PATHOGEN INACTIVATION:

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1 PATHOGEN INACTIVATION: She s worth it. Be SURE. With INTERCEPT you know that you are doing everything in your power to deliver safe and effective blood products to patients.

2 Transfusion-transmitted infection remains a threat to patients receiving blood components during the course of their medical treatment. Testing fails to eliminate this risk and leaves patients vulnerable to Global emerging and re-emerging infectious diseases2 Vancomycin-resistant S. aureus Lyme disease Usutu Babesia Human monkeypox 1. The risk of bacterial contamination remains high despite the T. Cruzi T. Cruzi West Nile virus range of blood safety measures implemented to address it. 1 limitations to the existing testing methods. Lassa fever window periods and occult infections remain significant SARS E. coli O157:H7 E. coli O157:H7 a wide variety of known and unknown infectious threats. 2. Despite the addition of nucleic acid testing (NAT), Drug-resistant malaria Vancomycinresistant S. aureus Typhoid fever Hepatitis C H5N1 influenza Rift Valley fever HIV Nipah virus Hendra virus Enterovirus 71 Dengue Human monkeypox Yellow fever Cholera Marburg Chikungunya haemorrhagic fever Ebola haemorrhagic fever Adapted from Morens DM, et al. The challenge of emerging and re-emerging infectious diseases. Nature Jul 8;430(6996): Testing is an inherently reactive approach that can only be initiated after a threat has been identified. As a result, testing can never safeguard the blood supply from emerging and re-emerging pathogens: West Nile, Dengue and Chikungunya viruses are just a few examples. In addition to infectious threats, febrile non-hemolytic transfusion reactions are a daily threat for patients and thus a concern for transfusing physicians. Why are additional blood safety

3 Several patient groups run an increased risk of transfusion-transmitted infection due to the high number of blood components they receive for their treatment. Recent studies1 demonstrate that the residual risk of bacterial contamination for one platelet unit is still as high as 1 in 1,500 despite bacterial detection measures. When there A cancer patient undergoing bone marrow transplant, is a product for example, may need up to 120 units of platelets during on the market 3 transfusion support, resulting in an increased contamination risk of 1 in bacterial that produces safer blood components, we should use it. Frequently Transfused Patients A cancer patient undergoing bone marrow transplant may need up to 120 units of platelets during transfusion support.3 Thrombotic thrombocytopenic purpura (TTP) requires total plasma exchange, a treatment with up to 200 units of plasma. 4 measures needed? Sickle cell disease and thalassemia patients may be transfused with approximately 30 units per year, or over 1,000 units over a lifetime. 5 Dr. Emma Castro Medical Director & CEO, Spanish Red Cross, Spain.

4 Platelets Over the past 20 years, pathogen inactivation has demonstrated its value by improving safety in the plasma fractionation industry. In order to afford patients receiving labile blood components a similar level of protection, Cerus pioneered the development of pathogen inactivation for platelets and plasma using a single platform. The INTERCEPT Blood System has demonstrated the broadest inactivation spectrum against viruses, bacteria and parasites potentially causing transfusion transmitted diseases. The treatment also inactivates white blood cells. INTERCEPT s unique mechanism of action (MoA) results in cross-linking of nucleic acids, thus preventing replication, while retaining therapeutic efficacy of the blood components. The efficiency of cross-linking by INTERCEPT offers high levels of pathogen inactivation; 6 logs, or more than a million organisms are inactivated for most pathogens. The INTERCEPT technology is currently available for platelets and plasma and approved for use in all patients. INTERCEPT for red blood cells is in Phase III clinical development. Plasma RBC Shouldn t

5 PATHOGEN INACTIVATION: She s worth it. Intercept offers a huge gain in patient safety. And that s what healthcare is all about: the patients! Dr. F Knutson Medical Director, Uppsala University Hospital, Sweden this safety be her safety?

6 INTERCEPT is a better choice than bacterial screening in the range of measures for improving blood safety. Dragoslav Domanovic, MD, PhD Director, BTC Ljubljana, Slovenia With INTERCEPT we have changed the processes of the past to build the blood bank of the future. Prof. Jean-Daniel Tissot Director SRTS VD Lausanne, Switzerland The efficiency of inhibiting the replication of T-lymphocytes is much greater with INTERCEPT than with gamma irradiation. Dr. Emma Castro Medical Director & CEO, Spanish Red Cross, Spain INTERCEPT Regulatory Approvals CE mark, Class III (platelets), 2006 (plasma) France (Afssaps) - platelets and plasma Germany (PEI) * (platelets), 2011* (plasma) Switzerland (Swissmedic) - platelets and plasma Austria (AGES) * (platelets) * First blood center marketing authorization approved. Shouldn t this

7 The INTERCEPT blood system is used routinely in over centers in 15 countries. INTERCEPT kits sold to date could produce almost a million units for transfusion. The INTERCEPT Blood System for platelets and plasma is CE marked in accordance with requirements of the EU Medical Device Directive. Some countries require additional local approvals of treated platelets and plasma, similar to standards for biologic products (see list on previous page for these additional INTERCEPT approvals). Multiple phase III/IV randomized controlled clinical safety 80 efficacy trials have demonstrated its and. An extensive and unique hemovigilance database with over 60,000 transfusions has demonstrated safety and reliability in routine use. Rapid nationwide Swiss implementation of INTERCEPT confirms its operational ease. Further, implementation on the French islands of Martinique, Guadeloupe and Ile de La Réunion in response to local Dengue and Chikungunya virus epidemics 6 demonstrates the overall utility of the system in securing the safety and availability of the blood supply. Bacterial contamination of platelet concentrates remains one of the major causes of fatal adverse events in blood transfusion, but is also one of the biggest preventable risks. Dr. Rudolf Schwabe CEO Blood Transfusion Services, Swiss Red Cross experience be your experience?

8 The improved logistics of platelets and plasma production with INTERCEPT reduces labor cost and increases product availability, yielding unexpected operational gains. The up to 7-day shelf life for platelets and the removal of redundant safety measures such as CMV testing, gamma irradiation, and bacterial detection help maintain products availability for patients in need. CERUS has optimized cost efficiency of the system by developing disposable sets that yield multiple units with a single kit. The ability to produce multiple units from each treatment allows for a meaningful reduction in consumables, labor and other production costs. This makes production more at less cost per unit produced. cost efficient Intercept: It s worth it.

9 PATHOGEN INACTIVATION: It s worth it. The rollout of INTERCEPT for both platelets and plasma was very easy and didn t require additional investments in the center. Prof. Jean-Pierre Cazenave, Director of EFS Alsace, Strasbourg, France

10 Nearly a decade of experience with customers from a wide range of countries with varying regulatory and production requirements has made CERUS an expert in validation procedures and production logistics. Customer feedback 96% of INTERCEPT users say that they would be very likely or quite likely recommend Cerus to their peers. Very likely Quite likely Neither likely nor unlikely Unlikely Not at all likely Can t comment CERUS employs highly trained and experienced implementation support staff committed to streamlining your implementation process. Cerus can help you realize added benefits for your blood center and the hospitals and patients you serve. A recent customer survey confirmed the high degree of customer satisfaction 2011 Customer Satisfaction Survey in 12 European & Middle-Eastern countries for INTERCEPT. CERUS is committed to you, your customers and

11 INTERCEPT may add cost to production, but it saves costs at other levels too. PATHOGEN INACTIVATION: He s worth it. their patients.

12 References: 1. Dumont LJ, et al. Screening of single-donor apheresis platelets for bacterial contamination: the PASSPORT study results. Transfusion Mar;50(3): Morens DM, et al. The challenge of emerging and re-emerging infectious diseases. Nature Jul 8;430(6996): Greeno E et al Platelet utilization and the transfusion trigger: a prospective analysis, Transfusion. 2007; 47: a) de Alarcon P, et al. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies. Transfusion Aug;45(8): b) Mintz PD, et al. Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease Blood May 1;107(9): Wahl S, Quirolo KC., Current issues in blood transfusion for sickle cell disease. Curr Opin Pediatr Feb;21(1): Review. 6. Rasonglès P, et al. Transfusion of platelet components prepared with photochemical pathogen inactivation treatment during a Chikungunya virus epidemic in Ile de La Réunion Transfusion Jun;49(6): Cerus Corporation. Cerus, INTERCEPT Blood System and INTERCEPT are trademarks of Cerus Corporation. MAN-EN-00098, v.1.0 Global Headquarters Cerus Corporation 2550 Stanwell Drive Concord, CA 94520, USA European Headquarters Cerus Europe B.V. Stationsstraat 79-D 3811 MH Amersfoort The Netherlands customer_services@cerus.com Use of INTERCEPT is contraindicated in patients with a history of allergic response to amotosalen or psoralens. No pathogen inactivation system has been shown to inactive all pathogens. Not approved for sales in the U.S.