Taiwan Liposome Co (TLC, 台灣微脂體) is seeking streamlined US regulatory approval for its efforts in treating pediatric rhabdomyosarcoma, a rare disorder affecting about 350 children in Taiwan.
TLC, which developed a proprietary lipid-assembled delivery platform for nanomedicine injections, is looking to qualify for the US Food and Drug Administration’s (FDA) Rare Pediatric Disease Priority Review Voucher program that provides incentives for sponsors that receive approval for biologics license applications.
The company’s technology traps the active pharmaceutical ingredient in multiple layers of lipids to promote fast-acting and sustained release of active pharmaceutical ingredients, as well as reducing the frequency of required injections.
The company’s treatments can also be administered with smaller-gauge needles, which provides broader use for physicians.
The voucher grants priority review of a subsequent marketing application for a different product and the treatment can be sold for more than US$100 million to other drug developers vying to beat rivals to the market, TLC president George Yeh (葉志鴻) said at an earnings conference in Taipei.
To earn the voucher, the company would start clinical trials for TLC178, its target-delivered nanomedicine for managing tumor growth, before the end of the first half of the year, Yeh said, adding that studies for rare diseases are single-armed.
In addition to TLC178, three other products are expected to enter the trial stage before the end of next year, Yeh said, adding that the firm’s lipid-based technology has produced favorable results in clinical trials.
TLC599, a sustained release therapy for the treatment of osteoarthritis pain, has shown minimal cartilage damage among patients while providing fast-acting as well as sustained pain relief, Yeh said.
TLC590, which brings sustained release delivery technology to the common local anesthetic ropivacaine, is designed as an alternative post-surgery pain management therapy to combat rising opioid addiction, he said.
Similarly, TLC399 provides sustained release for macular edema without the need to insert an implant in the eye, he added.
Overall, the US FDA has been very positive about alternatives for opioids in previous meetings with the company, Yeh said.
TLC’s pain management products are expected to be highly competitive in the US market as they can be produced in low-cost manufacturing environments, he said.
Regarding the company’s plans to list American depositary receipts (ADRs) on the NASDAQ, Yeh said that the move would help raise the company’s profile in the US, its biggest target market.
The issue price is expected to be more than NT$72 per ADR, the same level the company’s shares were trading at the time of application in November last year.
The company decided on an overseas listing because it is tougher to gain a higher valuation in Taiwan with its investment requirements, he added.
The company, which is still seeking market approval for its new drugs, posted net losses of NT$873 million (US$29.79 million) for last year.
Shares of TLC yesterday dipped 6.61 percent to NT$100.5 in Taipei trading.
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