EirGenix Inc (台康生技) has high hopes for its sales of recombinant proteins. The reason for this is that the proteins’ share of annual growth is expected to increase more than that of all other biopharmaceutical products in coming years, according to company president and chief executive officer Liu Lee-cheng (劉理成) in an interview on Friday.
“As a contract developer and manufacturer, EirGenix will generate revenue by offering services to other drug companies that will enable them to make recombinant proteins and to develop biosimilar drugs,” Liu said in the company’s headquarters in Sijhih (汐止), New Taipei City (新北市).
EirGenix is a brand new venture between government agencies and private investors that was launched on Tuesday. It has the nation’s only plant for making recombinant proteins that are less toxic, while having a higher potency than other drugs.
The factory has two mammalian cell culture bioreactors, one with a capacity of 300 liters and the other of 500 liters, according to the company.
The recombinant protein market is huge. Global sales account for one-third of total sales of all biopharmaceutical products. In 2010, global biopharmaceutical sales were US$134 billion and the numbers are expected to grow 4.6 percent every year on average to US$176 billion in 2016.
Yet of this, sales of recombinant proteins will be growing at the compound annual growth rate of 8.2
percent over the same period, Liu said.
Furthermore, between this year and 2015, patents of 32 recombinant proteins have expired, opening up a market of around US$45 billion for biosimilars, he said.
Based on data provided by the government-funded Development Center for Biotechnology (DCB), there are 16 recombinant protein drugs and biosimilars under phase one and two clinical trials in Taiwan. Six drugs are under phase three study.
“However, it will not be enough for us to just offer services to Taiwanese companies — we are aiming to find customers in Japan and Germany as well,” Liu said.
To meet the potential demand from an expanding customer base, the company plans to expand its capacity by replacing its bioreactor of 300 liters with a single use bio-
reactor of 1,000 liters in the second quarter next year, and by building two production lines of 3,000 liters next year, with one of the lines to be operational in 2016, Liu said.
“With larger capacity, we can take orders from customers who require 1,000 liters or more,” Liu said, adding that some customers prefer larger orders with lower average costs.
EirGenix’s factory was built by the DCB in 2005 to promote the development of recombinant proteins. Active pharmaceutical ingredient maker Formosa Laboratories Inc (台耀化學) won the bid to operate the factory in January and set up the business with an investment of NT$90 million (US$3.03 million) from the DCB and NT$60 million from the National Development Fund. EirGenix’s capital is currently valued at NT$540 million.
The company’s factories will also be used for the clinical trials of biosimilars transferred from the DCB: EG-001, which is used to treat breast cancer, and EG-002, which is used to treat colorectal cancer, as well as breast cancer, Liu said.
The company will file an investigational new drug application for EG-001 in the US and Europe next year, while EG-002 will have to wait until 2015, Liu said, adding that the company will find local partners in every country to register and market these drugs.
He estimated the market values for both drugs are about US$6 billion each. To fund its capital spending, and research and development, the company plans to raise another NT$450 million to NT$600 million in the second half of next year. The company is looking for foreign investors to participate in the fund-raising, Liu said.
However, EirGenix is not without possible competitors. Mycenax Biotech Inc (永昕生醫) is building a factory with a capacity of 2,000 liters, while Amaran Biotechnology Inc (潤雅生技) is constructing a factory for the manufacture of Botox, which is widely used in cosmetic surgery. PharmaEssentia Corp (藥華醫藥) has a factory to make 1 million units of drugs a year.