Navidea Achieves $1 Million in Lymphoseek® Commercial Milestones
- Navidea earns a $500,000 payment from Cardinal Health, Inc. with the sale of the
100,000th Lymphoseek dose -
- Navidea to receive $500,000 payment from SpePharm AG, an affiliate of Norgine, B.V., for EMA
approval of Lymphoseek single dose vial -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) has announced it will receive payments totaling $1 million from two recently
achieved Lymphoseek® commercial milestones under its distribution agreements with U.S. partner Cardinal Health,
Inc. (Cardinal) and European partner SpePharm AG, an affiliate of Norgine B.V. (Norgine). Navidea will collect a $500,000 milestone
payment from Cardinal based on the sale of a 100,000th patient dose of Lymphoseek (technetium Tc 99m tilmanocept)
injection since launch. The Company will also receive a $500,000 payment from Norgine resulting from the European Medicines
Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion for the Lymphoseek 50 microgram kit for
radiopharmaceutical preparation, a reduced-mass, single-dose vial appropriate for the radiopharmaceutical distribution model in
Europe.
“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,” said Jed Latkin, interim Chief Operating Officer and Chief Financial Officer. “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.”
Lymphoseek is approved in the U.S. by the U.S. Food and Drug Administration (FDA) for use in lymphatic mapping to locate lymph
nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative
management and for guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with node negative squamous
cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is indicated in the EU for imaging and intraoperative
detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous
cell carcinoma of the oral cavity.1
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and
commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted
products and platforms including Manocept™ and NAV4694 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 in Europe in November 2014. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea
in conjunction with its subsidiary, Macrophage Therapeutics. 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 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, our
ability to repay our debt, the outcome of the CRG litigation, 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.
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References
1 European Medicines Agency LYMPHOSEEK approval 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002085/human_med_001827.jsp&mid=WC0b01ac058001d124.
Accessed 13 September 2016.
For Navidea Biopharmaceuticals:
Investors & Media
Sharon Correia, 978-655-2686
Senior Director, Corporate Communications
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