Wockhardt files investigational application
By Nisha Das | 15 Nov 2001
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.
