Monday, August 15, 2011

Ozone to commence phase I trial of topical diabetic retinopathy medication

New Delhi - based pharmaceutical company Ozone Pharmaceuticals is developing a new molecule for diabetic retinopathy with the brand name 'OSIL'. Ozone Pharma has received a patent for th emolecule after animal testing and is now seeking an international tie up for a phase I clinical trial. The company is expecting to launch this product in late 2012.

This is a new invention by Ozone Pharma of a pharma composition for treatment of diabetic and non-diabetic ocular neovascular complications cataract and glaucoma. The composition of the new molecule comprises an active ingredient, selected from calcium benzene sulfonate salt compounds, and pharmaceutically acceptable excipients. Talking about the new innovation, SC Sehgal, Chairman and Managing Director said, “The need for a product which can prevent cataract as well as diabetes retinopathy is high because this has immense need worldwide. We had begun research and development of OSIL six to eight months back at AIIMS, New Delhi but the actual work was on for last four years.” The AIIMS study found administration of OSIL (Calcium dobesilate: one per cent w/v) as a topical medication in the form of eye drop to be an appropriate mode for long term administration for the slow processing disease like cataract. The study demonstrated that Calcium Dobesilate (CDO) in the form of topical administration is safe and expected to decrease systemic exposure.

He continued, “Now we are looking for alignment and seeking a approval from the regulatory body for phase I clinical trial. For phase I clinical trial we are looking for an agreement. The core reason behind international tie up is, to launch this product globally at an appropriate time.”

The company is diversifying into more specialised formulations like dentistry, neurology and gynaecology. Presently it has seven-eight new products at different stages of completion. Sehgal reveals the product launch details saying, “The products which we have planned to introduce in the Indian market are under evaluation and will take nearly 1.5 years for clinical trial. We plan to launch these products by end of next calender year.” The company plans to hire nearly 300-400 people adding to the existing headcount of 1200 by 2012. Sehgal said, “We are open to grow inorganically but predominately from organic way. We are also considering geographical expansion among SAARC nations.”

With a total turnover of Rs. 150 crore, it is targeting to take this figure to Rs. 1000 by 2016.