Market Application for LG Chemical

제목 없음 LG Chemical Ltd. announced today that its fluoroquinolone antibiotic, discovered by its Biotech Research Institute, completed phase Ⅲ clinical trials successfully and submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration(FDA), for the treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute sinusitis as well as for urinary tract infections. LG Chemical is the first Korean company to succeed in discovering a new material that completed the clinical tests worldwide including U.S. and Europe and has applied to FDA. In 1997, LG Chemical had signed a worldwide development and commercialization agreement with the world‘s leading pharmaceutical company, SmithKline Beecham. Under the terms of agreement, SmithKline Beecham has the right to market the material with its own product name, ‘Factive™’. LG Chemical retains the co-promotion marketing right in some Asian countries and the right to supply the drug substance to SmithKline Beecham. LG Chemical‘s licensing partner, SmithKline Beecham conducted the Phase III clinical trials involving more than 8,000 patients in about forty nations to evaluate the clinical efficacy. This potent,novel, broad-spectrum agent proved to be efficacious with just one dosage per day compared to two dosages required by comparator quinolone antibiotics. It proved to be the potential next generation antibiotic by showing excellent potency even against strains resistant to other antibiotics. This is especially significant considering that at present, the increasing resistant bacterial pathogens to antibiotics is becoming a worldwide clinical problem. LG Chemical expects the new quinolone to be commercialized in the later half of year 2000. Factive is expected to be a market leader blockbuster drug due to the superior quality and the strategic marketing plan by SmithKline Beecham. In October, 1999, the construction of a new pharmaceutical plant, compliant with FDA guidelines, was completed in Iksan, South Korea to produce the fluoroquinolone antibiotic. When the demand increases from SmithKline Beecham, LG plans to construct a second plant in 2001. Quote from LG Chemical "This is truly the most splendid achievement for Korean pharmaceutical industry. Completing the clinical trials successfully in the U.S. and Europe, and submitting application to FDA proves the superior efficacy and safety of this new fluoroquinolone antibiotic," said, Dr. Soon Jae Park, pharmaceutical division at LG Chemical.

The release as fetched from its publisher. lgchem.com ↗