Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) has entered an
exclusive agreement with a wholly-owned subsidiary of Hainan
Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organization
with a broad China focus in oncology and other therapeutic areas,
who will develop and commercialize Lymphoseek® (technetium Tc 99m
tilmanocept) Injection in China. In exchange, Navidea will earn
revenue based on unit sales to Sinotau, a royalty based on
Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones
from Sinotau, including a $300,000 upfront payment. Lymphoseek is a
novel, receptor-targeted, small-molecule radiopharmaceutical
approved in the U.S. for use in lymphatic mapping to assist in the
detection of lymph nodes in patients with breast cancer or melanoma
and for use in guiding sentinel lymph node biopsy in certain oral
cancer patients.
As part of the agreement, Sinotau is responsible for costs and
conduct of clinical studies and regulatory applications to obtain
Lymphoseek approval by the China Food and Drug Administration
(CFDA). Upon approval, Sinotau will be responsible for all
Lymphoseek sales, marketing, market access and medical affairs
activities in China and excluding Hong Kong, Macau and Taiwan.
Navidea and Sinotau will jointly support certain pre-market
planning activities with a joint commitment on clinical and market
development programs pending CFDA approval. In addition to the
$300,000 upfront, Navidea is eligible for $700,000 in milestones up
to and through product approval, and an additional $1.5 million in
sales milestones.
“This agreement is part of our goal to make Lymphoseek available
to as many physicians and cancer patients around the world as
quickly and effectively as possible,” said Thomas Tulip, Ph.D.,
President and Chief Business Officer of Navidea. “We
selected Sinotau as a partner in China given their success in
developing and filing for market approvals on more than 20 drugs,
their pharmaceutical sales and marketing experience, and their
established relationships with hospitals and clinicians throughout
China.”
“Our partnership combines Navidea’s expertise in
radiopharmaceuticals, clinical development and manufacturing with
our extensive development, regulatory, sales, and marketing
capabilities,” commented Xu Xinsheng, Sinotau President and CEO.
“The goal will be to offer a novel radiopharmaceutical to
potentially spare patients from unnecessary surgery and which can
play a critical role in staging and directing cancer treatment. We
look forward to giving physicians this new tool in the fight
against the many types of cancers common in China, such as breast,
oral, and gastric cancers and contributing to bettering the lives
of those afflicted with these conditions."
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 with breast cancer, melanoma and head and neck cancer
patients with oral cavity carcinoma. 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 lymphatic mapping to assist in the localization of
lymph nodes draining a primary tumor in patients with breast cancer
or melanoma and for use in guiding sentinel lymph node biopsy in
head and neck cancer patients with squamous cell carcinoma of the
oral cavity. The Company anticipates continuing development of
Lymphoseek into other solid tumor areas.
Lymphoseek Indication and Important Safety
InformationLymphoseek (technetium Tc 99m tilmanocept) Injection
is indicated, using a hand-held gamma counter, for:
- Lymphatic mapping to assist in the
localization of lymph nodes draining a primary tumor site in
patients with breast cancer or melanoma;
- Guiding sentinel lymph node biopsy, in
patients with clinically node negative squamous cell carcinoma
(SCC) of the oral cavity.
Important Safety InformationIn 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%).
Full Lymphoseek Prescribing Information Can Be Found at:
WWW.LYMPHOSEEK.COM
About Navidea Biopharmaceuticals Inc.Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of
precision diagnostics and radiopharmaceutical agents. Navidea is
developing multiple precision diagnostic products and platforms
including Manocept™, NAV4694, NAV5001, and NAV1800 (RIGScan™), to
help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making 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. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and advancing
the Company’s pipeline through selective acquisitions, global
partnering and commercialization efforts. For more information,
please visit www.navidea.com.
About Hainan Sinotau Pharmaceutical Co., Ltd.Hainan
Sinotau Pharmaceutical Co., Ltd. is a pharmaceutical company
focused on the registration and commercialization of imported and
domestic generic formulations in the mainland China market. Hainan
Sinotau commenced operations in 2002 with the purpose of providing
access to quality medicines to patients across China; it has
experienced strong growth throughout its lifespan with coverage of
all of the mainland Chinese market. Hainan Sinotau’s strategic
focus lies in developing a product portfolio centered on Oncology,
Antiretroviral, Central Nervous System and Cardiovascular System
therapies in partnership with leading multinational pharmaceutical
firms.
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, Executive VP & CFO,
614-822-2330orSharon Correia, Associate Director, Corporate
Communications, 978-655-2686
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