- Phase 2 clinical trial commenced in the U.S. just in 19 months after licensing, high likelihood of
commercialization
- Phase 1 clinical trial reaffirmed the drug’s excellent efficacy and competitive marketability
Seoul, September 25, 2008 - Super bacteria-targeting antibiotic DA-7218 (re-coded as TR-701 by Trius after in-
licensing, hereafter “DA-7218”), that in February 2007, Dong-A Pharmaceutical (CEO Kim, Won-Bae) licensed to
Trius Therapeutics (a biopharmaceutical company developing antibacterial drugs for the treatment of serious
infections, located in San Diego, USA), has entered a phase 2 clinical trial as of September 22, 2008. This will
entitle Dong-A to receive the second milestone payment from Trius in addition to the initial up-front
payment.
In animal studies DA-7218, oxazolidinone class antibiotic, showed more potent antibacterial activities and a
broader safety margin than Zyvox of Pfizer, the only marketed drug of the oxazolidinone class, and it also
presented a potential for once-daily dosing, which can be differentiated from b.i.d. dosing of Zyvox.
This Phase 1 clinical trial results indicate that DA-7218 will be a once-daily drug with the potential to offer
patients several important advantages over Zyvox as well as other marketed drugs. Results of the Phase 1
trials will be presented at the joint annual meetings of the Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) in Washington, D.C in October
2008.
“The growing epidemic of MRSA in the community leaves few viable treatment options for patients requiring an
oral drug,” said Jeffrey Stein, Ph.D., Chief Executive Officer of Trius. “We believe that the once-daily dosing
and short course of TR-701 therapy of five to seven days will offer a clinical advantage for patients and a
potential pharmaco-economic advantage for insurers and others concerned about the increasing cost of
healthcare.”
A source at Dong-A Pharmaceutical said, “Many new drugs that Korean pharmaceutical companies licensed
out to foreign partners are likely to be abandoned in the middle of development or are under slow development
category by partner companies. However, we are encouraged with the rapid development of DA-7218 by our
partner company specializing in the development of antibiotics. Successful completion of the phase I study and
smooth jump onto this phase 2 study imply the possibility of commercialization of DA-7218, and it reaffirms Dong-
A’s global competitiveness in R&D.
The oxazolidinone class antibiotic DA-7218, inhibiting protein synthesis of bacteria, shows great efficacy
against super bacteria that are resistant to conventional antibiotics. It is highly effective against super bacteria
such as VRE (Vancomycin-resistant enterococcus), MRSA (Methicillin-resistant staphylococcus aureus), ad
PRSP (Penicillin-resistant streptococcus pneumonia), etc. DA-7218’s 4-fold higher potency, broader
antibacterial spectrum and higher safety margin over Zyvox can be highlighted. DA-7218 is representing the
potential of once daily dosing and the possibility of developing iv bolus preparation, which will improve patient
compliance in comparison over the existing drug that should be administered or injected two or three times per
day with higher dose.
Dong-A Pharmaceutical, one of the Korea’s leading research-based pharmaceutical and
healthcare
companies, is committed to working for a better tomorrow by following its core value of integrity, excellence and
respect for humanity. Dong-A Pharmaceutical has kept its No. 1 position in the Korean pharmaceutical market
since 1967 with its Zydena(erectile dysfunction treat