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Wednesday, May 15, 2002

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Ranbaxy's new molecule eyes hospital infections

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RANBAXY Laboratories Ltd (RLL) has filed an Investigational New Drug (IND) application for its molecule — Ranbezolid (RBx 7644) — with the Drug Controller-General of India (DCGI) to target hospital-acquired infections.

This would be the third IND being filed by RLL's New Drug Discovery Research group - the first compound being for the treatment of BPH (RBx 2258) which is undergoing Phase II trials.

The second compound for the treatment of bronchial asthma (RBx 7796) is awaiting DCGI's clearance for the commencement of Phase I trials.

Ranbezolid, an extended spectrum Oxazolidinone, is touted to be the second anti-bacterial molecule of the said group of compounds on a global level, according to an RLL press release issued here today.

However, it is the first to go into clinical investigations with an extended spectrum of activity, in the solid and injectable form, according to RLL.

Putting the significance of the IND molecule in perspective, the company observed that in the last two decades, multi-resistant gram-positive bacteria have become the dominant cause for hospital infections.

It is increasingly being seen in multi-centric studies in different continents that the gram-positive bacteria is not only more frequently isolated, but is increasingly becoming resistant to available drugs.

The growing presence of multi-resistant strains has led to an increase in infection-related morbidity, besides cost of care.

Against this backdrop emerged the clinical development and FDA approval of Linezoid in 2000, the first Oxazolindinone, from Pharmacia Upjohn. The extended spectrum Oxazolidinone was worked upon by Ranbaxy scientists and RBx 7644 exhibits good activity against significant gram-positive pathogens.

In the pre-clinical tests, RBX 7644 had shown significant safety advantages too, the note said.

And against the backdrop of the pre-clinical results and the predilection of the target bacteria that causes hospital infections, Ranbezolid can be suitable for treatment of hospital-acquired infections such as pneumonia, bacteriaemia, post-operative wound infection, skin and soft tissue infections, catheter or prosthesis and anaerobic infections caused by gram negative bacteria.

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Ranbaxy's new molecule eyes hospital infections

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