- Only 1% of drugs injected into the body reach their target sites.
- Taiwan Liposome Co.'s technology prolongs a drug's effectiveness and reduces its toxicity to the body.
- The Taiwan-listed company aims to improve drugs that are already approved but being used for other diseases off-label.
Taiwan Liposome Co. Ltd., or TLC, is a biopharmaceutical company developing lipid-based medicines for pain management and ophthalmology using its nanotechnology drug delivery system. The Taiwan-listed company is looking to apply its technology to other treatments that are already available in the market but being used to address off-label conditions. In January, TLC formed a joint venture with China-based Jixi Biotechnology Partners to develop and commercialize its pipeline products for the China market, and in February filed plans to launch an IPO in the U.S.
George Yeh, president of TLC, spoke to S&P Global Market Intelligence about listing on the Nasdaq, developing its nanotechnology, and tackling a rare disease drug. The conversation has been edited and condensed for brevity and clarity.
S&P Global Market Intelligence: Why IPO on the Nasdaq and how is it different from Taiwan?
George Yeh: Most of our clinical trials have been conducted in the U.S. and they are entering a late stage now. Within a few years, our products may launch in the U.S. so it's the right time to gain better exposure. It will make it easier for physicians to run the trials and also for patients to be prescribed the products. In the U.S., you can file the required documents on a confidential basis with the SEC for review. But in Taiwan, the whole process is more public, which may sometimes hurt the stock as the market may speculate over the ongoing dialogue with the regulator.
What is TLC's nanotechnology?
We have two main drug delivery technologies. BioSeizer is a sustained-release technology which improves a medicine's effectiveness. Unlike free drugs which roam around the target site, BioSeizer entraps the drug molecule in layers of lipids — fat-like substances. As the lipid layers break down and slowly release the drug over time, it prolongs the effect of the drug at the site.
Our other technology, NanoX, encapsulates and protects the drug as it is delivered to its target site, reducing its toxicity to the body. It has worked extremely well with cancer medications. Blood vessels near tumors tend to grow rapidly and leak, with openings typically between 400 to 900 nanometers. Since NanoX is about 80 to 100 nanometers, it is easy for the medicine to move into the tumor. But if you injected the medicine into the body without the NanoX technology, there is a very high chance it will not reach the target. Just about 1% of free drugs reach their target sites. With NanoX, you're able to get up to 8% to 10%, roughly a ten-fold increase in drug delivery.
What type of drugs can use TLC's drug delivery system?
We are applying our technologies to injectable drugs that are already in the market. We have a compound library of more than 50 approved drugs that are no longer under patent, or about to become off-patent that can fit into these systems. We know these medicines work but what we're trying to improve is the duration. If you can improve its duration from a few weeks to three months or even six months for a single shot, basically it will reduce the number of hospital visits and dose frequencies for patients.
Can you tell me about developing a rare disease drug like TLC178?
Vinorelbine is approved for treating non-small cell lung cancer and breast cancer but it is also used off-label — meaning for a disease that it did not get the regulatory approval for — to treat a rare type of cancer found in children called rhabdomyosarcoma. There are about 350 cases of this disease reported in the U.S. annually. We know the drug works so we wanted to resolve two issues — toxicity and dose frequency. If you treat these kids with free vinorelbine, their blood toxicity reaches about 70%, which greatly damages their body. They also need to get weekly injections for about six months. But with our technology, we can give one injection every month instead, and based on eight patients so far, none of them have shown signs of toxicity. We have already entered discussions with the U.S. Food and Drug Administration to start a trial in the first half of 2018.
When do you expect your products to launch in the U.S.?
We have three products at the clinical development stage. They are TLC599 for osteoarthritis pain; TLC399, which treats fluid build-up in the eye; and TLC178, which treats rhabdomyosarcoma. There is one more product, TLC590, which treats post-surgical pain, for which we will be initiating our early stage clinical trial in the first half of 2018. Since the duration of this trial is much shorter, by the end of 2019, all four of our products will be in the pivotal trial stage of development. We expect our products to reach the market from 2021 onward.