Expands upon Biocon’s successful commercialization of CytoSorb in India and leverages its substantial commitment to the Malaysian market

MONMOUTH JUNCTION, N.J., Feb. 15, 2018 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the expansion of its strategic partnership with Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, for the distribution of CytoSorb® in Malaysia. CytoSorb, approved in the European Union (E.U.) and distributed in 45 countries worldwide, is CytoSorbents’ unique whole blood cytokine adsorber designed to reduce “cytokine storm” and other excessive mediators that drive a deadly inflammatory response in common life-threatening conditions seen in the intensive care unit (ICU) and during complex cardiac surgery. Examples include sepsis, Dengue fever, and trauma with head injury – the leading causes of ICU admission in Malaysia.

CytoSorbents Logo. (PRNewsFoto/CytoSorbents)

Under the terms of the agreement, Biocon has exclusive rights to distribute CytoSorb in Malaysia, where CytoSorb is already registered. Similar to its approach in India, Biocon will assign a dedicated team in Malaysia to lead the market introduction and commercial development of CytoSorb.

Dr. Phillip Chan, Chief Executive Officer and President of CytoSorbents, stated, “We are very pleased to expand our relationship with our excellent long-term partner, Biocon. Biocon’s significant positive experience with CytoSorb, allocation of dedicated resources to support the partnership, and deep commitment to the Malaysian market make them the perfect choice to lead the CytoSorb rollout in Malaysia.”

Mr. Chris Cramer, Vice President of Business Development at CytoSorbents said, “Biocon’s results to date with CytoSorb have been truly impressive. Biocon understands what it takes and has the physician networks and commercial capabilities to successfully launch CytoSorb and quickly scale the business in Malaysia. With CytoSorb positioned well in India, the timing is right to take this next important step in growth.”

Financial terms of the agreement were not disclosed.

Critical Care and Biocon in Malaysia

With a population of 31.2 million people and a heavy burden of sepsis and other critical illnesses, Malaysia represents an attractive market opportunity for CytoSorb. According to the Malaysian Registry of Intensive Care, Ministry of Health Malaysia, dengue infection, sepsis, and head injury were the three most common diagnoses leading to ICU admission in MOH hospitals in 2015. The in-hospital mortality rates for this group of patients were 8.9%, 51.2% and 22.0% respectively.

Biocon Sdn. Bhd. (Biocon Malaysia) has established Asia’s largest integrated insulin manufacturing facility at the Biotech Park in Johor, Malaysia, with an investment of approximately $275 million, the highest foreign investment in Malaysia’s biotech sector to date. Biocon Malaysia is the first overseas biopharmaceutical manufacturing and research facility of Biocon Ltd and employs nearly 600 professionals at this state-of-the-art facility. Biocon Malaysia’s facility, which was commissioned in 2015, started commercial operations in 2017.

About the Biocon and CytoSorbents Partnership

CytoSorbents and Biocon entered into a strategic partnership in September 2013, under which Biocon was appointed as the exclusive commercialization partner for CytoSorb in India and select emerging markets. Since then, Biocon has successfully developed the critical care market for CytoSorb in India, with many successful treatments in numerous clinical applications such as sepsis, trauma, lung injury, influenza, and Dengue fever. In addition, CytoSorb has been used on patients undergoing cardiopulmonary bypass during cardiac surgery, and in conjunction with ECMO, or ExtraCorporeal Membrane Oxygenation, therapy. Also, CytoSorb has been used to successfully help bridge patients with acute hepatic failure to liver transplantation. Biocon and CytoSorbents are now extending this partnership to new, strategic markets like Malaysia.

About Biocon

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from ‘Lab to Market’. Some of its key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab), KRABEVA® (Bevacizumab) and ALZUMAb™ (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. The Company has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin. For more: http://www.biocon.com/ Follow-us on Twitter: @bioconlimited

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 45 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents recently initiated its pivotal REFRESH (REduction in FREe Hemoglobin) 2 trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 35,000 human treatments to date.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $22 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology, protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

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. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 3, 2017, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CytoSorbents Contact:
Amy Vogel
Investor Relations
[email protected]

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
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Public Relations Contact:
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Rubenstein Public Relations
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SOURCE CytoSorbents Corporation