Biocon Partners With CytoSorbents to Market CytoSorb(R) -- A 'First-in-Class' Therapy for Sepsis Management

Biocon Partners With CytoSorbents to Market CytoSorb(R) -- A 'First-in-Class' 
Therapy for Sepsis Management 
BANGALORE, INDIA -- (Marketwired) -- 09/13/13 --  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(R), a novel therapy for the management of sepsis.  
CytoSorb(R) 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(R) 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(R) 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(R) 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 mi
llions of patients in our country."  
Rakesh Bamzai, President Marketing, Biocon Ltd, expressed:
"CytoSorb(R) 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(R), 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(R)
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(R) as we share the same
commitment to help patients with sepsis, and other life-threatening
conditions. We expect adoption and sales of CytoSorb(R) 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(R), 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(R) 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.  
About Biocon  
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(R), Glargine, BASALOG(R) and India's first biologic
BioMAb-EGFR (TM) 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(TM) 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(R), 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(R) 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 inf
ormation is available for download on the Company's
website: http://www.cytosorbents.com. 
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. 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(R) in India and select emerging markets,
acceptance of CytoSorb(R) 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.  
For further information: 
Media Contacts:  
Seema Ahuja
Head-Corporate Communications
Biocon Limited
T: +91-80-2808-2222
M:+919972317792
Email: seema.ahuja@biocon.com 
Phillip Chan, MD, PhD
Chief Executive Officer and President 
CytoSorbents Corporation
7 Deer Park Drive, Suite K
Monmouth Junction, NJ 08852 USA
Tel: +1-732-329-8885, Ext: *823
Email: pchan@cytosorbents.com 
Business Contacts: 
Rajesh Venugopalan
Business Development & Licensing - Critical Care
Biocon Limited
T: +91-80-67751134
M:+91-9731799882
Email: rajesh.venugopalan@biocon.com 
Chris Cramer, MS, MBA
Vice President of Business Development
CytoSorbents Corporation
Tel: +1-732-329-8885, Ext: *835
Email: ccramer@cytosorbents.com 
 
 
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