EirGenix And Formosa Laboratories Collaborate To Establish A Platform For ADC CMC Integration Services
7/18/2014 8:39:13 AM
EirGenix Inc. has announced that it has formed a strategic alliance with Formosa Laboratories Inc. to provide ADC integration via contract development and manufacturing services and to initiate their EG12014 monoclonal antibody (mAB) and antibody drug conjugates (ADC) development project. This move will secure both parties’ competitive advantage as there are only a handful of firms in the world that are capable of providing clients with elegantly integrated development and manufacturing solutions for all ADC components, i.e. mABs, linkers and payloads (cytotoxic compounds), under a single window.
Taiwan's Ministry of Economic Affairs (MOEA) has signed a contract to provide a grant worth $75 million NTD, equating to 42% of their total estimated development budget of $175 million NTD, to support this two-year project starting from April 2014. This high budget allocation gives evidence to the strong confidence and ardent support from the MOEA.
This strategic alliance relies on EirGenix’s expertise on the development and manufacturing of protein drugs, protein characterization and analysis, and Formosa Laboratories’ experience with manufacturing synthetic drugs and developing high potency payloads. These complementary specialties cut the need for clients to contract multiple CDMOs and the vertical hierarchy will allow clients to reap benefits such as high levels of product customization, stringent quality control, shorter production spans and economies of scale.
While there are only two ADC drugs on the market now, the demand has experienced a huge surge in the recent years. In particular, Roche’s breast cancer drug, Kadcyla, was released last year is expected to turnover $2 to $5 billion in 2014 because it possesses a higher cure rate when compared to existing gold standard of treatments. Many firms in the pharmaceutical and biopharmaceutical industry have turned their heads in the direction of Roche’s success and now there are over 30 ADC drugs that have entered clinical trials already.
Besides the few firms in the world that provide integrated services for all components of ADC drugs, the EirGenix and Formosa Laboratories alliance will become the first and only entity in Taiwan that will be capable of doing so. With undivided focus and cooperation, the two firms aim to launch themselves as major competitors into the international markets.
In order to speed up the project and build up a track record, EirGenix is also cooperating with an Austrian firm and ITRI using their biosimilar EG12014 as a carrier to adopt viable linkers and toxins. Concurrently, the firm will develop mass production and analytical methods while performing in-vitro tests. Ultimately, it is planned that EG12014 will reach clinical trials in 2015.
EirGenix aims to become the vanguard of Taiwan’s ADC drug development and hope that not only will it provide quality service and economic solutions to its clients, it will further stimulate the global demand for the drugs. Additionally it wishes that the project’s success will advance the industry standards and ultimately drive new goals and directions for the fellow pharmaceutical and biopharmaceutical firms and encourage their mutual growth through cooperation and trust.
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