|TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Taiwan Liposome Company, Ltd. (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in pain management, ophthalmology and oncology, today announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma. Soft tissue sarcomas are cancers of the body’s connective or supportive tissues, such as cartilage, fat, muscle, fibrous tissue, and blood vessels. TLC178 is a liposomal formulation of vinorelbine, a vinca alkaloid chemotherapy agent. A Phase I/II, open-label, multicenter, dose escalation clinical trial is currently underway to evaluate the maximum tolerated dose of TLC178 in adults with advanced malignancies; to date, no dose limiting toxicity has been reported.
“We are pleased to have received orphan drug designation for TLC178 from the EMA. This European designation, along with our previously granted orphan designation in the U.S., will enable our global development strategies for TLC178 to find a new treatment option to address the unmet needs in soft tissue sarcoma worldwide,” said TLC President George Yeh.
Orphan drug designation by the EMA provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment is available. The designation provides incentives for companies seeking protocol assistance and scientific advice from the EMA during the product development phase and a 10-year period of marketing exclusivity in the EU following product approval.
TLC178 is TLC’s proprietary NanoX liposomal formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma. TLC178 is designed to increase the therapeutic index and reduce side-effects through prolonged circulation time and increased accumulation of vinorelbine in tumor tissues, with the potential to decrease toxicity, improve tolerability and increase durable response rates. In April 2017, the U.S. Food and Drug Administration (FDA) granted TLC178 a Rare Pediatric Disease Designation in RMS, which will qualify TLC178 in this indication for priority review in the U.S., and may result in the granting of a transferable Priority Review Voucher that can shorten the FDA’s marketing application review time to six months. In July 2017, the FDA also granted TLC178 an Orphan Drug Designation for the treatment of soft tissue sarcoma, which can provide marketing exclusivity for seven years.
TLC (Nasdaq: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of 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, and improve active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX active drug loading technology is designed to alter the systemic exposure of the drug, potentially reducing dosing frequency and enhancing 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC178, the clinical benefits of TLC178 for people with soft tissue sarcoma, and the timing, scope, progress and outcome of the Phase I/II clinical trial for TLC178 and TLC’s global strategy for its drug development and anticipated benefits from receiving orphan designations. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of risks, assumptions, uncertainties and factors, including risks that the outcome of any clinical trial is inherently uncertain and TLC178 or any of our other product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval. Other risks are described in the Risk Factors section of TLC’s prospectus dated November 21, 2018 filed pursuant to Rule 424(b)(4) with the U.S. Securities and Exchange Commission. All forward-looking statements are based on TLC’s expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.