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Venus gets DCGI nod for new therapy phase III trial for treatment of APE, Cystic Fibrosis
Our Bureau, Mumbai | Monday, February 19, 2007, 08:00 Hrs  [IST]

Venus Remedies Ltd has received permission from the Drug Controller General of India (DCGI) for conducting phase III clinical trials of the R&D product for treatment of Acute Pulmonary Exacerbation (APE) and Cystic Fibrosis, developed by its R&D wing.

The company has received the permission for conducting multi-centred clinical trials for this new therapy, sure to provide the necessary relief to the APE patients across the globe. The new formulation, a fixed dose combination drug of latest generation Cephalosporin with an Amino-glycoside, has been immediately put on clinical trials at centres across India immediately after receiving this permission.

This product will be the only solution for the treatment of life threatening infections caused by Pseudomonas. Aeruginosa MRSA in Cystic Firbrosis patients, thus helping in increasing their life span and would be launched for the first time in the world by the company, targeting a market worth US $2.5 billion world wide.

The formulation shall be ready for commercial launch in India by the last quarter of 2007. The IPR wing of the company has already filed the Indian patent and PCT application for this sure shot therapy, as the product will be launched for the first time globally.

The company is in an advanced stage of negotiations with some giants of Indian pharmaceutical industry, for the right placement of this product in the market.

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