UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) |
September 4, 2014 |
NAVIDEA BIOPHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
001-35076 |
31-1080091 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
5600 Blazer Parkway, Suite 200, Dublin, Ohio |
43017 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including area code |
(614) 793-7500 |
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On September 4, 2014, Navidea Biopharmaceuticals,
Inc. (the “Company”) issued a press release announcing an exclusive agreement with a wholly-owned subsidiary of Hainan
Sinotau Pharmaceutical Co., Ltd. A copy of the Company’s September 4, 2014, press release is furnished as Exhibit 99.1 to
this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
Exhibit |
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Number |
Exhibit Description |
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99.1 |
Navidea Biopharmaceuticals, Inc. press release dated September 4, 2014, entitled “Navidea Enters Lymphoseek Development and Commercialization Agreement for China.” |
Statements contained or incorporated by
reference in this Current Report on Form 8-K 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,
and markets for the Company’s products, are forward-looking statements. 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, 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, and other risks detailed in the Company’s most recent Annual Report on Form
10-K and other filings with the United States Securities and Exchange Commission. The Company undertakes no obligation to publicly
update or revise any forward-looking statements.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Navidea Biopharmaceuticals, Inc. |
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Date: September 10, 2014 |
By: |
/s/ Brent L. Larson |
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Brent L. Larson, Executive Vice President and
Chief Financial Officer
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Exhibit 99.1
FOR IMMEDIATE RELEASE
Navidea Enters Lymphoseek®
Development and Commercialization Agreement for China
DUBLIN OHIO September 4, 2014 --
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.
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NAVIDEA BIOPHARMACEUTICALS
Page | 2
Lymphoseek Indication and Important Safety Information
Lymphoseek (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 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%).
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.
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NAVIDEA BIOPHARMACEUTICALS
Page | 3
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.
Source:
Navidea Biopharmaceuticals, Inc.
Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
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