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Navidea Provides Update on Lymphoseek® and Immunodiagnostics Development PipelineNavidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today provides an update on its commercial and clinical development efforts with respect to its Lymphoseek® (technetium Tc 99m tilmanocept) injection, the first and only FDA-approved receptor-targeted lymphatic mapping agent, and the Manocept™ immunodiagnostic development pipeline. 2015 Commercial Highlights In 2015, the Company created and executed a new commercialization strategy for Lymphoseek to better leverage the label expansion approved by the FDA in October 2014 and, over time, accelerate its market penetration. This included a complete refresh of the brand, moving away from a feature-based selling approach to a customer-centric one focused on the benefits to the surgeon and patient. In concert with the rebranding efforts, the Company also recruited, hired and trained a new salesforce in the latter part of the second quarter of 2015. The new direct sales team focused on targeting the highest priority territories. The Company anticipated the sales team's contributions would be most significant starting the fourth quarter of 2015 and onward based on the four- to six-month sales cycle of Lymphoseek. The initial launch of the new commercialization strategy resulted in the following during 2015:
Rick Gonzalez, President and Chief Executive Officer, said, "We enter 2016 with positive momentum behind our new commercialization strategy. We expect our sales team's strong contributions to continue to accelerate product revenues throughout the year. In addition, European sales revenues are expected to be generated from commercialization efforts to begin in the fourth quarter. In parallel, our R&D team is aggressively advancing our immunodiagnostics pipeline focused on significantly larger market opportunities including Rheumatoid Arthritis (RA), which has a prevalence of approximately 3.8 million patients in the U.S. and Europe. We will share additional details on our plans for 2016, including an update on Macrophage Therapeutics and the sale of NAV4694, during our upcoming year-end earnings conference call." Clinical Development Update The Company continues to work toward a more focused development program using its Manocept platform in immunodiagnostics, including the FDA label expansion for Lymphoseek (Tc99m tilmanocept) into RA and Kaposi's sarcoma (KS). Importantly, the costs of these development programs will be defrayed by NIH grants awarded to the Company in 2015 totaling over $3.8 million. In the next 90 days, the Company intends to:
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. 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 solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity. Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety Information
Important Safety Information
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About Navidea 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. View source version on businesswire.com: http://www.businesswire.com/news/home/20160202006665/en/ |