Development History of Korea's 1st New Drug, FACTIVE

A challenge for U.S. FDA's new drug approval

In April, 2003, FACTIVE, the company's 4th generation quinolone antibiotic, became the first new drug developed in Korea to be approved by the US FDA. This U.S. FDA approval of FACTIVE opens the doors for our new drug to be commercialized in the world market including the U.S. market. LG Life Sciences' 12 years of FACTIVE research since 1991 has finally paid off to acquire the U.S. FDA? new drug approval.
This was the most important milestone event in the 106 year-history of Korean pharmaceutical industry since the foundation of the nation's first modern pharmaceutical company in 1987. The developmental process of FACTIVE falls into a long-run history of Korean pharmaceutical industry's new drug development after countless challenges and obstacles. Since the researchers of LG Life Sciences did never give up and devoted all their efforts and time into their research days and nights, they could finally succeed in solving the problems of the research and synthesizing an oxime-structured, epoch-making new drug material.
LG Life Sciences faced difficulties; FDA's approval of FACTIVE through strategic partnership with GSK was put on hold in 1999, and GSK pulled out of the joint development project of FACTIVE, leaving LG Life Sciences work alone to proceed in securing the FDA's new drug approval. However, this successful development of new drug after facing many challenges has set an example for the future paths of Korean pharmaceutical and life-science industry.

ONGOING CHALLENGE OF FACTIVE -
FACTIVE has faced a challenge in the global antibiotic market, due to absence of next generation of quinolones, emergence of generics and sales competition. However, LG Life Sciences' strategic partners, pharmaceutical companies specializing in respiratory systems, has the sales right and has set on targeting the global quinolone market. With FACTIVE on sale in many regions all over the world currently, the change of sales of FACTIVE has been detected. In Turkey, the sales of FACTIVE ranked the 1st place in the quinolone antibiotic class beating all other quinolone products from multi-national companies. In Tunisia, Saudi Arabia, and Mexico, the sales are steeply on the rise. LG Life Sciences is carrying forward its plan in commercializing FACTIVE in all over the world, and different countries together with local market leading companies including Abdi Ibrahim (Turkey), Pfizer (Mexico), Ache (Brazil), Hikma (Middle East & North Africa), and Livzon (China), etc. Until lately, FACTIVE has been approved in 30 countries including the U.S., Mexico, Turkey, Russia, China, and Brazil. The safety and efficacy of FACTIVE for multi-drug resistant S. pneumonia have been approved through its more than 7 million prescriptions all over the world. Therefore, based on this superior quality, FACTIVE is establishing its solid foothold in world markets. LG Life Sciences achieved the sales revenue of US$15 Million for FACTIVE last year, and expects to increase sales revenue in this year as well. Moreover, in near future, it is greatly expected that FACTIVE will help cure patients suffering from resistant bacteria in more and more countries. nw

The first U.S. FDA-approved new drug in Korea ― FACTIVE, is a quinolone antibiotic indicated for the treatment of acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute bacterial sinusitis and otitis media in more than 30 countries. It is also the first-ever FDA-approved drug for its superiority against MDRSP (MDRSP; Multi-drug resistant S. pneumoniae).

Photo on Courtesy of LG Life Sciences