Navidea Enters Exclusive License and Distribution Agreement For India with Sayre Therapeutics

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Tc 99m Tilmanocept Already Commercialized in Three Major European Countries

Represents Next-Generation Standard of Diagnosis For Sentinel Lymph Node Detection

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea”), a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics, today announced that it has entered into an exclusive license and distribution agreement (the “License Agreement”) with Sayre Therapeutics for the development and commercialization of Tc 99m tilmanocept in India. Sayre Therapeutics specializes in innovative treatments and medical devices commercialization in South Asia.

Under the terms of the agreement, Navidea received an upfront payment and is eligible to receive upcoming milestone payments and double-digit royalties associated with the sale of Tc 99m tilmanocept in India.

Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, stated, “We view this partnership as an important milestone in the expansion of tilmanocept’s adoption globally and reiterates our commitment to patients the world over. The terms of our agreement with Sayre are favorable and the increased economics will drive further revenues to fund our other pipeline assets.”

About Tc 99m Tilmanocept

Tc 99m tilmanocept 50 microgram kit for radiopharmaceutical preparation is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc 99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer.

About Sayre Therapeutics

Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology. Companies with novel Oncology and Immunology assets can work with us in South Asia, as we focus on alleviating life-threatening diseases with high unmet need.

About Navidea Biopharmaceuticals

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its ManoceptTM platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc 99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

For more information, please visit www.navidea.com.

Navidea Biopharmaceuticals
Jed Latkin, CFO/COO, 614-551-3416
jlatkin@navidea.com
or
Edison Advisors
Tirth Patel, 646-653-7035
tpatel@edisongroup.com

Source: Navidea Biopharmaceuticals, Inc.

Released June 20, 2017