Liposomes, the microsocopic lipid vesicles that scientists have been making in great variety, are rapidly entering clinical medicine and are expected to improve how many diseases are treated. The Taiwan Liposome Company specializes in developing liposomes to improve how drugs are delivered. While we here at Medgadget normally don’t cover pharmaceuticals, anything that’s engineered at the nanoscale should interest our audience and we wanted to ask one of the commercial leaders in this field a bit about the industry. George Yeh is the President of Taiwan Liposome Company (TLC) and we thank him for fielding our questions.
Medgadget: Your firm specializes in a very narrow and interesting field. Can you please give us an overview of the applications of liposomes in medicine and where you see this field heading.
George Yeh, Taiwan Liposome Company: Liposomes and related lipid-based technologies are particularly useful in two areas of drug delivery: making more targeted therapies or providing more sustained release of a drug over time. Improving on the properties of current medicines is a straightforward concept, but tapping into key markets where lipid-based nanomedicines will make the greatest impact requires specialized expertise.
In areas like ophthalmology or osteoarthritis, avoiding frequent injections by making medicines last longer is a major advantage of our technology. In oncology, lipid-based nanotechnologies have helped address the two most common problems in the development of new chemotherapies: high toxicity and low solubility. We are also beginning to design drugs that use lipid-based nanotechnology not only to target delivery to specific tissues, but also to target particular areas within a given cell in that specific tissue. For certain indications, better targeting of delivery has the potential to reduce side effects and may improve efficacy as well.
Medgadget: What are some of the more exciting advancements TLC has developed?
George Yeh: Currently available drugs for osteoarthritis have a short duration of action, leaving many patients in pain for long periods of time in between treatments. Our product TLC599 uses proprietary BioSeizer™ nanotechnology to encapsulate a steroid, allowing for the steroid to be released at a constant dose over time and provide pain relief for up to three months. This effect bridges the gap between treatments and should provide safe pain relief year-round. A Phase 1/2 clinical trial of TLC599 has recently completed enrollment and results are expected in the second half of 2016.
In the treatment of macular edema, a common disease that can lead to blindness, patients are typically treated with inconvenient and unpleasant injections into the eye every one or two months. Our sustained release treatment TLC399 is designed to be effective for over six months, dramatically decreasing the frequency of injections. A Phase 1/2 clinical trial of TLC399 will start recruiting in the US before the end of 2016.
Sustained release therapies not only help patients but can also decrease the number of visits to a clinic for treatment. Because these visits are often a very expensive part of overall care, sustained release therapies have the potential to significantly reduce costs to the healthcare system.
Medgadget: Who are your customers and how do you work with them on creating new products?
George Yeh: TLC has a unique market niche, working closely with global biopharmaceutical companies at multiple stages of product development. As downstream distributors of our products, they are our primary customers. We work together to share knowledge and identify market opportunities that are a fit for our unique technology and scale-up expertise. In turn, these biopharmaceutical companies, such as Teva and Sandoz (a subsidiary of Novartis), bring the products we develop to global networks of physicians and health care providers.
Medgadget: Does operating from Taiwan help your business and what are some of the challenges of introducing your products in different world markets?
George Yeh: Taiwan is a great place for biopharma companies in early stages of development and the Taiwanese biotechnology sector is poised for growth. There have been quite a number of biotech IPOs in Taiwan, partly because the financial regulators in Taiwan provide a unique review and approval mechanism for companies not yet profitable to be publicly listed. This is true in the US as well, but is not the case for Hong Kong and Singapore. This special route is particularly helpful for biotech companies because it allows them to raise funds for R&D and clinical trials before products enter the market.
Another benefit in operating from Taiwan is that the political leadership has had experience in actually working in the healthcare industry before coming to power, so they are able to develop policies that support this sector of the economy. In addition, the unique relationship between Taiwan and mainland China contributes to its growing biotechnology sector. Agreements with Chinese regulators allow for clinical data collected at specific sites in Taiwan to be used for submission for regulatory approval. This is not the case for data from studies conducted in the US or Europe and makes Taiwan a distinctive gateway to an extremely large market.
However, because regulations for biopharmaceutical products vary quite a bit across different regions, operating from Taiwan means we need help from individuals experienced in drug development in specific markets worldwide. While we currently depend on local help, we are hoping to attract talent from across the globe to come work in Taiwan and help address this challenge.
Medgadget: What competitive advantage does your company have over your competitors?
George Yeh: In addition to our patented and adaptable nanoparticle technology platforms and our advantages in gaining access to the mainland China market we owe a lot of our success to strategic planning. We plan ahead carefully in evaluating a path to regulatory approval. For example, our general approach is usually to initiate clinical trials in Taiwan first to obtain pilot results at a lower cost and then we take trials to a larger scale in both Taiwan and one or more additional major markets such as the US or Europe.
Also, we plan for commercial scale production from early stages of product development to allow a low total cost of goods. Competitors that failed to consider production earlier on tend to have more complicated manufacturing practices, leading to higher costs and potentially lower profit margins.
Link: Taiwan Liposome Company…