AnGes is pleased to announce that the Center for Biologics Evaluation and Research's (CBER) Advertising and Promotional Labeling Branch (APLB) has concluded that the proprietary name, COLLATEGENE®, is acceptable at this time. A request for re-review will be included along with the upcoming Biologics License Application (BLA) submission.
Further, the U.S. Patent and Trademark Office (USPTO) has accepted AnGes' registered trademark maintenance request for COLLATEGENE®, maintaining the registration status.
The United States Adopted Names (USAN) Council adopted the non-proprietary name, beperminogene perplasmid.
As a result of the above confirmations, AnGes will be able to use the names "COLLATEGENE®" and "beperminogene perplasmid" in its upcoming Biologics License Application (BLA).
*About the HGF Gene Therapy Product
The HGF gene therapy product is a plasmid DNA that expresses hepatocyte growth factor (HGF), which was originally discovered in the liver, the organ with the highest regenerative capacity. When administered to ischemic tissue, the product induces the production and secretion of HGF, promotes the development of collateral blood vessels at the ischemic site, increases local blood flow, and thereby improves ischemic conditions.
HGF plays a major role not only in the liver but also in the formation and regeneration of various organs and tissues throughout the body, including blood vessels, lymphatic vessels, and nerves. Focusing on HGF's ability to induce angiogenesis, the Company has developed this product as a novel therapeutic agent for ischemic diseases caused by vascular occlusion and reduced blood flow, offering a novel mechanism of action through the promotion of new blood vessel formation, and has brought it to commercialization.
(Note)This document has been translated from the Japanese original for reference purposes only.
In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.