Dong-A’s super bacteria-targeting antibiotic successfully completed phase 2 study in the US



- Phase 2 clinical trial completed in the U.S. within just 28 months after licensing, high likelihood of
commercialization as a new drug.



- High clinical cure rates in all doses evaluated, no study discontinuations due to adverse events in phase 2
study.



Seoul, June 9, 2009 - Dong-A Pharmaceutical (Won-Bae Kim, CEO) announced that phase 2 clinical trial of
super bacteria-targeting antibiotic DA-7218 (re-coded as TR-701 by Trius after in-licensing, hereafter “DA-
7218”), which in February 2007 Dong-A had licensed to Trius Therapeutics, Inc. (a biopharmaceutical company
developing antibacterial drugs for the treatment of serious infections, located in San Diego, USA), has been
successfully completed. The phase 2 clinical trial evaluated the safety and efficacy of oral DA-7218 for the
treatment of severe complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria,
especially drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). The study
achieved its primary goals of establishing safety and efficacy in all doses evaluated.



In the randomized, double-blind, dose-ranging study conducted at eight centers in the U.S., DA-7218 was
administered orally at doses of 200, 300 or 400 mg once-daily for five to seven days of treatment. Of the 188
patients who received the drug, 164 (87%) were clinically evaluable at the test-of-cure visit. The overall cure
rates of clinically evaluable patients for severe abscesses, cellulitis and wound infections were 96%, 97% and
90%, respectively. Clinical cure rates by dose in the clinically evaluable population were 98%, 94% and 94% for
the 200, 300 and 400 mg doses, respectively. In the group of microbiologically evaluable patients (133, 71%),
clinical cure was achieved in 100%, 93% and 96% of patients receiving 200, 300 or 400 mg doses, respectively.
Highlighting the growing problem of drug resistance in the community, MRSA was the primary pathogen in 72%
of the microbiologically evaluable patients.



While oxazolidonone class antibiotics has shown some adverse events of myelosuppression (decrease in the
number of platelets, white blood cells and reticulocytes) as a class effect, DA-7218 was well tolerated in
patients enrolled in this Phase 2 trial and the laboratory results showed no significant shift from baseline in
hematology or chemistry parameters, including platelets or liver enzymes, after the administration of DA-7218.
Importantly, there were no study discontinuations due to adverse events.



“I was impressed by the rapid clinical effect of oral DA-7218 in curing severe skin infections caused by MRSA
and other gram-positive pathogens,” said Dr. Joseph Surber, Chief Medical Officer, Southeast Regional
Research Group, Columbus, GA, a clinical investigator of the Phase 2 study. “The nature of such infections
usually warrants use of an IV antibiotic, but the trial results indicate that oral DA-7218 successfully treated
these severe infections quickly and effectively.”



In the prior phase 1 clinical trial, DA-7218 showed the advantages over Zyvox by confirming the possibility of
once-daily dosing, which was presented at Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) held in Washington, D.C. in October of 2008.



“The efficacy and safety of DA-7218 in this trial demonstrate its potential for the rapid treatment of severe
infections caused by Staph aureus, including MRSA, in both the community and the hospital. Collectively,
these data enable us to select the 200 mg dose, the lowest dose among all doses evaluated, for our phase 3
pivotal trials in complicated skin and soft tissue infections.” said Jeffrey