Dong-A ST’s new global drug most likely to be approved and marketed soon
Dong-A ST submitted NDA to the FDA for Tedizolid Phosphate (DA-7218), antibiotic treatment for super bacteria

-Application submitted in October 2013, with its approval expected in the second half of 2014
-Application for sales in Europe to be submitted in the first half of 2014
-FDA approval for a new drug will be the first for Dong-A ST and the second for Korea

The likelihood that Tedizolid (product code DA-7218), a super antibiotic developed by Dong-A ST to treat acute skin infections, will be approved and made available on the world market has risen sharply.

On October 23, 2013, Dong-A ST (President Park Chan-il) announced that it had submitted to the U.S.’s FDA its New Drug Application (NDA) for Tedizolid, a super-bacteria antibiotic, which it outlicensed to Trius Therapeutics of the United States in January 2007.

The application was made by Cubist Pharmaceuticals, which took over Trius in September 2013. It is based on two phase III trials for 1,333 subjects around the world including the USA and Europe in the indication of ABSSI (acute bacterial skin and skin-structure infections) caused by gram-positive bacteria including drug resistant bacteria like MRSA (methicillin-resistant Staphylococcus aureus). As previously disclosed, Tedizolid satisfied the efficacy evaluation factors under the guidelines of both the FDA (the Food and Drug Administration) and the EMA (European Medicine Agency).

Therefore, Tedizolid is highly likely to become only the second medicine developed by a Korean pharmaceutical company ever to be approved by the FDA, following in the wake of Factive, an antibiotic developed by LG Life Science back in 2003. Once approved, the drug will become Dong-A ST’s first new medicine approved and sold in the United States. Meanwhile, Dong-A has already begun to embark upon R&D on Gram-negative bacteria, which is known to be spreading rapidly in many countries including the USA and Japan. With the aim of fighting all types of super bacteria around the world, Dong-A ST is striving to develop the second DA-7218 as early as possible.

Trius Therapeutics sublicensed the rights to develop and sell Tedizolid in Asia and other emerging markets to Bayer in 2011. Therefore, Bayer, as the sub-licensee, will be in charge of sales in China, Japan and other Asian and emerging markets once the relevant clinical trials have been completed and the due approvals secured. Elsewhere, Cubist will take charge of North America and Europe, while the originator of the medicine, Dong-A ST, will be responsible for the Korean market. Therefore, Tedizolid will become a globally-available drug sooner rather than later.

“Worldwide, MRSA is emerging as a serious threat in both clinical and economic terms. We are extremely happy about the prospect of offering Tedizolid to a great number of patients suffering from acute skin infections as well as to healthcare providers around the world because of its outstanding advantages, including its excellent tolerance, convenience as a medication (once daily), and shortened treatment periods,” said President Park Chan-il. “Therefore, Tedizolid will not only increase patients’ comfort through once-a-day dosing within a shorter period of time, but it will also make considerable contributions to their economic welfare.”

Tedizolid is an oxazolidinone developed for both intravenous and oral administration for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In January of 2013, it was designated by the FDA as a QIDP (Qualified Infectious Disease Product) eligible for faster approval and priority reviews with regard to ABSSSI and hospital-acquired and ventilator-associated bacterial pneumonia. As a result, the NDA review period has been shortened considerably and the drug is most likely to be approved by the FDA in the second half of 2014.

Also, the phase 3 clinical trials for Tedizolid are designed to meet the registration requirements of both the United States and Europe as outlined in the guidelines of the FDA in the US and the EMA (European Medicines Agency) in Europe in relation to the evaluation of the efficacy of the antibiotic. Cubist plans to submit a Marketing Authorization Application (MAA) to both Europe (EMA) and Canada during the first half of 2014 while embarking upon phase III trials for patients of hospital-acquired and ventilator-associated bacterial pneumonia at the end of 2013.