Commercial production of Hecolin, the only vaccine against Hepatitis E started in a Chinese factory a few weeks back. Hepatitis E, a water-borne disease infects 2 crore people annually, majorly infesting the developing nations in the south-east Asia.
Of these, nearly 30 lakhs are acute cases. Nearly 4% of the cases lead to acute liver failure, resulting in death. Sanitation measures were the only counter-measure before now.
Xiamen University researchers genetically modified an E. coli strain to produce a protein which on injection into humans stimulated the body’s immune system against the causative Hepatitis E virus. Trials could be performed only after Yangshentang, a company involved in food and health care, funded USD 1.8 million to set up a joint venture with the university in 2000. Approval for the drug was granted by the China State Food & Drug Administration (CSFDA) in December 2011.
Hope for the Over-looked
Bringing a drug from conception to commercialisation takes around 10 to 12 years and nearly USD 0.8-1-.8 billions. The researchers at the pharmaceutical companies start with over a thousand different molecules and narrow down it to a single over multiple phase testings. The business involves a lot of risk and hence these companies haven’t been much enthusiastic to develop against certain diseases.
Diseases which are observed in less than 7.5 people per 10,000 are considered rare. These, owing to the relatively small market they constitute, don’t attract the pharma industry. Diseases which exclusively or to a major extent inflict the under-developed nations, too, aren’t big enough baits for the industry.
The former kind has recently been addressed with personalized medicine or drugs specific to the genetic subtype of the patients which reduces the developmental costs because even smaller samples give statistically significant results. The latter kinds require a public-private development model to ensure that treatments surface even if they aren’t profitable.
Public-private development model
Biotechnology as a field grew due to collaborations between the industry and the academia. Industries poured in cash to university laboratories and the laboratories handed back novel molecules, technologies. The biotech revolution made entrepreneurs out of professors and ensured that the field progressed at a rate that would put even the IT to shame.
Sometimes, certain problems lure the researcher but the lack of economic prospects don’t lure the entrepreneur. Glaxo-Smith Kline had, in collaboration with the US army, already developed a drug against Hepatitis E which had promising phase II trial results, but didn’t bring it to the market due lack of foreseeable gains.
The government laboratories must join hands with biotech firms to come up with solutions against previously-uncared-for diseases. It involves risk and determination at both the government and the entrepreneurial levels and much excitement is bound to follow at the students’ level.
Asia’s rise in the life sciences
The awarding of this year’s Nobel Prize for medicine to Shinya Yamanaka for his work on induced pluripotent stem cells has helped Japan shed its image as a nation good for technology alone. It has signalled their deterministic advance into basic and applied research. Beijing Genomics Institute in China has the world’s largest DNA sequencing facility.
Stem cell research is not controversial at all in China and Israel. Controversies on stem cells and alike were the reason behind many American scientists migrating to Britain which have put the US dominance in a shaky position. China is advancing to become the world leader in regenerative medicine through progress in tissue engineering and gene therapy.
By 2006, Israeli scientists led on a per capita basis in the number of articles published in scientific journals related to stem cell research. Japan, Korea, Israel and China share a knack for technology and it won’t be surprising if they beat Europe and the US in the healthcare sector in a decade’s time.