Cross-country deals, new drug trials gain momentum in Asia

Print 17 May 2016
Richard Smart / BioWorld

TOKYO – George Yeh, president of Taiwan Liposome Co. Inc. (TLC), told BioWorld Asia that in the coming years more trials for new drugs would take place in Asia, and that cross-country collaborations will help train a new generation of doctors in how to detect the potency and effectivity of treatments yet to reach the market.

During a visit to Tokyo, Yeh pointed out that multiple collaborations are now taking place across Asian countries, and between countries from the continent and the U.S. He said that these collaborations were in their early stages but would eventually bear fruit.

“Asia still has some years to catch up, not in terms of care for patients, but in terms of experience in understanding effects that are drug-related or not” in trials, Yeh said. “These judgments will determine where the research goes.

“Our experience is that in earlier, exploratory stages, especially in areas such as oncology, these patients have often run out of options, and you start to see all sorts of effects, some of which are not drug-related. And you see doctors starting to build up experience,” he added.

He pointed out that despite the relative lack of experience in Asia, things were improving, particularly as China began to push forward with reforms of its health care sector. “Last year, we had four hospitals in Taiwan and four in China mutually recognized for doing trials. That can work as a base and we can then build up the foundations. There will be a lot of advantages to working together. If you think of drugs in their early phases, they require a lot of clinical trials, and Taiwan is a perfect fit because of the skills there. Once you start to do certain clinical progress on cancer, China would be a place where you would really see skills rise.”

Naoaki Shimizu, of Otsuka Pharmaceuticals’ clinical development department, expressed a similar sentiment at the DIA New Drug Conference last month. He said that when his company did trials in the Philippines for aripiprazole, a drug for mental illnesses such as schizophrenia and bipolar disorder, there were reasons to take more care over results than in other countries.

“Compared to other countries, the enrollment is much faster in the Philippines,” Shimizu said. “And when we spoke to patients, they were really happy to have access to original drugs. And compared to Japan, some poor countries are just happy to be involved in studies and patients are glad to be involved in the study. But that can be a risk as it increases placebo effects in studies.”

For Yeh, there is not much to be done about the issues other than wait for doctors to get more experience. He pointed out that some countries are now working more closely with the U.S. to build up the necessary experience.

“Some physicians in Taiwan and also in China are sent to phase I centers in the U.S.,” he said. “One program, [the] START [Center for Cancer Care] in San Antonio focuses on oncology phase I and it set up satellites in Taiwan and China. They have been sending physicians back and forth. There are a lot of links already, and as biotech companies start testing more products, they will build up much richer experience and stronger foundations.”

Increasing skills across Asia will have advantages over just being able to transfer development to the continent. Certain diseases, such as liver cancer, tend to affect a disproportionate number of Asians and so are overlooked by the major pharmaceutical companies, which are more focused on diseases that are widespread in the U.S. and EU countries.

“Asia is a place where people come after developing in the U.S. or Europe,” Yeh said. “But if we think about how much disease cannot be treated, particularly Asian diseases, and about the meaning of drug development, it is finding treatment for Asian populations. At least that is one of the missions for TLC.”

Among the drugs under development for TLC is Lipotecan, which targets liver cancer. The treatment, which has orphan drug status in the U.S. and Europe, is on the Green Path fast track for development in China.

TLC so far has two drugs on the market, Ambil, a liposomal formulation of amphotericin B for the treatment of fungal infection, and Proflow, a lipid emulsion-based reformulation of prostaglandin E1 for peripheral arterial disease. The company works with Teva Pharmaceutical Industries Ltd. and Sandoz, a division of Novartis AG, which market the drugs.

The Taiwanese biopharma company also set up its Japan subsidiary in Tokyo last January.

“We are about 150 people, all focused on product and technology development,” Yeh said. “We do not do sales, even in Taiwan. Commercial sales is a totally different type of game plan. Depending on our partners and the biostructures, we handle everything up to products being ready for submission. But we do want to engage partners earlier, so that at least we can bring in key opinion leaders from the initial stages of development.”

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