How many pathogen inactivation systems for platelets and plasma are proven?

INTERCEPT Pathogen Inactivation

Front Cover

ONE pathogen inactivation system for platelets and plasma, Class III CE-marked

ONE technology that inactivates a broad spectrum of known and emerging viruses, bacteria and parasites

ONE accepted alternative to gamma irradiation, bacterial detection and CMV testing (1, 2) for platelets

ONE technology proven in routine use with over 600,000 transfusions

Enveloped Viruses•HIV-1/2•HBV•DHBV•HCV•BVDV•HTLV-I/II•CMV•LCMV(4)

•WNV•SARS-CoV•Vaccinia(5)

•Chikungunya•Dengue(6)

•InfluenzaAvirus

Non-Enveloped Viruses•Bluetonguevirus,type11•Felinecalicivirus•ParvovirusB19•Humanadenovirus5

Gram-Negative Bacteria• Klebsiella pneumoniae• Yersinia enterocolitica• Escherichia coli• Pseudomonas aeruginosa• Salmonella choleraesuis• Enterobacter cloacae• Serratia marcescens• Anaplasma phagocytophilum• Orientia tsutsugamushi (7)

Gram-Positive Bacteria• Staphylococcus epidermidis• Staphylococcus aureus• Streptococcus pyogenes• Listeria monocytogenes• Corynebacterium minutissimum• Bacillus cereus (vegetative)• Lactobacillus sp.• Bifidobacterium adolescentis• Propionibacterium acnes• Clostridium perfringens

Spirochetes• Treponema pallidum• Borrelia burgdorferi

Parasites• Trypanosoma cruzi• Plasmodium falciparum• Leishmania sp.• Babesia microti

Leukocytes

Broadest inactivation spectrum of known

and emerging pathogens

Helical region of DNA and RNA Replication blocked

Intercalation Crosslinking

Targeting

UVA Illumination Amotosalen

Detailed inactivation data is included in INTERCEPT technical data sheet available from www.INTERCEPTBloodSystem.com.

• Amotosalenpenetratescellularandnuclearmembranes,intercalatingintohelicalregionsofDNAorRNA.

• CovalentcrosslinkstonucleicacidbasepairsformuponexposuretoUVAlight.

• DNAandRNAreplicationareblocked,inactivatingpathogensandleukocytesandrenderingthemincapableofcausingdisease.

Table 1:

Phase I & II Trials Phase III Trials Haemovigilance Program

Platelets

4trials

43subjects

PrimaryEndpointsachieved

4trials/811patients

~3,700INTERCEPTunits

PrimaryEndpointsachieved

Over30,000transfusionsmonitored

Significantreductionintransfusion

reactionsobserved(1,3)

Plasma

3trials

42subjects

PrimaryEndpointsachieved

3trials/203patients

~5,000INTERCEPTunits

PrimaryEndpointsachieved

Over30,000transfusionsmonitored

INTERCEPT Blood System Mechanism of ActionRobust inactivation capability of known and emerging pathogens (viruses, bacteria, parasites) as well as leukocytes

Therapeutic Efficacy of INTERCEPT Platelets and Plasma is Fully RetainedDocumented by extensive pre-approval clinical trials and a rigorous active haemovigilance program

Left Flap (Inside)

• Eliminatestheneedfor:• GammairradiationforpreventionofTA-GVHD(CE-markedclaim)

• Bacterialscreeningtests• CMVtesting

• 7-daysplateletstorage,allowingforanextensionofplateletshelflifeandareductionintheplateletdiscardrate

• Treatmentofdoubledoseplateletswithasingledisposablesettooptimizeeconomics(upto7.0x1011)

• Largeplasmatreatmentvolumecapacity(upto650ml)

“…INTERCEPT gives us the confidence we’ve always looked for, in an easy-to-use method.”

Dr. Folke KnutsonMedical Director, Uppsala University Hospital, Sweden

“The logical choice for blood safety lies in pathogen inactivation, not bacterial screening.”

Dr. Jean-Claude OsselaerMedical Director, UCL Mont-Godinne, Belgium

“...when there is a product on the market that produces safer blood components, we should use it.”

Dr. Emma CastroMedical Director & CEO, Spanish Red Cross, Spain

>600,000 INTERCEPT Transfusions, and GrowingProven in routine use to be simple and convenient at over 60 centers in 14 countries. Enables key cost-savings.

Right Flap (Outside)

(Dualstoragecontainerkitconfigurationavailabilitydependingonlocalcountryregulations)

Add1

Inactivate2

Remove3

Ready to Use/Store4

Table 2: UVA Illuminator Hourly Throughputa

Platelet Units Plasma Units

40 36

a. Includespreparation,loadingandunloadingofUVAilluminator.Assumes2-unityieldfromeachplatelettreatmentand3-unityieldfromeachplasmatreatment.

INTERCEPT Blood System Process OverviewHigh throughput platelet and plasma processing, with fully integrated system

CollectedplateletsorplasmaaresterilelyconnectedtotheINTERCEPTsetbeforeprocessing.Amotosalen(1)isaddedbygravityflowandthemixtureisilluminatedbyUVAlight(2).Residualamotosalenanditsphotoproductsarereducedtolowlevelsusingacompoundadsorptiondevice(CAD)(3)beforetransfertostoragecontainer(s)(4).

INTERCEPT Platelet Set

UVA Illuminator

INTERCEPT Plasma Set

CAD StorageAmotosalen Illumination

1 2 3 4

CAD StorageAmotosalen Illumination

1 2 3 4

Inside Center

INTERCEPT Platelets & Plasma

• Compatiblewithapheresisandwholebloodcollections.

• Compatiblewithplateletconcentratesofupto7.0x1011plateletsstoredinadditivesolutionorplasma.

• Compatiblewithplasmainputvolumesfrom385to650mL.

Illuminator

• PowerSupply:110Vor230V,50Hz,3A• Measures:L115cm,H37cm,W74cm• Weight:69kg• Deviceisstackable(two-high)

Table 4: Processing Range Requirements for Platelets

Small Volume Set Large Volume Set Dual Storage Set

SuspensionMediumc PAS PAS Plasma PAS

PlateletCount 2.5–6.0x1011 2.5–7.0x1011 2.5–7.0x1011 2.5–7.0x1011

Volume 255–325mL 300–420mL 255–390mL 300–420mL

Plasma 32–47% 32–47% 100% 32–47%

RBC <4x106/mL <4x106/mL <4x106/mL <4x106/mL

CADtime 4–16hrs 6–16hrs 16–24hrs 6–16hrs

Maximumstorageperiod 7days 7days 5days 7days

IntegratedStorageContainers 1

1

1

2

c. Plateletadditivesolutions(PAS)currentlyapprovedforusewithINTERCEPT:InterSolandSSP+.

Table 3: Processing Range Requirements for Plasma

Plasma Set

Plasmainputvolume 385–650mL

RBC <4x106/mL

AverageCADflowtime ~10min

Transfusionunits/treatment 2or3(useroption)

Transfusionunitvolume ~200–300mL

Typeofcollection ApheresisorWholeBloodb

IntegratedStorageContainers 3

b. Useofwholebloodplasmatypicallyrequirespoolingoftwoorthreeindividualplasmaunitstomeetplasmainputvolumerangefortreatment.

INTERCEPT Blood System Process SpecificationsEasily integrates into current blood center practices

Right Flap (Inside)

1. Osselaer JC, Doyen C et al. Blood 2005; 106(11):129a; 2. Isola H, Kienz D et al. Vox Sang 2007; 93(Suppl 1):165; Rentas F et al. Transfusion 2004; 44:104A; Rentas F et al. Transfusion 2003; 43:84A; 3. Witt V et al. Vox Sang 2006; 91(Suppl 3):178; 4. Sawyer L, et al. Transfusion 2006; 46:115A; 5. Sampson-Johannes A, et al. Transfusion 2003; 43:83A; 6. Lam S et al. Transfusion 2007; 47:131A; 7. Rentas F et al. Transfusion 2004; 44:104A.

INTERCEPT Regulatory Approvals

CE mark, Class III2002(platelets),2006(plasma)

France (Afssaps)2003(platelets),2007(plasma)

Germany (PEI)2007(platelets)*

Switzerland (Swissmedic)2009(platelets)

*First blood center marketing authorization approved by PEI for INTERCEPT platelets in 2007.

www.INTERCEPTBloodSystem.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 inactivate all pathogens. Not approved for sale in the U.S.

Global HeadquartersCerus Corporation 2550 Stanwell DriveConcord, CA 94520, USA+1 925 288 6000

e-mail: customer_services@cerus.com | www.INTERCEPTBloodSystem.com | www.cerus.com

European HeadquartersCerus Europe BVStationsstraat 79-D3811 MH Amersfoort, Netherlands+31 33 496 0600

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