Navidea Divests NAV5001, a Non-Core, Development-Stage Imaging Agent for Parkinson's Disease
April 27 2015 - 7:30AM
Business Wire
-- Company continues sharpened focus on
commercialization of Lymphoseek® and development of its proprietary
CD206-targeted Manocept™ platform –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), 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™ 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.
About Navidea Biopharmaceuticals, Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
commercial stage precision medicine company focused on the
development and commercialization of precision diagnostics,
therapeutics and radiopharmaceutical agents. Navidea is developing
multiple precision-targeted products and platforms including
Manocept™, NAV4694, and NAV5001, to help identify the sites and
pathways of undetected disease and enable better diagnostic
accuracy, clinical decision-making, targeted treatment and,
ultimately, patient care. Lymphoseek® (technetium Tc 99m
tilmanocept) injection, Navidea’s first commercial product from the
Manocept platform, was approved by the FDA in March 2013 and by the
EMA in November 2014. Navidea’s strategy is to deliver superior
growth and shareholder return by bringing to market novel
radiopharmaceutical agents and therapeutics, and advancing the
Company’s pipeline through global partnering and commercialization
efforts. For more information, please visit www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
on third party manufacturers, accumulated deficit, future capital
needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited
marketing and manufacturing experience, risks of development of new
products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company undertakes
no obligation to publicly update or revise any forward-looking
statements.
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Apr 2023 to Apr 2024