On April 18, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the regulatory approval of Lymphoaim ("Lymphoseek" in the rest of the world; Tc99m tilmanocept) by the Central Drugs Standard Control Organisation, India (Press release, Navidea Biopharmaceuticals, APR 18, 2022, View Source [SID1234612402]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Sayre Therapeutics will lead Lymphoaim commercialization efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specializes in innovative treatment and medical device commercialization in South Asia.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted that Lymphoaim has received regulatory approval in India and will be available to patients in need." Dr. Rosol continued, "This will also bring a new revenue stream to the Company to help us advance other pipeline products."

Mr. Shukrit Sudhir Chimote, Chief Executive Officer for Sayre, said, "Lymphoaim, a radioactive diagnostic agent, would benefit surgeons in guiding sentinel lymph node biopsies. This product fits well with Sayre’s mission of providing novel treatment solutions, and will certainly help boost our presence in the surgical oncology segment."