Jubilant's molecule gets FDA approval for drug trials

The US Food & Drug Administration (FDA) accepted the novel molecule of the Bangalore-based Jubilant Biosys Ltd for clinical trials to treat prostate cancer, the pharma company said Saturday.

"The FDA acceptance of our investigational new drug relates to the new molecule targetting prostate cancer. Approval of our filing paves way for the next stage of development and clinical trials later this year," Jubilant drug discovery services president Subirkumar Basak said in a statement here.

As a subsidiary of the pharma major Jubilant Life Sciences, Biosys provides integrated drug discovery solutions to pharma firms worldwide.

The drug trials will be conducted in collaboration with the US-based Endo Pharmaceuticals Ltd.

"Being at the forefront of pharmaceutical, life sciences and healthcare innovation, we pursue our goal to enable affordable healthcare to patients worldwide," Basak said.

The filing and progression of the molecule to the next development stage also validates Endo's collaborative drug discovery approach to improve patient outcomes.

"Our multi-target oncology collaboration with Jubilant, which began four years ago, is focused on developing therapies that address the unmet needs of cancer patients worldwide," Endo's discovery & early development vice-president Sandeep Gupta said in the statement.

Biosys pioneered the risk-shared collaborative discovery research model and demonstrated its capability through partnerships with global pharmaceutical firms in the therapeutic areas of oncology, metabolic disorders, pain and inflammation.