoring applications. We believe that our radiological, scientific,
and operational expertise will contribute to Navidea's goal of enhancing
patient care by enabling better diagnostic accuracy, clinical decision-making,
and targeted treatment."
About WorldCare Clinical
WorldCare Clinical is a global imaging CRO that employs
scientific expertise, innovative technology, and operational excellence to
maximize the precision and accuracy of a blinded independent central review of
Phase I – IV clinical trial data. The company has worked with thousands of
sites in more than 60 countries. WCC's robust technology platform processes
over 250 million images annually (CT, MRI, X-Ray, Echo, US, PET). Originally founded
in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology,
WorldCare continues to maintain a strategic relationship with the Harvard
Hospital System as well as other leading academic institutions. For more information, please visit www.wcclinical.com.
Navidea Biopharmaceuticals, Inc. (NYSE American:
NAVB) is a biopharmaceutical company focused on the development of precision
immunodiagnostic agents and immunotherapeutics.
Navidea is developing multiple precision-targeted products based on its
Manocept™ platform to enhance patient care by identifying the sites and
pathways of disease and enable better diagnostic accuracy, clinical
decision-making, and targeted treatment.
Navidea's Manocept platform is predicated on the ability to specifically
target the CD206 mannose receptor expressed on activated macrophages. The
Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the
first product developed and commercialized by Navidea based on the
platform. Navidea's strategy is to
deliver superior growth and shareholder return by bringing to market novel
products and advancing the Company's pipeline through global partnering and
For more information, please visit www.navidea.com.
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WorldCare Clinical, LLC
Aaron Timm, CEO