Dong-A Pharmaceutical Antibiotic Targeting Superbacteria Enters Phase I Clinical Trial

Dong-A Pharmaceutical (President Won-Bae Kim) received USFDA approval to enter phase I clinical trial for its DA-7218 antibiotic targeting superbacteria. Trius Therapeutics, an American antibiotics developer, has licensed DA-7218 (known in America as TR-701) and made a down payment to Dong-A. Royalty payments are expected to begin in the near future. Trius submitted its IND (Investigational New Drug) application on November 28, 2007, and received approval early in 2008 to launch the phase I clinical trial. 88 healthy male and female subjects will receive repeated administrations of TR-701 beginning from January 7, 2008. The trial will conclude around June, 2008. During animal testing, DA-7218 (TR-701) showed excellent antibacterial effects and greater safety than Zyvox, the only other oxazolidinone-type antibiotic to be tested on animal models. The Dong-A drug also improves convenience, being administered once daily, as compared to twice daily for Zyvox. Animal testing confirmed the drug fastness, safety and pharmacokinetics of DA-7218 (TR-701), in addition to the efficacy of the once per day administration regimen. DA-7218, along with other oxazolidinones, functions by attacking the protein-synthesis machinery of bacteria. Testing has shown that the drug has excellent effectiveness against VRE (Vancomycin-Resistant Enterococcus), MRSA (Methicillin-Resistant Staphylococcus Aureus) and PRSP (Penicillin-Resistant Streptococcus Pneumoniae). Its antibacterial effectiveness has been found to be four times greater than currently available products, and it is applicable to a wider spectrum of bacteria with reduced side effects. Additionally, the once-daily administration regimen will make DA-7218 more preferable to patients, who face twice-daily injections with currently available products. Trius Therapeutics plans to commence phase II clinical trial with actual patients by the end of the year, following successful completion of the hase I clinical trial. Explaining the advantages of the strategic alliance with Trius, a Dong-A official said, “Licensing approved drugs can be prohibitively expensive, as the patent holder must recover all R&D and clinical trial costs. By licensing DA-7218 in the preclinical stage, Trius is able to limit expenses, and the quality of Dong-A’s R&D work is recognized.” # # # About Dong-A Pharmaceutical Dong-A is Korea’s leading pharmaceutical company. Based on its corporate philosophy that the greatest value is life, Dong-A strives to be a responsible corporate citizen that contributes to the health and welfare of humankind. Over the past 42 years, Dong-A has maintained a reputation as a trustworthy producer of quality pharmaceutical products, and has risen to become the number one drug company in Korea. It is expanding its overseas presence on the strength of its new drug and biopharmaceutical products. Dong-A Socio Group includes Dong-A Otsuka, a beverage company, and Yongma Logis, a 3PL specialized company, and other subsidiaries.

The release as fetched from its publisher. donga-st.com ↗