Biocon Ltd, and CytoSorbents Corporation of US have inked an initial distribution agreement for India and select emerging markets, under which the former will have the exclusive commercialization rights for CytoSorb, a novel therapy for the management of sepsis. Financial terms of the agreement were not disclosed. The announcement coincided with the World Sepsis Day, observed annually on September 13.

CytoSorb is a safe and effective extracorporeal cytokine filter, designed to target the prevention or treatment of organ failure which is the cause of nearly half of all deaths in the intensive care unit.  If left unchecked, ‘cytokine storm’ caused by excessive cytokine production can cause massive inflammation, organ failure and death in common life-threatening conditions such as sepsis, burn injury, trauma, lung injury, and pancreatitis.  The drug  has CE Mark regulatory approval, and is clinically proven to control cytokine storm in critically-ill patients by reducing key cytokines in blood by 30-50 per cent. It also works easily with standard dialysis machines used in hospitals.

Biocon and CytoSorbents will initially focus on the treatment of sepsis - the end result of an excessive immune response to infection. The treatment needs to address the infection and the over-activation of the immune system.  By combining Biocon’s critical care antibiotics to treat the infection that are also compatible with CytoSorb therapy to modulate the immune response,.

 

“CytoSorb is a ‘first-in-class’ therapy that can provide an effective solution to physicians to treat critically ill patients suffering from sepsis. This move reflects our commitment to bring differentiated products to India that will help address various healthcare challenges faced by millions of patients, stated Kiran Mazumdar Shaw, chairperson & managing director, Biocon Ltd.

According to Rakesh Bamzai, president marketing, Biocon Ltd, “CytoSorb is a safe and well–tolerated innovative therapy for managing cytokine.  Very high levels of cytokines are known to cause multiple organ failure,. Through CytoSorb, we offer a promising treatment option to high risk patients in their fight against sepsis. We are confident that this will be a revolutionary tool for critical care specialists in sepsis treatment.”

Dr. Phillip Chan, CEO & president, CytoSorbents,  said, that unlike  any other previous approach, CytoSorb attacks sepsis from multiple angles – reducing cytokine storm, reducing many deadly bacterial toxins, and directing immune cells to target the infection while avoiding damage to otherwise healthy organs.  When combined with Biocon’s critical care antibiotics, it is an ideal broad spectrum strategy to fight sepsis.

Chris Cramer, vice president of business development, CytoSorbents stated, that   Biocon’s network will enable rapid access, education, training, and support of physicians in the largest hospitals throughout India and other emerging markets and our work will lay the groundwork for an expanded partnership in the future.”

Severe sepsis and septic shock are major causes of morbidity and mortality worldwide.  It is a leading cause of death in non-coronary ICUs and the 11th leading cause of death overall.  Over a third of patients with  sepsis succumb , even with  best  care. In India, over one million new cases of severe sepsis are treated in the Indian ICUs each year, accounting for one out of every four patients in the ICU.  According to a recent REPORT  of Indian ICU Mix and Practice Patterns (INDICAPS) involving over 124 ICUs across 17 states in India, mortality was 46% in patients with septic shock and 42.2 per cent overall in septic cases, compared with 17.8 per cent mortality for ICU patients without sepsis.