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®Lymphoseek ® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others. Lymphoseek was granted Fast Track designation in December 2013 for sentinel lymph node detection in patients with head and neck cancer. 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 IndicationLymphoseek (technetium Tc 99m tilmanocept) Injection is a lymphatic mapping agent indicated for use with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.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. The most common adverse reactions are injection site irritation and/or pain (<1%). FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM About Global Medical Solutions, Ltd.Global Medical Solutions, Ltd. was formed in 2003 to be a leading-edge provider of nuclear medicine and diagnostic imaging products and services. Global Medical Solutions' core businesses consist of the overseas units of the former Syncor International. A group of former top management of Syncor International created Global Medical Solutions and purchased the Syncor Overseas sites from Cardinal Health following the purchase of Syncor International by Cardinal Health. Global Medical Solutions' mission is to continue the long history of providing quality products and services to the worldwide nuclear medicine community. 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 NAV4694, NAV5001, Manocept™ and 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 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. 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.