Topoisomerase inhibitors are an established class of anticancer agents with a mechanism of action aimed at interrupting DNA replication in cancer cells, the result of which is cell death. A commonly prescribed class of topoisomerase inhibitors are fluoroquinolones.
The drug candidate, DRF 1042, has been designed to specifically target breast, ovarian and colorectal cancer and has shown significant potential in Phase I clinical trials, which Dr Reddy's have already carried out in India.
Under the terms of the agreement, ClinTec International will lead the clinical development of DRF 1042 including undertaking all regulatory work with the aim of securing USFDA and EMEA approvals as fast as possible. Phase II clinical trials in Europe are currently being planned.
ClinTec International will be granted the commercialisation rights for all major European markets. Dr. Reddy's retains the commercialisation rights for the US and rest of the world markets.
On commercialisation of the product, Dr. Reddy's will receive royalty on sales by ClinTec International in its designated territories and ClinTec International will receive royalty on sales by Dr. Reddy's in the US
Dr. Reddy's will also retain the exclusive rights to supply commercial quantities of the drug product. Financial details of the agreement have not been disclosed.
"We are delighted to be working with Dr Reddy's, which has a strong reputation in the global pharmaceutical industry. We are impressed with the quality and commitment of Dr Reddy's clinical research staff with whom we have worked for sometime and we are proud to build on our existing relationship with this company," said Dr Rabinder Buttar, President & CEO of ClinTec International.
"We are also proud that ClinTec International's expertise and experience in clinical drug development has been recognised by Dr Reddy's and we look forward to a mutually beneficial long term collaboration."
Topoisomerase inhibitors constitute a major class of anticancer drugs and are among the most widely clinically used anticancer drugs for many types of cancers. There is currently a strong need for new, improved topoisomerase inhibitors.
Dual inhibitors of topoisomerase I and II have been shown to have therapeutic advantages over single enzyme inhibitors, including sensitivity in resistant cells, more potent activity, and a broader spectrum of activity.
"This innovative approach to co-development truly leverages the strengths of both parties, and allows ClinTec and Dr Reddy's to share the financial risks and benefits of developing an exciting oncology compound," said Director of Corporate Development at ClinTec International, Bobby Bal.
"We look forward to continuing our track record of clinical work with Dr Reddy's, and as partners I believe the organisations are well placed to bring DRF 1042 to the market in the shortest possible timeframe."