June 1, 2012 (Vol. 32, No. 11)

Governments Increasingly Seek to Build Their Economies through Life Science Investments

In April 2011, Ascletis launched with $100 million in backing from a Chinese billionaire to discover and develop new treatments for cancer and infectious diseases in China. The company’s management team, based in Chapel Hill, NC, is made up of seasoned pharmaceutical industry veterans, but most of its staff is based in the company’s Hangzhou, China, offices.

Ascletis is not the first company attempting to marry U.S. expertise in drug development with affordable talent in China. But the company hopes to seize opportunities created by cultural differences between the two countries that may allow it to in-license promising products that have been shelved by pharmaceutical companies because they were seen as undesirable products for developed markets.

For example, Americans want once-a-day pills instead of injections, whereas people in China are more concerned about pricing, efficacy, and safety rather than convenience.

Ascletis reflects not only the new global marketplace—single, flat, interconnected, and increasingly borderless—but the opportunity life science companies have today to exploit the availability of capital and the differing value assets from one country to another.

It also points to a harsher reality of which the pharmaceutical industry has taken note. After decades in which the U.S., Europe, and Japan were the principal drivers of global economic growth, the tide has shifted to developing nations in Asia, Latin America, and other parts of the world where a rising middle class is fueling an economic boom.

These emerging markets—China, India, Brazil, Russia, South Korea, Indonesia, and Turkey, among others—are becoming the new economic heavyweights. China surpassed Japan as the world’s second-largest economy in 2011 and is projected to overtake the U.S. by 2020. India is expected to become the third largest economy within the next couple of years. And Brazil and Russia’s GDP is higher than any European country with the exception of Germany.

Within Brazil, Russia, India, and China, the middle class is expanding rapidly—growing at 21% a year to reach 1.8 billion people by 2014. The increased affluence is creating a greater demand for healthcare, in part because with changing lifestyles have come a growing incidence of chronic disease. India and China will make up nearly one-third of the world’s total patients with type 2 diabetes in 2030, with more than 150 million people afflicted with the disease by then.

Real GDP Per Person

The pharmaceutical industry has targeted these emerging markets as a primary source of sales growth in the coming years. With many products facing patent expirations and slowing sales growth in developed countries, big pharma sees emerging markets providing an opportunity to extend product life after loss of exclusivity in established markets. These markets have a high regard for brands, giving the originator a leg up over generic competitors.

Big Pharma is also investing in research and development around the world to take advantage of low-cost talent, local expertise, and proximity to new markets. For example, Merck in 2011 said it would commit $1.5 billion to expand its research and development activities in China. Every multinational pharmaceutical company now is establishing a presence in the major emerging markets countries.

And it’s not just traditional big pharma, but biotechs as well. Amgen has been steadily diversifying into emerging markets, entering Brazil in a big way with its $215 million buy of Bergamo, and establishing a foothold in the Middle East with the $700 million acquisition of privately held Turkish pharmaceutical firm Mustafa Nevzat.

Pharmaceutical Sales and Growth in Emerging Markets

New Focus

Once viewed solely as a source of inexpensive labor, these emerging markets are becoming sources of innovation. This is seen in the rapid increase in their contributions to scientific articles being published in peer-reviewed journals and patent applications being filed with the World Intellectual Property Organization. China is closing ranks with the U.S. as the top filer of patents applications and is expected to surpass it by 2015.

One striking example of this innovation shift is the rapid rise of BGI, formerly the Beijing Genomics Institute, to become the world’s leading sequencer of genomes. Backed by $1.5 billion in government funding, BGI has established partnerships and collaborations with leading academic and government research institutions throughout the world, as well as global biotechnology and pharmaceutical companies.

In February BGI teamed up with the Asia Cancer Research Group (ACRG) to conduct genomic research on lung cancer and liver cancer. ACRG was established in 2010 as an independent, not-for-profit company by Lilly, Merck, and Pfizer to accelerate research and, ultimately, improve treatment for patients affected with the most commonly diagnosed cancers in Asia by freely sharing the resulting data with the scientific community.

We are also seeing a global movement of scientists, who often come to the U.S. and Europe for education and business-management training. Unlike the recent past when they would remain and work in their adopted countries, they are returning to their native countries to take advantage of the growing opportunities available to them in their homelands.

Shifting to High-Value Industries

Perhaps the clearest sign of these countries as emerging sources of innovation is the concerted investment their governments are making to move their economies to high-value industries from a dependence on low-value commodities and manufacturing. They see biotechnology and other medical technologies as important drivers of economic growth and are investing heavily in education, infrastructure, and healthcare to develop homegrown industries to serve the needs of their people and fuel further growth of their economies.

Russia may be the leader in this trend, leveraging its financial strength to gain industry expertise. Government-backed investment funds have been making significant bets in innovative Western life science companies that are willing to set up drug development and manufacturing facilities in Russia. Rusnano, backed by $10 billion in government money, has entered into a $760 million partnership with U.S. venture capital firm Domain Associates to back up to 20 companies willing to develop their compounds in Russia.

China’s current economic plan calls for doubling biomedical R&D innovation funding from the previous plan to $300 billion. It seeks to make China the second-largest pharmaceutical market by 2020. South Korea has pledged increased funding for stem cell research, describing it as a “new growth engine.” Its drug agency approved the first therapeutic using allogeneic stem cells in January, developed by Seoul-based Medipost to regenerate knee cartilage using stem cells derived from umbilical cord blood.

Win-Win Opportunities

Life science companies facing a difficult funding environment in the U.S. are finding that one cost-effective way to develop their drugs is through partners in emerging markets. They can gain access to capital to fund development while retaining rights to their products throughout most of the world.

For example, Harbor Biosciences granted Sinopharm subsidiary China State Institute of Pharmaceutical Industry (CIPI) exclusive rights in China to three of its products in exchange for the Chinese government-owned pharmaceutical’s agreement to develop them. CIPI will finance all product development in China to two mid-stage compounds and one preclinical compound for major indications including diabetes, cancer, inflammation, and infectious disease.

Besides being eligible for milestone payments and royalties for sales in China, Harbor retains all rights outside China and can use the clinical data generated by CIPI to seek marketing approval elsewhere. Harbor advances its products through development without having to provide any financial support to do so.

By leveraging the needs in emerging markets, companies such as Harbor can obtain access to nondilutive financing, reduce development risk, and develop multiple compounds at once. For the emerging markets, these deals provide a way for these countries to build their economies, decrease their dependence on drugs produced outside their borders, and increase the high-value skills and technical skills of their workers as they address the health needs of their populations.

Such agreements take on varying forms. Rusnano, for example, often ties its investment in Western biotechs with agreements to develop their compounds and commercialize them first in Russia. Its investment in two Massachusetts-based biotechs, Bind Biosciences and Selecta Biosciences, include providing each company with $25 million to set up wholly owned subsidiaries in Russia to advance the clinical development of their pipeline candidates. They expect Rusnano’s commitment to help them in their partnering efforts, as well as help them access global sources of funding.

In other cases, deals take on the form of more traditional partnering arrangements. Maxwell Biotech Venture Fund, partially backed by the Russian government, licensed Maryland-based Sequella’s experimental antibiotic for the treatment of tuberculosis, which is an epidemic in Russia. Maxwell gains rights to the drug in Russia and neighboring Commonwealth of Independent States countries, where it will assume responsibility for further clinical development and regulatory approval.

Sequella gets a partner that can navigate the product through the local regulatory agencies, an equity investment, clinical supply purchase, and milestone payments worth up to $50 million, as well as royalties. Plus, Sequella retains all rights to the drug in the U.S. and the rest of the world.

In this way, companies can leverage an asset they may be ill-prepared to commercialize in an emerging market, and leverage the needs in those countries to accelerate development, cut costs, and reduce the risk of bringing those products to market in developed countries. At the same time, this global movement of technology and innovation can help boost the economies of the emerging countries and address unmet medical needs of their populations.

Challenges Ahead

This is not to say that doing business in emerging markets will be easy. Other than their economic potential, emerging markets have little in common. Their demographics, governments, regulatory policies, economic structures, healthcare systems, and cultures are quite disparate and must be taken into account when devising an emerging markets strategy.

Just as in developed countries, governments in emerging markets face increased pressure to rein in healthcare costs. In most of these countries, government regulations and policy are designed to benefit local companies, and demand that foreign companies wishing to do business in their markets establish local subsidiaries and partner with local firms. Their regulatory bureaucracies can be difficult to navigate, and businesses are often hampered by a lack of managerial expertise. Markets are often fragmented with many small players competing to get their products on official government lists of essential drugs.

The potential market is huge, however, and governments see the importance of investing in the life sciences to build innovation-based economies that can provide high-quality jobs. They see innovation as the way to transform their societies for the better, especially amidst the austere economic conditions and global challenges facing the world today. The challenge for innovative companies is to understand and be able to take advantage of global opportunities when and wherever they may arise. Those that succeed are posed to reap huge rewards.

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