BANGALORE, INDIA--(Marketwired - September 13, 2013) - Biocon Ltd, Asia's largest biotech company, and CytoSorbents Corporation (OTCQB: CTSO), based in the United States, announced today, World Sepsis Day, that they have entered into a strategic partnership with an initial distribution agreement for India and select emerging markets, under which Biocon will have the exclusive commercialization rights for CytoSorb®, a novel therapy for the management of sepsis.
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. CytoSorb® 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%. 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 effective treatment of sepsis needs to address two components -- 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, the two companies will be providing the most comprehensive solution for sepsis management in the market.
Kiran Mazumdar Shaw, Chairperson & Managing Director, Biocon Ltd, said, "We believe our partnership with CytoSorbents will enable us to address the huge unmet need of sepsis management in India and emerging markets. 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 in our country."
Rakesh Bamzai, President Marketing, Biocon Ltd, expressed: "CytoSorb® is a safe and well-tolerated innovative therapy for managing cytokine storm in critically ill patients. Very high levels of cytokines are known to cause multiple organ failure, which is often life threatening. Through CytoSorb®, we offer a promising treatment option to high risk patients in their fight against sepsis and other critical illnesses. We are confident that this will be a revolutionary tool for critical care specialists in sepsis treatment."
Dr. Phillip Chan, Chief Executive Officer and President, CytoSorbents, said, "We are very pleased to enter into this initial agreement with Biocon on World Sepsis Day and to bring our potentially life-saving therapy to the people of India and other emerging markets. 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. Biocon is a perfect partner for CytoSorbents and CytoSorb® as we share the same commitment to help patients with sepsis, and other life-threatening conditions. We expect adoption and sales of CytoSorb® to benefit from Biocon's strong regional sales and distribution network across India, and extensive equity with key opinion leaders."
Mr. Chris Cramer, Vice President of Business Development, CytoSorbents, stated, "Biocon is an exceptionally strong partner for CytoSorbents with expertise in introducing innovative new therapies, like CytoSorb®, into the hospital setting. Biocon's network will enable rapid access, education, training, and support of physicians in the largest hospitals throughout India and other emerging markets. We are very excited to be working with a leader like Biocon and look forward to supporting them in the successful launch of CytoSorb® in these markets. This partnership has the potential to change the treatment of critical care illnesses such as sepsis, and we are confident that our work will lay the groundwork for an expanded partnership in the future."
Financial terms of the agreement were not disclosed.
About India and Sepsis
India is the second most populous country in the world with over 1.2 billion people and the tenth largest economic market by gross domestic product (GDP). By 2015, India is also projected to be the 10th largest market for pharmaceuticals and medical devices, with over $25 billion in forecasted sales.
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 who develop sepsis die globally, even though the best standard of care is available. In India, more than one million estimated 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 nationwide study of Indian Intensive Care Case Mix and Practice Patterns (INDICAPS) involving over 124 ICUs across 17 states in India, mortality was found to be as high as 46% in patients with septic shock and 42.2% overall in septic patients, compared with 17.8% mortality for ICU patients who did not develop sepsis.
Established in 1978, Biocon Limited, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest and Asia's leading biotechnology company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide. Biocon's robust product portfolio includes the world's first Pichia-based recombinant human Insulin, INSUGEN®, Glargine, BASALOG® and India's first biologic BioMAb-EGFR ™ for head & neck cancer. It has now successfully developed its second novel biologic Itolizumab, a 'first in class' anti-CD6 monoclonal antibody, introduced as Alzumab™ for psoriasis in India, in 2013. Visit: www.biocon.com
About CytoSorbents Corporation
CytoSorbents Corporation (OTCQB: CTSO) is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. CytoSorb®, the Company's flagship product, is approved in the European Union as a safe and effective extracorporeal cytokine filter, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. CytoSorb® also removes myoglobin from blood, making it a potential treatment of rhabdomyolysis in trauma. These are conditions where the mortality is extremely high, yet no effective treatments exist.
Additional information is available for download on the Company's website: http://www.cytosorbents.com.
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated, including the successful registration of CytoSorb® in India and select emerging markets, acceptance of CytoSorb® by physicians, and other factors. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. Risk factors are detailed in the CytoSorbents' Form 10-K filed with the SEC on April 3, 2013, which is available at http://www.sec.gov.