Vildagliptin validation successfully completed
Infa Group is pleased to announce that the validation campaign of Vildagliptin has been successfully completed by Ulkar Kimya, Infa Group strategic ally.
Vildagliptin was developed at Labochim and, according to the below strategy , has been optimized and validated at our Turkish partner.
The relevant CoAs will be available end of November 2015 and the EDMF will be ready for filing end February 2016.
The DMF Holder will be INFA SA.
According to the Turkish patent expiry, INFA Group may sell commercial quantities to non regulated or patent free countries (among which Eastern European countries) from Turkey by 2019, which is about 3 years prior to Italy or Spain.
This strategy provides INFA Group unequivocal advantages. INFA Group will establish full scale commercial production capacities and thus will be capable of supplying early entry markets before the European launch (2022).
Vildagliptin (Novartis trade name Galvus, 50mg tablet) is an oral anti-hyperglycemic agent (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs.
Vildagliptin products are currently authorized in Europe, Australia and the RoW.
Daniele Cardoso, Chairman of INFA Group, commented: “ I congratulate on the joint R&D teams of Ulkar and Labochim, for these important results and the manner in which they have been obtained. This confirms the validity of our collaboration with Ulkar Kimya and the value of the technology “Made in INFA”.
About INFA and Ulkar Kimya
In 2012, INFA Group formed a strategic alliance with Ulkar Kimya, a company specializing in the manufacture of drug substance and coated micropellets, located in Tekirdag, Turkey and member of the Turkish Nobel Ilac Group.
This strategic alliance allows INFA Group:
– to improve Generic stockpiling capabilities and to expand the presence in “pharmemerging” markets through early launches of new product pipelines
– to enter the burgeoning Turkish market
– to cultivate regional markets such as CIS, Africa, Middle East
Together with Ulkar Kimya, INFA Group is able to strategize the R&D pipeline in full international compliance including current patent laws, and according to.