TLC Announces Application with U.S. FDA for Proceeding of TLC590 as Investigational New Drug (IND)

TAIPEI, Taiwan, April 03, 2018 (GLOBE NEWSWIRE) -- Taiwan Liposome Company, Ltd. (4152.TWO) ("TLC"), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of medical need in pain management, ophthalmology, and oncology, today announced that it has applied with the U.S. Food and Drug Administration (FDA) for the proceeding of TLC590 as an Investigational New Drug (IND). The IND submission will be reviewed under the streamlined 505(b)(2) regulatory pathway. TLC590 is the company's proprietary BioSeizer-formulation of ropivacaine engineered to provide fast-acting and long-lasting non-opioid postsurgical pain relief. Pending the FDA acceptance of the IND, a first-in-human Phase I/II clinical trial will be initiated to assess the safety, tolerability, and pharmacokinetic profile of TLC590 in subjects undergoing hernia repair surgery in escalating dose cohorts compared to free, non-liposomal ropivacaine.

"We are delighted for this milestone and the advancement of another one of our programs into clinical trials," commented George Yeh, President at TLC. "This reflects the dedication that our team has put forth in research and development to find an alternative solution for post-surgical pain management. We have seen the introduction of opioids to patients after surgery leading to an unhealthy gateway to addiction, and we believe that TLC590, our sustained release non-opioid, non-addictive alternative, can be a promising solution."

About TLC590

TLC590 is a non-opioid BioSeizer formulation of ropivacaine, a common local anesthetic drug belonging to the amino amide group that was developed after bupivacaine. Ropivacaine has been found to have less cardiovascular and central nervous system toxicity compared to bupivacaine, the active drug in an extended release formulation currently available in the U.S. that demonstrated significant efficacy up to 24 hours post-surgery, but showed minimal to no efficacy between 24 and 72 hours after administration. TLC believes that TLC590's dense multilamellar structure is capable of providing high concentration drug loading and continuous release of the safer ropivacaine which, when administered into the surgical site, is intended to provide both immediate onset and extended pain relief of up to 72 hours. In preclinical studies, TLC590 displayed longer anesthetic effect than free ropivacaine, and earlier onset and longer anesthetic effect than extended release bupivacaine at equipotent dose.

About TLC

TLC (4152.TWO) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of best-in-class novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™). TLC believes that its deep experience with liposome science allows TLC to combine onset speed and benefit duration, while establishing drug levels at target tissues without incurring large systemic exposures. TLC's BioSeizer™ technology enables local sustained release of therapeutic agents at the site of disease or injury; its NanoX™ targeted delivery technology enables prolonged pharmacokinetic profiles and enhanced distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan's Corporate Governance Evaluations.