Balaglitazone (DRF 2593) the new drug candidate of Dr Reddy's Laboratories will shortly enter phase III trials. The drug is being developed in collaboration with Rheosciences, Denmark for type 2 diabetes.

Currently drug is being tried for carcinogenecity in animal models before commencing phase III trials. Carcinogenecity studies have been completed on one animal species and the studies on another species is awaited, GV Prasad, vice-chairman and chief executive officer, Dr Reddy's Laboratories told Pharmabiz.

The addition of Balaglitazone, a partial PPAR-gamma agonist, would expand the treatment options available to the physicians globally for management of type 2 diabetes. The PPAR class of drugs are of major clinical relevance and have the potential to address important unmet needs of the millions of patients suffering from various metabolic disorders, including diabetes worldwide.

Dr Reddy's entered into an agreement with ClinTec International, UK, during the end of September 2006 for the joint development of an anti-cancer compound, DRF 1042, belonging to the Topoisomerase inhibitors class of compounds for use as potential treatment of various types of cancer.

Dr Reddy's has completed phase I clinical trials for DRF 1042 in India. Under the terms of the agreement, Dr Reddy's and ClinTec will co-develop DRF 1042; undertaking phase II and phase III clinical trials, with the aim of securing US FDA and EMEA approvals.

Dr Reddy's has also improved its regulatory filings. It has filed three US DMFs during the second quarter of current fiscal taking the total filings to 86. The company also filed three DMFs in Canada. The company has filed eight ANDAs, including three non Para IVs, during the second quarter of current financial year, taking the total ANDAs pending at US FDA to 56, addressing a market opportunity in innovator sales of $61 billion, Satish Reddy, managing director and COO, Dr Reddy's, said.

The company's international revenues are growing significantly. It has achieved consistent year-on-year growth in API and Branded Formulations for the last five quarters. The company is witnessing increasing portfolio of new products driven by patents expiries in major markets.

The company is making strides in the branded formulations internationally with Russia being one of the key growth markets. Ukraine, Uzbekistan, Venezuela and Romania also are showing growth. Revenues from Authorised Generics (AG) are contributing a significant portion of the overall generics revenues in North America, Satish Reddy added.

Dr Reddy's is also making steady efforts to expand its infrastructure capabilities to meet future growth. The company has recently obtained in-principle approvals for two SEZs each focusing on bulk drugs and formulations. These SEZs will also cater to the needs of its growing Custom Pharmaceutical Services (CPS) business.

In principle approvals were given to Dr Reddy's to establish pharma SEZs in Medak and Srikakulam Districts of Andhra Pradesh where the company is expecting to make substantial investments. The company will soon initiate work on the proposed SEZs and in three years time there can be significant progress in this direction, Satish Reddy informed.