Navidea’s Commercial Partner, Norgine B.V., Launches LYMPHOSEEK® in Europe
June 12 2017 - 11:06AM
Business Wire
LYMPHOSEEK® Represents Next-Generation Standard
of Diagnosis For Sentinel Lymph Node Detection
LYMPHOSEEK® Commercialized in Three Major
European Countries
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea”), a
company focused on the development and commercialization of
precision immunodiagnostic agents and immunotherapeutics, today
announced that its European commercial partner, SpePharm AG, an
affiliate of Norgine, B.V., launched LYMPHOSEEK® (technetium TC 99m
tilmanocept), originally developed by Navidea, in Denmark, the
Netherlands and the UK.
Navidea entered into an exclusive sublicense agreement with
SpePharm, in exchange Navidea received an upfront payment,
milestone payments and will receive royalties on all European net
sales. The territory covered by the agreement includes all 28
member states of the European Economic Union.
LYMPHOSEEK® is specifically designed to target, bind to and be
retained in sentinel lymph nodes, the first lymph node (or group of
nodes) to which cancer cells are most likely to spread from a
primary tumour. LYMPHOSEEK® has a false negative rate of 2.6% in
T1-T4cN0 oral squamous cell carcinoma (OSCC). It detected sentinel
lymph nodes in 98% of patients with Tis, Tx or T1-T4cN0 breast
cancer and T1-T4cN0 melanoma.
Michael Goldberg, M.D., President and Chief Executive Officer of
Navidea, stated, “The commercial launch of tilmanocept is an
important revenue provider for Navidea through royalties that boost
our ability to progress our Manocept™ platform further not only in
diagnostic utility but also advancing therapeutics development. I
applaud Norgine in launching tilmanocept’s successful
commercialization in three European countries. We also look forward
to bringing additional value to our shareholders, and to patients,
as Norgine strategizes expanding its commercial launch into the
remaining European Union countries.”
Europe represents a major growth opportunity and medical need
due to LYMPHOSEEK®’s ability to identify lymphatic drainage from
tumors in the floor of the mouth (underneath the tongue). Currently
up to 70-80% of patients with early oral cancer receive elective
neck dissection surgery, an expensive procedure which could be
avoided by using sentinel lymph node biopsy (SLNB) for staging. In
major European markets, 76,917 new cases of head and neck cancer
diagnosed in 2014. The European nuclear
medicine/radiopharmaceuticals market is expected to reach $1.62
billion by 2020 from $1.09 billion in 2015, growing at a CAGR of
8.2% from 2015 to 2020.
About LYMPHOSEEK®
LYMPHOSEEK® 50 microgram kit for radiopharmaceutical preparation
is approved in Europe 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.2 External imaging and intraoperative evaluation
may be performed using a gamma detection device.2 LYMPHOSEEK® is
designed for the precise identification of lymph nodes that drain
from a primary tumor, which have the highest probability of
harboring cancer.
Important Safety Information
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%).
Please see full Prescribing Information on www.lymphoseek.com
for more information.
About Sentinel lymph node biopsy
Sentinel lymph node biopsy (SLNB) is a diagnostic procedure
which involves surgical removal of the first lymph node or group of
nodes (the sentinel node) which drain directly from the primary
cancer site. It is a surgical procedure which requires an overnight
stay in hospital and usually has no significant morbidity attached
to it.
About Norgine B.V.
Norgine is a leading European specialist pharmaceutical company
with a direct commercial presence in all major European markets. In
2016, Norgine’s total revenue was EUR 368 million. Norgine employs
over 1,000 people across its commercial, development and
manufacturing operations and manages all aspects of product
development, production, marketing, sale and supply. Norgine
specialises in gastroenterology, hepatology, cancer and supportive
care.
Norgine is headquartered in the Netherlands. Norgine owns a
R&D site in Hengoed, Wales and two manufacturing sites in
Hengoed, Wales and Dreux, France.
About Navidea Biopharmaceuticals
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 based on its ManoceptTM 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 Tc 99m
tilmanocept, the first product developed and commercialized by
Navidea based on the platform. The development activities of the
Manocept immunotherapeutic platform are being conducted by Navidea
in conjunction with its subsidiary, Macrophage Therapeutics, Inc.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170612005826/en/
Navidea BiopharmaceuticalsJed Latkin, CFO/COO,
614-551-3416jlatkin@navidea.comorEdison AdvisorsTirth Patel,
646-653-7035tpatel@edisongroup.com
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Feb 2024 to Mar 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Mar 2023 to Mar 2024