Here at Mycenax, our vision is from bench to better life which is to turn the good discovery in the laboratories to brilliant commercial products via our chemistry, manufacturing and controls (CMC) foundation. We have all the key ingredients to develop and manufacture biotechnological products, such as recombinant protein, monoclonal antibody and DNA. Thus, utilizing this ability, we develop our in-house pipelines which are biosimilars which are lower risk and quick benefit to local needs. Then we’ll enter into new drug development in the future. In the mean time we provide these capabilities for CDMO service (contract development and manufacturing organization).
Can you share with us the history of Mycenax?
Mycenax was started in 2001, and we spent the first three years in fund-raising. At that time, our aim was to build a biomanufacturing facility with single use technology as the foundation. By way of this facility and capability, good projects in the lab can be realized into clinical phase and finally into commercialization. It was a pure CDMO service company. The four founders worked hard in those three years to raise the money, and convince Taiwanese investors that the disposable model was workable. At the mid of 2003, we got minimum money including Mr. Rongjin Lin, TTY’s chairman’s input. Mr. Lin understood the pharmaceutical trend and believed biological products will play a substantial role in the pharmaceutical market. Thus, after our facility was completed, Mr. Lin took us to more investors including National Development Fund and other important investors. We started our first product, TunNEX, to develop and demonstrate our product development capabilities.
Most big pharma companies are vertically integrated, but the model in Asia is to use holding companies with separate entities under them. Why is that the best model here?
The first reason is that if a company has lots directions but limited resources. It may raise internal competition for resources, which slows down development. There are lots examples in the giant company. The second reason is that spinning off companies can get outside support easier than a giant company.
Some companies in Taiwan that are focused on drug development also offer services in order to pay the bills, given the investor profile and appetite in the country. Does Mycenax share this philosophy?
Having its own pipelines and providing services are not special in the biotech or pharmaceutical industry. It is not a Taiwan special style, but it is a really common business route in the world. Biopharmaceutical industry is not like the IT industry. Biotechnology derived products have their own nature. The development time is long and complicated. Different process makes different product. Entrance barrier is high. Thus it has a longer life cycle. It is easy to trace if the product is a copy version. Intellectual properties are highly respected in Mycenax. Our partners can be sure that we there is no conflict of interest down the road. IP is something that has to be addressed in Asia, although Taiwan is much better at respecting IP than other countries in the region. There is no conflict interest to be a product developer and contract service provider in Mycenax.
Today, investors are a little more accepting of the pure drug development business model, but in the beginning of the Taiwanese biotech sector, people were used to investments with faster turnaround times, as a result of the development of the IT sector. This is starting to change as time goes on, and people get more used to the idiosyncrasies of the biotech sector.
CDMO service enables us to look for potential partners. So therefore, we carry out CMO work, and hope to make long-term relationships with our clients, so that they will continue to come to us with development work. Later along the road, we hope that from some of these partners, we can launch shared investment projects, and plan a long pipeline together with them.
Mycenax has its first product in Phase III testing right now. Can you tell us a little bit about this product and the rest of your pipeline?
TuNEX, our first product, is etanercept- biosimilar which is in the top three selling biological products in the latest 10 years. The innovator product is Enbrel, a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Our current development status is in phase III. TSH pharma is our partner for clinical studies and marketing/ sales in Taiwan and China. We believe biosimilar is regional expansion. Thus, we will look for partners in different regions with shared dossier.
We will focus on autoimmune products for our product pipeline to be developed on our own, and collaborate on products in different treatment areas. Our business plan is to make our own biosimilars as keystone, and use this as a way to enter the new drug market.This way, we are also looking at new molecules, but with a limited, exploratory budget. We hope to develop our own molecule by 2015.
When your pipeline becomes strong enough, will you stop providing services?
CDMO service provides us not only revenue but also new opportunities. We focus on our pipeline development but in the mean time to maintain a certain amount of income from contract services. Our aim is to continue to cover our costs with our services, as our business expands over the coming years.
If we find ourselves in a situation where we are doing more CDMOs, we can spin off to another company focused solely on CDMO, but right now it is too early to consider this.
We recently announced the building of a 2000-liter disposable facility, the largest in Taiwan, which will be completed in Q1 2014. Benefited from such disposable and modular design, we can license out pipeline and make local production a more feasible option to partners around the world. So this is how we can penetrate this market, and develop links and partnerships with companies all over the world.
What is the outlook for Mycenax in 2013 and beyond?
We have split the long-term plan for the company into three stages. The first was preparation, which ran from 2004 to 2012. We established the value chain of biologic development through TuNEX and GranNEX projects. We are now in the expansion stage, which we plan to push until 2017. From there, we will have more biosimilar pipelines and get into new drug development. Finally, we can tackle the world market, and hopefully play an important role in the world in the field of autoimmune diseases.
Everything is now starting to move for us, as we have successfully completed our preparation stage. We are currently applying for an IPO, and are in the pre-GreTai stage, which is necessary for companies applying for entry to the Taiwanese stock market. TuNEX will be the first biosimilar to come from Taiwan, a big accomplishment.
What do you want to do with the funds raised by the IPO?
We will build a large new facility for several 2000-liter suites, expansion and more pipelines development.
Is this what you envisioned for Mycenax in 2001?
In 2001, the original plan for the company was to provide CDMO services with sites in the US and Taiwan to facilitate global development, but this did not work out. However, now we have our own pipelines and provide CDMO services globally with fully support from the investors. It is far more than what we expected in 2001 and we will keep moving toward to our vision.