SEOUL, South Korea I October 2, 2015 I Dong-A ST Co., Ltd. announced on October 2 that the MFDS (Ministry of Food and Drug Safety) has approved the NDA of SUGANON (Code Name: DA-1229, Evogliptin 5mg tablet) for type 2 diabetes mellitus.
SUGANON is a new oral anti-hyperglycemic agent of the DPP-4 (dipeptidyl peptidase-4) inhibitor class developed by Dong-A ST and its generic name, Evogliptin, came from the combination of “Evo-lution” and “Gliptin”, which means evolved gliptin with strong points of the existing DPP-4 inhibitors.
According to IMS data, worldwide oral anti-diabetic market is 21.1 billion USD and DPP4 inhibitors, with sales of 12.6 billion USD, takes 60% of worldwide oral anti-diabetic drug market. In Korea, similar-ly DPP4 inhibitor market is 217 million USD, 57% of total oral anti-diabetic drug sales of 383 million USD.
SUGANON is a 5mg once-daily tablet for the treatment of type 2 diabetes mellitus in patients inade-quately controlled by diet and exercise alone, or in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycemic control. SUGANON can be taken regardless of meal intake as the absorption of SUGANON is not influenced by food intake. SUGANON is highly potent and does not need dose adjustment in patients with renal insufficiency.
Also, SUGANON has a low potential for interaction with other co-administered drugs, which can be helpful to improve convenience and compliance in patients taking multiple medications for chronic dis-eases.
Mr. Chan-il Park, CEO of Dong-A ST, said “SUGANON is the 5th new drug of in-house assets, follow-ing Stillen, Zydena, Motilitone and Sivextro, which demonstrates our great R&D capabilities”.
Also, considering that DPP-4 inhibitors are frequently prescribed in combination with metformin, Dong-A ST has been developing fixed-dose combination tablets of evogliptin and extended-release (XR) metformin and submitted an NDA of it to the MFDS this June. SUGANON and XR combination tablets with different dose strength of metformin will provide patients and physicians with a wider range of therapeutic options and increase convenience.
Dong-A ST already signed license-out agreements with Luye Pharma Group for China, Alkem Labora-tories Ltd. for India and Nepal, respectively in 2012. Dong-A ST made a license-out agreement with Eurofarma Laboratórios S.A for the territory of Brazil in 2014 and signed an additional license-out agreement for 17 countries in Latin America in 2015. Recently, Evogliptin has also licensed to Gero-pharm for the Russian and other CIS markets (Ukraine, Kazakhstan). The NDA approval of Evogliptin will be a momentum to expand its global reach.
SOURCE: Dong-A ST
Post Views: 45
SEOUL, South Korea I October 2, 2015 I Dong-A ST Co., Ltd. announced on October 2 that the MFDS (Ministry of Food and Drug Safety) has approved the NDA of SUGANON (Code Name: DA-1229, Evogliptin 5mg tablet) for type 2 diabetes mellitus.
SUGANON is a new oral anti-hyperglycemic agent of the DPP-4 (dipeptidyl peptidase-4) inhibitor class developed by Dong-A ST and its generic name, Evogliptin, came from the combination of “Evo-lution” and “Gliptin”, which means evolved gliptin with strong points of the existing DPP-4 inhibitors.
According to IMS data, worldwide oral anti-diabetic market is 21.1 billion USD and DPP4 inhibitors, with sales of 12.6 billion USD, takes 60% of worldwide oral anti-diabetic drug market. In Korea, similar-ly DPP4 inhibitor market is 217 million USD, 57% of total oral anti-diabetic drug sales of 383 million USD.
SUGANON is a 5mg once-daily tablet for the treatment of type 2 diabetes mellitus in patients inade-quately controlled by diet and exercise alone, or in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycemic control. SUGANON can be taken regardless of meal intake as the absorption of SUGANON is not influenced by food intake. SUGANON is highly potent and does not need dose adjustment in patients with renal insufficiency.
Also, SUGANON has a low potential for interaction with other co-administered drugs, which can be helpful to improve convenience and compliance in patients taking multiple medications for chronic dis-eases.
Mr. Chan-il Park, CEO of Dong-A ST, said “SUGANON is the 5th new drug of in-house assets, follow-ing Stillen, Zydena, Motilitone and Sivextro, which demonstrates our great R&D capabilities”.
Also, considering that DPP-4 inhibitors are frequently prescribed in combination with metformin, Dong-A ST has been developing fixed-dose combination tablets of evogliptin and extended-release (XR) metformin and submitted an NDA of it to the MFDS this June. SUGANON and XR combination tablets with different dose strength of metformin will provide patients and physicians with a wider range of therapeutic options and increase convenience.
Dong-A ST already signed license-out agreements with Luye Pharma Group for China, Alkem Labora-tories Ltd. for India and Nepal, respectively in 2012. Dong-A ST made a license-out agreement with Eurofarma Laboratórios S.A for the territory of Brazil in 2014 and signed an additional license-out agreement for 17 countries in Latin America in 2015. Recently, Evogliptin has also licensed to Gero-pharm for the Russian and other CIS markets (Ukraine, Kazakhstan). The NDA approval of Evogliptin will be a momentum to expand its global reach.
SOURCE: Dong-A ST
Post Views: 45
