The Hindu Business Line : Wockhardt to begin human trials on new compound

The Mumbai-based pharma company today informed BSE that it had received approval from the Drug Controller General of India (DCGI) to conduct Phase I clinical trials on its new Chemical entity, WCK 1152.

Wockhardt's chairman Mr Habil Khorakiwala had said in the past that this compound was efficacious against the multi-drug resistant pneumococcal bacteria. Apparently, pre-clinical studies had indicated the molecule had great potential in the treatment of upper and lower respiratory tract infections such as sinusitis, bronchitis, pharyngitis, community-acquired pneumonia and otitis media.

Wockhardt has developed oral and intravenous formulations of the product, according to company officials. Other drugs used at present in the management of respiratory ailments include amoxycillin, augmentin, erythromycin, azithromycin, gatifloxacin, levofloxacin and clarithromycin, many of them billion dollar products, officials said.

According to Wockhardt, the company was the first Indian to file an Investigational New Drug for an anti-infective in 2001. The global anti-infective market is valued at over $35 billion. Further, they point out that even as infections are increasingly becoming resistant to existing drugs, the pharmaceutical pipeline in anti-bacterials has been drying up.

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