Navidea Achieves $1 Million in Lymphoseek® Commercial Milestones
September 22 2016 - 6:59AM
Business Wire
- 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.
_____________________________________
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160922005369/en/
For Navidea Biopharmaceuticals:Investors
& MediaSharon Correia, 978-655-2686Senior Director,
Corporate Communications
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