India: Sayre Therapeutics with a portfolio of oncology and immunology focused commercial products, has entered into an exclusive license agreement with Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea”), a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutic, for the development and commercialization of Tc 99m tilmanocept in India.
The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S. Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014 under the brand name LYMPHOSEEK®. Tc 99m Tilmanocept is already commercialized in three major European Countries along with the US and represents Next-Generation Standard of Diagnosis for Sentinel Lymph Node Detection. Tc 99m Tilmanocept is approved for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity, or melanoma.
Shukrit Sudhir Chimote, CEO, Sayre Therapeutics, stated, “Our collaboration with Navidea is a testament to our efforts in introducing innovative cancer products to the Indian subcontinent. Sayre is committed to the access and availability of life-saving medicines in South Asia, to benefit the patient community and improve their quality of life.”
Praveen Bose, Senior Vice-President, Sales & Marketing, Sayre Therapeutics, stated, “Cancer of the breast affects approximately 155,000 patients in India every year. Tc 99m tilmanocept, the only targeted radio-diagnostic will be a welcome addition to the current armamentarium. In an US study of 31 patients, Tc 99m tilmanocept exhibited high specificity for identification of cancer affected lymph nodes, ensuring accurate staging and treatment of patients. In another study of 148 patients, Tc 99m tilmanocept identified more cancer affected lymph nodes per patient than conventional method of staining with vital blue dye. This targeted detection of higher number of lymph nodes, ensures precise staging of disease and appropriate therapy of patients. Cancer of the head and neck is a dreaded disease in India affecting approximately 160,000 patients every year. Currently Elective Neck Dissection (END) is the gold standard for assessment of spread of tumor to lymph nodes in patients with head and neck cancer. In a study of 101 head and neck cancer patients in the US, Tc 99m tilmanocept provided a high Negative Predictive Value (NPV), identifying correctly the lymph nodes that were free of cancer. This means, Tc 99m tilmanocept can be used to assess cancer spread in head and neck cancer patients, sparing the potential morbidity associated with END and offer better QOL (Quality of Life) to these patients.”
