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."
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