Dong-A ST steps up commercializing two- or three-drug therapy by combining DPP-4 inhibitor diabetes treatment Suganon and SLGT-2 inhibitors.
According to KIPRIS, a patent-related information search service, on Tuesday, Dong-A ST applied for patents for two trademarks – Sugadapa and Sugadapamet – on June 2. Both trademarks’ designated products (the scope of products that have the effect of registered trademarks) are metabolic drugs and drugs for preventing diabetes.
Sugadapa is the name of the two-drug combo treatment for diabetes, for which Dong-A ST applied for item permission from the Ministry of Food and Drug Safety in July.
Applying for Sugapada’s approval, the company said it was the compound of evogliptin 5mg, the main ingredient of its new diabetes treatment Suganon, and dapagliflozin 10 mg in the SGLT-2 inhibitor family. The company is waiting for the review result by the Ministry of Food and Drug Safety.
Dong-A ST expects its launch of the combo therapy of DPP-4 inhibitors and SGLT-2 inhibitors to improve blood sugar control in people with diabetes and improve convenience and medication compliance.
The company’s plan to commercialize the combo therapy of DPP-4 inhibitors and SGLT-2 inhibitors was also disclosed in the recent release of its phase 3 clinical trials of the successive administration of three-drug compounds.
At the 58th European Association for the Study of Diabetes (EASD) conference in Stockholm in September, Dong-A ST unveiled the results of phase 3 clinical trials of three-drug compounds by adding evogliptin to the two-drug compound. The company made a similar release at the International Congress of Diabetes and Metabolism (ICDM) in Seoul this month.
Earlier, the company conducted a phase 3 clinical trial by administering evogliptin once daily in 283 type-2 diabetes patients with insufficient blood sugar control despite taking metformin and dapagliflozin.
Considering this, Sugadapamet, the other of the two trademarks for which Dong-A ST applied for patents, seems to be the name of the three-drug compound that added metformin, a component of the primary diabetes treatment, to the two-drug compound of evogliptin and dapagliflozin.
However, it is not certain when the company applied for the approval of the three-drug compound because it has yet to win the nod for the two-drug compound. Dong-A ST also expressed a position that it was too early to discuss the patent application for its three-drug compound.
Industry watchers said now that the discussion is going on whether to provide insurance benefits for the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors, Dong-A ST might be contemplating the time for its application for approval and the consequent launch of the product.
“Three-drug compounds as a diabetes treatment have yet to receive insurance benefits. However, many companies are conducting clinical trials to develop three-drug diabetes treatments,” an industry executive said on Tuesday. “The medical community must be paying attention to the discussion on their reimbursement requests.”
In September, Chong Kun Dang became the first company that applies for the approval of the three-drug diabetes treatment, CKD-393.
Chong Kun Dang plans to release its three-drug compounds – the addition of metformin to sitagliptin, a component of its DPP-4 inhibitor Duvie, and lobeglitazone of the thiazolidinedione (TZD) family -- called Duviemet S Tab.
The company said it seeks to put the product on the domestic market after September 2023.