LGLS, Korean Biopharmaceutical Pioneer

Company has deep biologics and biopharmaceuticals pipelines; aims at evolving into a world-class life science company

In the early and mid 1980s, large Korean companies, including subsidiaries of conglomerates, rushed to make huge investments to tap the burgeoning Korean biomedicine manufacturing industry with its huge future growth potential, but a majority of them had to quit the business due to hundreds of billions of won in losses due to a failure to commercialize, especially in the wake of the 1997 Asian financial crisis.
LG Life Sciences (LGLS) was also faced with a crisis of dissolution, but managed to survive thanks to extensive support from the late LG Group founder Koo Ja-kyung. LGLS was initiated as a genetic engineering department of LG Chem in 1981 and was spun off from the chemical company in 2002.
The company has since come from strength to strength to become the nation’s biopharmaceuticals industry leader. The experience and expertise LGLS have accumulated in the pharmaceutical field for almost 20 years has put it on the right track toward the goal of becoming a global biopharmaceuticals company.
LGLS has a track record of having successfully developed and commercialized biopharmaceuticals on its own: in 2002, LGLS became the sole Korean company to have its new chemical drug, FACTIVE™, approved by the US. Food and Drug Administration (FDA).
In the R&D sector, LGLS has made visible advances: SR-hGH is currently under U.S. FDA review for approval after completing the third phase of clinical trials; LGLS’s liver disease treatment has entered the latter stage of the second phase of global clinical trials; their diabetes treatment is now in the third phase of clinical trials; and the BEPO has been designated as a smart project by the Korean government.
Specifically, LGLS has become a global leader in the growth hormone segment. In 2006, LGLS had its growth hormone treatment, Valtropin™, approved by the European Medicines Agency (EMEA), the second drug of its kind in the world. The growth hormone drug was approved by the U.S. FDA in 2007. The U.S. FDA approved LGLS’s pharmaceutical plant in Iksan as a site for producing small molecules and biopharmaceuticals. LGLS has domestically launched Europin Plus™, the world’s only sustained release pediatric growth hormone following the successful development of the exclusive technology. Europin Plus™ is a sustained release product of Europin™, for managing short stature due to a lack of human growth hormone. It is the world’s only human growth hormone that requires weekly rather than daily injections. LGLS has commenced phase III clinical trials for this drug to enter the markets of advanced countries including the United States.
Europin™ holds a 65 percent share in the Korean recombinant human growth hormone segment (rhGH).
LGLS strives to lead the future in growth hormone therapy. LB03002, an adult and pediatric growth hormone treatment, is the first and only once-a-week rhGH product, also called somatropin, which is in phase III development in the United States and the EU. LGLS expects LB03002 to lead the rhGH segment with the potential to provide better compliance, persistence and better overall outcomes.
In particular, Biohydrix (Biocompatible Hyaluronan-based Sustained Release Drug Matrix) is LGLS’s platform technology that can transform a daily subcutaneous injection to a weekly injection. Based on a unique hyaluronan microparticle matrix, API (Active Pharmaceutical Ingredients) slowly diffuses out of the matrix. The hyaluronan matrix is biocompatible and is completely degraded in the human body after releasing the API. Biohydrix is safe and non-inflammatory. It maintains the stability of the API, preventing it from being denatured or aggregated as in other SR technologies.
These results not only demonstrate the fact that LGLS has the capability to create results in the R&D sector, but also has in place a stable profit structure that allows the company to have the highest percentage of R&D expenses in Koreas while generating an operating income of over 10 percent, as well as proving that LGLS is a company equipped with an R&D pipeline that has the potential for sustainable growth and development as a global corporation.
LGLS is also striving to expand its business portfolios to biosimilars abroad. The company is now developing biosimilar monoclonal antibodies. It plans to enter the United States and EU markets with seven to 10 biosimilar monoclonal antibodies while seeking joint ventures of all types.
LGLS devotes itself to making 2010 a year of growing together with its customers. To set it on the right course for the year, LGLS has targeted six strategies that it will focus its attention on: Incorporate the LG Way into every life; use R&D to create value; produce the best quality products; establish a sound financial structure; grow its overseas business; and strengthen its position in the domestic market. LGLS is making steady progress toward its vision of becoming one of the world’s top life science companies. Its goal is to serve humanity with world-class products that improve people’s quality of life. nw

LGLS has become the sole Korean company to have its new chemical drug, FACTIVE™, approved by the U.S. FDA.