Navidea Biopharmaceuticals has signed a distribution agreement for Lymphoseek injection in Taiwan with Global Medical Solutions Taiwan (GMST).
The companies will work together to address all needed Taiwanese food and drug regulatory requirements and expect local approval in 2014-2015.
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Lymphoseek injection (technetium-99m tilmanocept) for sentinel lymph node detection in head and neck cancer. Lymphoseek was approved by the FDA in March 2013 for use in lymphatic mapping procedures that help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
Navidea intends to file the supplemental new drug application for Lymphoseek.
The contract with GMST follows an agreement recently signed for Lymphoseek distribution in Canada, according to the company. Navidea has also recently started shipping Lymphoseek to medical centers in the Middle East. These market expansion activities build on the growth of Lymphoseek sales in the U.S.
