As part of the deal, the firm has to generate new clinical evidence
Biocon will have the exclusive rights to distribute CytoSorbents Corporation’s CytoSorb, which is used to treat severe body inflammation.
The Bangalore-based biotech major will market this in India and select emerging countries. However, the financial terms of the tie-up has not been disclosed.
This product is used to treat a condition called Systemic Inflammatory Response Syndrome (SIRS), which is caused by a range of life-threatening conditions seen in the intensive care unit and something that can also be caused by surgical interventions, particularly after or during cardiac surgery.
As part of the expanded agreement, Biocon will also play a prominent leadership role in the generation of new clinical evidence, which includes a commitment to conduct and publish results from multiple Investigator Initiated Trials, another word for clinical trials.
Treatments
Ravindra Limaye, President, Marketing, Biocon, said that this partnership with CytoSorbents will enable the company to address the unmet needs of patients experiencing a SIRS as a result of burns, lung injury, liver failure, pancreatitis, post-cardiac surgery complications, and tropical diseases such as malaria and dengue fever.
Abhijit Barve, President, Research & Development, Biocon added that physicians are increasingly identifying conditions where very high levels of cytokines are known to cause multiple organ failure.
“We also believe there is a significant unmet medical need to manage high-risk patients undergoing cardiac surgery by using CytoSorb to control inflammation,” he said.
The issue of conducting clinical trials has been under fire, as concerns have merged due to a lack of regulation of private trials and uneven application of requirements for informed consent and proper ethics review.
This resulted in the Indian government halting all clinical trials since October 2013, a fact which has hampered business for Indian pharmaceutical companies. Between 2005 and 2012, over 2,600 people died during clinical trials.
