`
`with Recombinant Human Hyaluronidase (rHuPH20) in Subjects with Hereditary Angioedema (HAE)
`
`LaBarreG, A. Phillips‘, 8. Gelone‘, C. Broom‘
`J. Schranz‘, Fl. Levyz, W. Lumry3, M. Manning", J. Jacobs-i, S S. Dychter‘i‘, M
`‘ViroPharma Incorporated, Exton, PA, 2Family Allergy and Asthma Center, Atlanta, GA, r-AARA Research Center. Dallas, TX, 4Allergy and Immunology Associates, Scottsdale, AZ,
`5Allergy and Asthma Clinical Research. Inc., Walnut Creek, CA. 5Halozyme Therapeutics. San Diego, CA.
`l~
`
`PHARMACOKINETIC RESULTS CONT'D
`Mtn—m—mmmmmw
`
`
`
`u
`
`WNW
`macho-q
`—mwscomII-fl
`—mxn~nmxomflfl) =
`
`I
`I
`.
`I
`50 W I” no
`no ” an m ‘0
`1.0M
`
`...I.
`0
`
`I MMHMLQIHH
`vacuum-an vmammmmuuwm
`- mmmwmmmmhumm
`
`DISCUSSION
`' WWHMMWMIWMDWM
`MSG‘W-Iwm
`I elmmmnwmmbmwwmmmm
`mwmmmMammummmu-m
`0 cmwmmwmcl “WW
`‘ CMMWWWMMOIIMWWWWLMM
`unnwmmm-anxwmww
`t mamammwm-mwmnw
`deimmmbmmm
`0 mwuwummmmwmdmmmm
`cm.c..,mmcmmm1m2mwauuw
`- wmummmmmmhmmm
`mmnflmmwm
`
`QONCLUSJQE
`0 Wwdmmlflmmmhm-flflw
`O mmmmmmWM-flmm MW
`«macaw
`0 mmmdmmmmmflum
`mun-mama“
`
`(no
`
`i“
`i“U
`
`EFERENCES
`1. m1uw1m.mimw-Im
`2. WW.«¢JWRu—.m:1iwt
`1 mmmoumwm.mmwm
`I. mnau.wm.mmmn
`5. spam PJ.n-.cuwuiu¢;imu1-in
`a mqum-nw. 193mm.
`
`—-mmn-m
`—Im§:ufl
`
`l ‘
`
`‘
`%
`1
`
`somm;nllonutso
`MM
`[ WMNMLtlmfl*7, ,,
`
`VI R013} bug/IA
`
`viiuvrvetnu lrzcrgcmiud All no
`
`PHARMACOKINETIC RE_su_L1§ (comp;
`- nummnmmmmmmfimmmmamm
`M"W"' WWI-1161M
`' Amdmmmm “WWWWNCIWZEMUM
`mammumhmawa
`
`mam—mumcimmwmquO—umwm
`
` Iml‘lfl‘fl)
`
`Imam-ii
`lmxomm
`lmsclll-fl
`mmxomm
`
`mutual
`
`msumummmwmmenu-wm
`mm
`
`Immune.
`manual-41
`lmxomm
`lmscoI-SI
`
`umxomm sauna-«macaw»
`
`nun
`
`I'm
`
`mm
`h~ml
`MMMIMn—Immumdwm
`mthhmmmmwm
`l V
`V as
`
`PnAEMAgommc RESULTS
`. mum-c1 mWW-m-mmmnywcr INN
`mmmumummmmhmawaufigmz
`
`ammwwmmwm‘uumw
`
`W m
`
`44 (18)
`“(16)30a
`N (18)”M
`20 (15)
`23-“
`10:51
`
`
`N (15)
`”(33)
`um)
`u (u)not
`1961
`moo
`as.
`
`
`mmmimummmnmumm-Wma—uad
`Wumwdwunwmmmuw
`
`“LMMMWWWWMMWWW
`«hummus-m
`
`
`0.”
` 0242
`02“
`0.130
`
`(0-110)
`film)"
`III-W (0.09”
`(“my
`m
`0.212
`cm
`0.075
`0.176
`
`0-“)
`WM)‘
`(”WW
`(EM 0”?
`21.6
`12.0
`7.2
`15.0
`m
`(4-!)
`In"
`(23"
`('3)
`(W
` mmmrmmmmmnmummmummmwm
`Minimum
`
`MLMMUWWMfl-mm
`
`l
`.
`‘
`‘
`,
`l
`‘
`l
`
`7 73
`
`u 1
`M
`In
`marlin-Cl
`go,
`—mnuscwu
`in
`i”M —mxomm 1
`u u
`——mscuusn
`Mu—Fr—v—F—v—"f—v—v—w~.fi
`0-!
`I
`l
`I
`m2.mm) .
`0
`so
`In 150
`no
`15°
`in m m IN
`III-um
`
`I WMMDMLI.I.IU11
`
`l
`
`mmmvmnmwmumamm
`
`MEMQLEIGQME
`- mmmmm.mm4mummmwml.t.ui)
`moan-mm
`0 mmmwmmmmmwhmmmmm
`- MMCIMmMmmmmiI-ummmmwmdmam
`0 Wm:
`o Mmlmmmwwwmm—qwmcimm
`mmmmmmwwmu
`o wmmmmmw—mmmm
`fin.“-
`o mum-ammwmnmm manna-wt».
`autumn-momma"...mmmummlcmrmm
`savanna
`
`BESULTS
`M1.Wmmumanmw
`CHIRTLE‘IWWSCO ‘mm551
`_ “mwm‘w I
`"-"°°“'“""“7‘ " H.
`mm lo-lvvll
`‘3
`—Pom-noon.
`U
`m...
`mm» «m
`G
`I
`7
`3
`2
`B
`an.“ m an"
`”1.7
`m1
`m1
`
`
`
`SAFETY AND__TOLERLBILIIY
`0 mmwmmammmmmmnmwwmwm
`mantemmm
`- MMWQMWMHMWMHAEMMNM
`' N001 “(Mmmmoqwuaodmwmwmommw
`M20
`mzmmmmm
`cmRVzE wow so v cmma znoou sc +
`
`— 2omu mm
`
`
`
`lnton Treat_zietyPop no N
`Number of Subiaclx with :1 TEAS
`I
`All TEAEs
`l
`l
`TEAE; relzhd to
`- d
`-
`I
`Total Number 01 YEAEs
`u
`All TEAE!
`'
`ll
`TEAE: mated to sway drug
`I
`I!
`Milo
`a
`I
`Moderate
`II
`2
`2
`Severe
`Wuwmmmnmmmmummnnvimunfin
`0 Iwmmmmulmwmmm
`o IMRMWMWWMMM
`o mmmmmlmfimI‘Mfl-flamfllm
`o ummmwmmbm-mm-mmzmu hold-m
`mmwzmu-m"mmmummmmm
`um
`
`
`
`II
`‘1
`'
`01
`3
`II
`4
`
`: ABSTRACI
`: mmm:mm,mumwwmmnm
`mwmwmwummmc‘ Micah-mm“
`mmmmmwmmmwwmmumuw
`dun-.mpomummamscwuwmmw
`mmmwhmm
`mmwmmmmmawmwmm
`mimumuxmummunmmmmhz
`mmmmwumhmMmMWthflm
`mmmmm.mmmmm
`madammmmmuw. Mutual-Itch”
`mam. wmwmmmmmhmmdm. will-o-
`mmmhzmmmmmmhwam
`mwmmwmumam. Human-immune
`mum-Immumnmauimmqmdwonm-mcr NIH-void
`ulS-Oflg/LMUWIM-Z‘IommmmmmIMMhfllII-M
`”MIMIC“
`Wmm-amxwmmwumw
`thmmm NHmM-flmoth-fl-Mydfl‘l
`Wmmwhw
`
`fiACKGROUND
`- maumm.mmmummmummw
`mmmmw-mdmmmmv
`' munmmmu—nmnmmmmdcim
`WlnmmmmmeMhmmm
`mmwmhnwuwwm,mmm
`I mk-WWWJWIEMWWWWWNID-
`demwmmmmunmm
`o Mmmmmmmmwmvmpmmm
`l wmmumulwwumdm
`1 MWWhmbWNMpWWd-mmdmm
`, WW
`- mmmfimdwmznumemmmmomnm-mm
`dwmmmm
`
`METHOD§
`Hintflfllm
`
`
`
`‘MMMMWMMZM
`
`
`
`
`
`Page 1 of 1
`
`CSL EXHIBIT 1004
`
`Page 1 of 1
`
`CSL EXHIBIT 1004
`
`