- Strategic partnership provides market
development, sales and marketing infrastructure for Lymphoseek
expansion into European marketplace –
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and SpePharm
AG (an affiliate of Norgine BV), a European specialist
pharmaceutical company with an extensive pan-European presence,
today entered into an exclusive sublicense agreement for the
commercialization and distribution of Lymphoseek® 250 microgram kit
for radiopharmaceutical preparation (tilmanocept) in the European
Union. Under the terms of the agreement, Navidea will receive an
upfront payment of $2 million and is eligible to receive additional
milestone payments up to $5 million, as well as royalties on
European net sales.
Lymphoseek is a receptor-targeted, radiopharmaceutical imaging
agent approved by the U.S. Food and Drug Administration in 2013 and
by the EU in November 2014. Lymphoseek is approved in Europe for
imaging and intraoperative detection of sentinel lymph nodes in
patients with breast cancer, melanoma, or localized squamous cell
carcinoma of the oral cavity. In these procedures, key lymph nodes
adjacent to a primary tumor, that may contain tumor metastases, are
identified and biopsied to determine if cancer has spread to these
lymph nodes.
“Launching Lymphoseek into new global markets is integral to
Navidea’s corporate growth strategy. We believe that Norgine’s
commercial, medical and development expertise, combined with its
well-established infrastructure and strong presence in the European
marketplace, make it an ideal commercialization partner to gain
country-by-country reimbursement and drive Lymphoseek adoption,”
said Rick Gonzalez, President and Chief Executive Officer of
Navidea. “We anticipate a successful and mutually-beneficial
partnership with Norgine based on synergistic core competencies,
our shared vision for value creation and our strong commitment to
providing highly-differentiated products that improve the diagnosis
and treatment of disease for patients with unmet medical
needs.”
“This agreement with Navidea underscores Norgine’s vision to be
the partner of choice and facilitates the growth and expansion of
our specialist product portfolio to help improve the treatment of
patients throughout Europe,” said Peter Stein, Chief Executive
Officer of Norgine. “We look forward to fully engaging our sales
force to support commercial launch activities in a marketplace
requiring a new alternative.”
“Securing a partner with the commitment to market access
development was especially important to us since, unlike the United
States where institutions typically rely on unit dose distribution
of radiopharmaceutical products by specialized radio-pharmacy
distributors, institutions in Europe purchase non-radiolabeled
material and compound the finished product on-site,” added Mr.
Gonzalez “As a specialist pharmaceutical company, Norgine is
optimally positioned to interface directly with a targeted surgical
oncologist customer base with a dedicated sales force. We expect
Norgine to begin market access work immediately in the major
markets in Europe with the goal of supporting commercial launch
sometime in early 2016.”
Under terms of the exclusive license agreement, Navidea will
supply Lymphoseek product to Norgine; however, Navidea will
transfer responsibility for regulatory maintenance of the
Lymphoseek Marketing Authorization to Norgine. Norgine will also be
responsible for pricing, reimbursement, sales, marketing, medical
affairs, and regulatory. In connection with entering into the
agreement, Navidea will be entitled to an upfront payment of $2
million, milestones totaling up to an additional $5 million, as
well as royalties on European net sales. The initial territory
covered by the agreement includes all 28 member states of the
European Economic Community with the option to expand into
additional geographical areas. Additional terms of the agreement
were not disclosed.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. Overall in the U.S., solid tumor cancers may
represent up to 1.2 million cases per year. The sentinel node label
in the U.S. and Europe may address approximately 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
annually.
EU Lymphoseek® 250 micrograms kit for radiopharmaceutical
preparation (tilmanocept)
Indication and Important Safety Information
Radiolabelled Lymphoseek is indicated for imaging and
intraoperative detection of sentinel lymph nodes draining a primary
tumour in adult patients with breast cancer, melanoma, or localised
squamous cell carcinoma of the oral cavity.
External imaging and intraoperative evaluation may be performed
using a gamma detection device.
Important Safety Information about Lymphoseek for EU &
U.S. patients
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers.
In clinical trials, no patients experienced serious adverse
reactions and the most common adverse reactions were injection site
irritation and/or pain (<1%).
Prescribing information and more information about Lymphoseek
for EU patients is available at:
http://ec.europa.eu/health/documents/community-register/html/h955.htm
For full prescribing information and more information about
Lymphoseek for U.S. patients, please visit: www.lymphoseek.com.
About Norgine
Norgine is a European specialist pharmaceutical company that has
been established for over 100 years. Norgine provides expertise and
‘know how’ in Europe to develop, manufacture and market products
that offer real value to healthcare professionals, payers and
patients. Norgine’s approach and infrastructure is integrated and
focused upon ensuring that Norgine wins partnership opportunities
for growth. Norgine is headquartered in the Netherlands and its
global operations are based in Amsterdam and in Harefield, UK.
Norgine owns an R&D site in Hengoed, Wales and two
manufacturing sites, one in Hengoed, Wales and one in Dreux,
France. For more information, please visit www.norgine.com. In
2012, Norgine established a complementary business Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more
information, please visit www.norgineventures.com.
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 BiopharmaceuticalsBrent Larson,
614-822-2330Executive VP & CFOorSharon Correia,
978-655-2686Associate Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Sep 2023 to Sep 2024