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Navidea Biopharmaceuticals Expands Lymphoseek® Global Commercialization EffortsDUBLIN, Ohio --(Business Wire)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today it has entered into a distribution agreement for Lymphoseek® (technetium Tc 99m tilmanocept) Injection in Taiwan with Global Medical Solutions Taiwan, Ltd. (GMST), a leading in-country distributor of nuclear medicine and diagnostic imaging products. The contract with GMST follows an agreement recently signed for Lymphoseek distribution in Canada, affording local access to that market as well. Navidea has also recently commenced shipment of Lymphoseek to select medical centers in the Middle East. These market expansion activities build on the growth of Lymphoseek sales in the United States, which continue the positive trends recently reported at the Company's Analyst Science Day on December 5, 2013. The Companies will work together to address all needed Taiwanese FDA regulatory requirements and expect local approval in 2014-15. Prior to complete regulatory approval, in appropriate situations, the product will be made available in accordance with named-patient mechanisms. The agreement anticipates distribution of non-radioactive kits as well as unit-dose product which will be radiolabelled at the GMST commercial radiopharmacy, affording flexibility in meeting the needs of end-users in the Taiwanese market. "We are pleased to have signed our first distribution agreement for Lymphoseek in Asia with GMST," said Dr. Thom Tulip, PhD, Navidea President and Chief Business Officer. "GMST provides important sales, marketing and distribution capabilities for Lymphoseek in the Taiwan market as well as providing the support needed to gain regulatory clearance in Taiwan. We believe Asia is a significant market for Lymphoseek, and Taiwan represents an important first presence as we introduce the product into the Asian communities. Building on our progress with US sales and our efforts in Europe and Canada, we continue to execute our plans to drive product commercialization and grow revenue around the world through the implementation of select distributorships such as our agreement with GMST." Dr. Mark Pykett, VMD, PhD, Navidea Chief Executive Officer, commented, "We believe providing the benefits of more accurate lymph node identification using Lymphoseek to cancer patients around the world is a key strategic objective of Navidea to advance our position as a leader in precision diagnostics. As we continue to grow the Lymphoseek franchise, we look forward to additional commercialization agreements for other countries and the ability to provide cancer patients better care on an increasingly global scale."
About Lymphoseek® Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to publicly available information, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013, with approximately 330,000 new cases of breast cancer, 69,000 new cases of melanoma and 95,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
U.S. Indication and Important Safety Information About Lymphoseek
Important Safety Information 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. The most common adverse reactions are injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
About Global Medical Solutions, Ltd.
About Navidea Biopharmaceuticals, Inc. 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.
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