TAIPEI, Taiwan – Taiwan's biopharma industry faces strong competition from both China and South Korea, but its geographic position on the edge of Southeast Asia provides an advantage in marketing a potential dengue vaccine to the young and fast-growing region.

TAIPEI, Taiwan – Taiwan's biopharma industry faces strong competition from both China and South Korea, but its geographic position on the edge of Southeast Asia provides an advantage in marketing a potential dengue vaccine to the young and fast-growing region.

Straddling the Tropic of Cancer, Taiwan has also learned that the threat posed by dengue could get worse as global warming expands the zone in which infection is a risk. Speaking at the Biobusiness Asia Conference, part of BioTaiwan 2017, Meei-Yun Lin of Taiwan-based Medigen Vaccine Biologics Corp. (MVC) highlighted progress – and the urgency – relative to vaccine development.

The unexpected dengue fever epidemic in the south of Taiwan in the second half of 2015 resulted in more than 200 deaths and 40,000 cases. Lin's presentation, "Fighting the World's Most Neglected Tropical Disease," highlighted the danger of dengue fever in tropical areas, primarily Southeast Asia and Brazil, but it also put a focus on the opportunity presented by addressing this long-overlooked disease.

More than 2.5 million people are vulnerable to dengue fever worldwide, with 390 million infections and 25,000 deaths each year. With an eye on addressing dengue both at home and in neighboring countries, MVC signed a license agreement with the U.S. National Institutes of Health last November for the NIH's dengue fever vaccine.

To date, the vaccine has been the subject of 12 clinical trials, she said, eliciting "good protection" against all four dengue serotypes. "It is important to develop a vaccine to protect people from different dengue serotypes simultaneously," she said.

The vaccine was developed in Stephen Whitehead's laboratory in NIH's National Institute of Allergy and Infectious Diseases and was licensed to other institutions, including Butantan Institute in Brazil and Merck in North America and Europe.

According to the terms of the license agreement, MVC is allowed to conduct research and development, manufacturing, sales and sub-licensing of the NIH vaccine in 17 countries and areas including Taiwan, Southeast Asia and the Middle East.

"We want to make Taiwan a world player" in the vaccine space, Lin said.

The Taiwanese government and its Southeast Asian counterparts are willing to spend more on health care than ever before, Lin said. The appeal of vaccines, she said, is that they are an investment in saving money down the road.

"Investing $1 in disease prevention through vaccination can save $16 in disease treatment and socioeconomic costs for every preventable infectious disease," she said.

The vaccine market is set for rapid growth, she added, with a projected compound annual growth rate of 11.8 percent between 2016 and 2021. Several factors are driving this growth, including the prevalence of infectious diseases such as dengue fever, increased overall procurement, more medical spending in emerging markets and increased investment from companies.

MVC is preparing to initiate BSE/phase II trials in Taiwan, in which it will evaluate the efficacy of the NIH vaccine in the elderly. During the epidemic of 2015, Taiwan's Center for Disease Control noted that among the 209 patients who died, the median age was 75. It also found that the majority of fatalities also suffered from an average of three chronic conditions as well.

Taiwan's situation with regard to dengue fever cases is different from other countries, said Alain Bouckenooghe, associate vice president and regional head of clinical R&D for Asia Pacific at Sanofi Pasteur. Sanofi has also developed its own dengue fever vaccine. (See BioWorld Today, April 24, 2017.)

"Taiwan's situation is unique," Bouckenooghe said. "When we developed our vaccine originally, we focused on 11 countries. You're looking at younger people, you're looking at children." Sanofi intends to conduct more studies on older people in different countries in the near future, he said.

MVC is also preparing for simultaneous multi-nation and multi-site phase III trials, with a primary focus on Taiwan and Southeast Asia.

There is a slight yet significant political element to all of this, which Lin noted: President Tsai Ing-wen's New Southbound Policy, which aims at decreasing Taiwan's economic reliance on China in favor of greater diversification into Southeast Asian markets.

Lin said MVC's strategy for the region includes co-development of dengue vaccine with Southeast Asian countries followed by turnkey solutions, facilitating diplomacy through dengue fever vaccine supplies to Southeast Asia, providing affordable dengue fever vaccine to low- and middle-income countries and filling in the gaps in regional epidemic prevention.