Wockhardt files investigational application

Mumbai: Domestic pharmaceutical major Wockhardt has filed an investigational new drug application with the Drugs Controller General of India for its new chemical entity, WCK-771, in the anti-ineffective segment. Workhardt is the first Indian pharma company to file for an investigational new drug application.

The company had initiated its NDD programme around four years back and its new proprietary compound WCK-771, discovered as the first Indian anti-bacterial, provides a broad spectrum of bactericidal activity against both gram positive and gram negative pathogens including methicillin resistant staphylococcus aureus and vancomycin and glycopeptide intermediate staphylococcus aureus.

Says Wockhardt chairman Habil Khorakiwala: Wockhardt has taken the first vital step in the search for new drugs, and its NCE is the first Indian filing in Sepsis and in the anti-ineffectively field. This new proprietary compound of Wockhardt will be able to effectively treat some of the life-threatening and challenging infections such as Sepsis and no-socomial (hospital-acquired) infections. Because of its rapid cidal (lethal) action, even against the widely prevalent multi-drug resistant MRSA and VISA /GISA strains, it will address the unmet medical needs of physicians and surgeons. We have also filed patent applications for WCK-771.

In pre-clinical experimental studies, Wockhardts WCK-771 has shown superior to the currently available anti-MRSA agents like Vancomycin, Teicoplanin, Synercid and Linezolid. What is noteworthy is that several pharmaceutical companies all over the world are striving to create favourable therapeutic options for treating infection due to MRSA, which pose life-threatening problems. Wockhardts WCK-771 filing is in the right direction, since it will not only find great usage in India but also have global potential, says Khorakiwala.

The global anti-infectives are estimated at over $35 billion, which is around 12 per cent of the total pharmaceutical market. Of this, drugs such as Vancomycin, Linezolid and other such anti-infectives used in treating resistant strains of bacteria constitute nearly $1.0 billion.