|
99.1
|
News Release: Kamada Reports Encouraging Discussions with European Co-Rapporteurs Regarding European Filing for Inhaled Alpha-1 Antitrypsin to Treat AATD and expects to report results from its Anti-Rabies Immunoglobulin U.S. Phase II/III clinical trial in the first half of 2015.
|
Date: January 7, 2015
|
KAMADA LTD.
|
By: /s/ Gil Efron
|
|
Gil Efron
Chief Financial Officer
|
EXHIBIT NO.
|
DESCRIPTION
|
99.1
|
News Release: Kamada Reports Encouraging Discussions with European Co-Rapporteurs Regarding European Filing for Inhaled Alpha-1 Antitrypsin to Treat AATD and expects to report results from its Anti-Rabies Immunoglobulin U.S. Phase II/III clinical trial in the first half of 2015.
|
News Release
|
![]() |
|
·
|
Kamada has held encouraging pre-submission meetings with its European rapporteur and co-rapporteur with regard to the Company’s Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its inhaled alpha-1 antitrypsin (AAT) for the treatment of alpha-1 antitrypsin deficiency (AATD). The co-rapporteurs advised that they would consider the entire study data once submitted, including post hoc analysis and will not reject the application simply because the primary endpoint of the study was not met. They agreed that the application fulfills the requirements relating to unmet medical need and benefit to public health and that it may meet the scope of Conditional Approval (CA) if the company convincingly proves the positive benefit-risk balance of the product, by the time of MAA filing. The co-rapporteurs have requested the addition of supplemental data analyses that may address the benefit-risk balance and support the already available safety and efficacy data. Kamada has begun conducting the additional data analyses and plans to file the MAA with the EMA in Q4 2015. In addition, the Company expects to present the complete data set from the Phase II/III clinical study at the upcoming American Thoracic Society Annual Meeting in May 2015.
|
|
·
|
Kamada expects to report results from its anti-rabies immunoglobulin U.S. Phase II/III clinical trial as a post-exposure prophylaxis for rabies in the first half of 2015 and maintains plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in 2015. Kamada has a strategic agreement with Kedrion S.p.A for the clinical development and marketing of the product in the U.S.
|
Contacts:
Gil Efron
CFO
ir@kamada.com
|
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
|
@#*2 M?H`U_^,4?\)#K'_/Y_Y+VO_P`8 MK%HH`VO^$AUC_G\_\E[7_P",4?\`"0ZQ_P`_G_DO:_\`QBL(2Q,[QK+$TL>/ M,B26-I8MWW?-B5B\>[^'>J[NV:?0%S:_X2'6/^?S_P`E[7_XQ1_PD.L?\_G_ M`)+VO_QBL6B@#VBBBB@#S'Q#_P`AB\_[=_\`TE@K%K:\0_\`(8O/^W?_`-)8 M*\*^/'Q1L/@K\'?B'\4M2>)(?!WAO4-3@$QQ%+J*0.-.MWR0-L]WY<1YS\W` M-=&$PM?'8O#8+"TW5Q.,Q%'"X>G'>I7Q%2-*E!> IS8S%X?`83%8[%U M%1PN"P];%8FK+:G0P].56M4?E"G"4OD?DG_P59_X*+7GP1A?]GCX-ZG#%\2] M>M,>-/$=NZRW/@S2+A`PL;,*2L&LWR,H,K_O;6$Y5/WF:_G-T"_OM4NI=2U. M\N=0U&^F-S>7UY,]Q=74\CAGEFFD+/([,2 (/%^MWFMZA<7$C2R*][.TT=L'8DF*TB9+:$'I'$HKT_PC_JXO^`_^ MA+7^H/`OA[E?AUPOA )_&&@?&SP';^$Y]?E-_KMH;[1-!N?(EUF&W1W M,,B,5BD$*-<\/Z):^(/B%K>K0:7-<6NH>)-2B-[=0:22DD1S?7;8 5&EF6%RJ&&RQ9]PWDU&M_:6 M,PF.C@:6(QE''UL0XT7[2A@W&%-RKMR^:_'WP?\`B1\,/LK>./"]]HL5[_QZ MW3[+BRF;KL2\MS);F3'.SS-Y'.*Y+PUXGU[PAK%EK_AS4[K2=5L)DFM[JUE: M-@R'.V100LL; AYK[YA^,NH?'KP+\:=&U73+>Q\$^$_"%M=^#M"8_ M:9]*DL9-MO=R7KCS'O)0H:=QMW *_.=3E5/J`?TKV^',QS+-\+C\#Q'@,' M0S'!U*6'QV'H/VV$JTL9A*6*I*5.K*JHU/95O9XFC[2O252,N2M4@[K\YXPR MC)\@Q^59EPAFF8XK*,QI5L7EF+QK_%KX=V'Q-\'7N@:AKWBKPX(1-?VFJ>#];ET+58+R&W MD$#/=11RF:V1CN>U==DI&"1UK\(/V?/B9?\`PL^*?ACQ!;3F*PN-0MM+UQ,D M)+I-_*MO=;QT8Q)(9(\]'`(P:_H:N)X[K1Y[F%@T5SILD\3#D&.:U,B'(XY5 MATK^7/$GA5\#\583&9.Y8;`X^?UW+7#5X/$4JD5B,/#F37)2E.$Z2ES?NJJ@ M[J.O]Q^#'':\3.!\;E_$"CB\URF*RS..?W5F&$JTG+!XVHHN+]I6C3J4\1*/ M+>O0E433G9?@S_P3ITCQM\;OC'\:K#XB_&/XK:QI7P;U*T_L+3H/%4UE!J<[ M:]J&F1OJVR!S (?$GQ(\<^$O@3^S_`.+?'&C_ M`!P5[6?4]>\):Y-9>&_`?AMY%N;_`%#Q?!';SVMS>W.GB5;."ZEB?,D)16DP M*_';X$?M0:S^S+K'[7&H^'-&O;O7?&GB>TT"RU]+8SZ7X43_`(2W6C=:MJ`4 MJ7G2&1FT^VW)]HG1E\Q-N:_?S]C#PO\`##3_`(2V'C3X?^*'^(&J^/BVO>,_ M'VH*HUW6O$%TWFW]I?QEYI["'3[@M;6VFO-(EO%$BJS@!J_4O%+!XKA;B>KQ MSBL#"IEU"AE>7<)9;2P=%95/,JV09?B,QQ6:0HT?JT<%3Q%:M4>`K\M?-J_- M3TP=&M)_D'@MC\%QGP;0\.,%F,Z.;8FOG&;<<9O7Q^(>=T\HH<39GA,KP>2U M,1B'BYYC5PV'P])9GAG+#Y'A5&JW+'U\/!=M\"_@5J'PFL!=^)OBC\0_BAXP MO;&WM=8UGQ?KS7NGEH0S8TO25@B@L0))),R*S/*NW=C&*YG]M/QUJ_@7]GKQ MG)X8N[FU\8^*!9^#O"/V"01ZC)K?B"4VT'V'JWG(BR' MCBL]JK"5LPGBL36GB*M;!82>+S2M6JU9U9_59RE)R=SP+_@DI\:-8\8_#+QK M\*O&.I7=YXN^'GB:]N#_`&I)++JD]GJDAEN1*\[-*R65TKPG=@*3QP0*_6B_ MLX]1LKJPEDGABO();>26UE,%S&DJE&>"903%*H.4<`E6P<5^`.D:SIG[*/\` MP4YN3I6KZ;=?#WXUW%M]LETR\MKFR@_X2SYH;&'[--)$DMIJYMXV9R&Q(V!W M/]!/3T/N.1^!%?2>,66T*'%&$XGRVC]7ROC7*L!Q/@H1AR1P^)Q5*"S'"J/+ M%1J8?&PG.<++E]M&Z2:1\EX!9MB<1P9C>#LXQ'UK.O#S.\RX-S& &?$/B*375337NH(=6T^\DDA1C%=++)]F\P*8P5$><`G^@KP3XM MTGQYX0\-^,]"N8KO2/$VCV>KV-Q"P>-X[J(,ZJRY!\J820MCHR$5^7_[1?P, MTC]HWXR_M.>"/LW_`!4^F?!/PS<^';HHK,NKV-[I>LV5O"Q&8EO7@%I<2`Y\ MJ1Q@C@\A_P`$E_CI?W_AOQ?^SCXTNFC\3?#;4+J?P_;73'SY-),S0ZA8QAR" ML.FW468D4$D7#-@9K[#C+*\-Q7X:Y/GN%I0_UFX*R[)UQ+R4*-*OF&3Y_A*. M+P>:550A#VSPV(J.C.M/FFX>UJU&DTE\%P!G&-X'\7L^X:QU:K_J?XAYMG[X M/53$XBMALJS[AC'5L%CLFH/$U)JA'&86'UBEAZ?)#VGU>C2B_M?K5X\\8Z5\ M/_!GB;QKKDZ6^E^&M(O-5NI'*@8MXR8XQN(#-)*40+G)R<9-?S^?L=>/?B3^ MUM^UGXZMOB)\2?B1HGA:/^W/%%MX0\/>(9]#M[-5OBFG:6"D#RP6MLC1.8=N M74>6QPU?I_\`M/W=W\8?B;\,?V7-"ED;3=7OX_'GQ;F@)"67@S0I$;3M-GD3 M.V36M0:2+R9,!D@S@]OA[]DZQT7PW_P4Y_:$T?38H-.M&B\10V-I&-B.Z7<3 M%8HU^53Y<9 7XF5*E5JY3E6'S& MA@4I*K" M/<+P[FF%A7K4:.>9WBLJK9EBZ59T:E..(PF4T(X'"2HU'.$\;C,71G!SP[B? MN7:VZV=K;6D;RR):P16Z23R&6>188UC5YI3@R2L%!D<@%VRQ&37XF_\`!6GX MG>/].F\$^&/A_JFO6>G^"18>/_'SZ+ EZ$FK#;6U%U,$;NJE MCE@PXK]M9IX+6&:ZN7$5M;127%S*>D<$*&2:0^R1JS'Z5^6_@'2O!?[1WA'] MK'QEXGU_P]N^+6I:OX+\'?VEJ^F6_P!G\.>#WN(-(N8H)[D2IYNH6<-[&VT# M>P9 W6 MUO+:4\D3+)#OD#?,#)S6+^TE\/+;QW\-M;N#XG\8^%-2\,:1K.K:/J7@_7IM M$F%Z+,,O]H+''(M_;IY"E()-JJ6 15^!_$K%9;A)NG2P^<4,5E=9)253*\QJ0QDE-2C.#PE=4)J2E&3C4 MC*^IT<#\2X?Q'\(L#F^/IQK5L7D&(P6=8>3E&5/. /; MK1X[6"YL+B AS7TM\6_A7^V)^SUIU[\2_@E\:_$7 MQBT304?4]<^'/Q'MK;6-0GTNU#37:Z7J$:PS2O\`9U=FRF^,)O1217C_`/P1 M4_Y)E\^R@:-_Z:[ROVLVH_R2()(Y`8Y(V&5DC<;9(V!X*R(61E/!4D'@U] MIXG<5XSAWQ2XGP-/!Y5F&187'8.F\@S#*\!B,NGA9Y;@:M;#T8RH>UP7M95* MDE6P=6A5A4G[12OO^>>#7!6`XL\%^#LQK8_.\LXDQF7XZK'B;*\YS+"YM#&P MS;,:6'Q5><<5[',/8PITH.ACZ.(HSHP5)P4=5\A?L@?M<^$_VK?!-WJMA9CP M]XT\.2QVGB[PE-.))["=E^6\M@^)WL)I`T:22(,2*8\[@0/J7Q%K=GX:\/ZY MXBU%Q'8:#I&HZQ>.2`%MM.M);J8Y/'W(CC^O2OY__P!G-9_@[_P5.\>^!/#C M"+P_XGE\1#4K"W.R!X[E%U2T38@VA+*>XD,<>,+G`V]OU%_;@\>#1/AQH7PV MLKNWMM<^,OB_0O`T$DUW':"UT6>^BN_$5[+)(RJ+?^QK2^MV)=5+2A2W->'Q MGP'E^$X[R++ 'WB;FF.\->),WXG=&MQ)P1FN><+9E7I4X4:.;YOE56&&RZM M2HPM"G4S2KB<'1G2@E!8J=3E48-)?F1^PQ\?_'ME^VMXW\/_`!,UC7;JT^-) MNYO#*ZS<32*]O'>7 -K#XC_``_\'^.],P++Q7X?TS6H$#!C$+ZUCF,+E>/,C+;7'9N* M[/%S#X3.,#PAQ_E6`CE^`SW+9Y+C,)3IJE'"9GP]/ZG&$H*$.7V^`6'G3]U< MT:3EHG$X/`K%X[(,QX[\+\ZS.6:YEPUFU/B'`8^I5]M+'9-Q33CCYU(U'.HY M?5LSEBH55SRY9UU&]U([BBBBOQ$_HL]HHHHH`\Q\0_\`(8O/^W?_`-)8*_'W M_@M)XINO#W[%.M:9;O,D?C#Q7I6@W8B8*K01QR7X6;D%H_,@7A>)?V*]9U*T5VC\'>*]*U^]"(6)MI(Y+#G&< M`/,I)P?PK]`\*?J__$2>"/K7+['_`%CRV_-\/M/;+ZO\_K'LK>=C\Z\7'B/^ M(8<=_5>;VW^K696Y/B]G[%^W^7L/: >`DC#V>KZ]8R:T6SMAT"RGBNM:N M&(!`$&GQS2$G"C;RP'-?ZA\08RAE^78O'XF7)A\%A:V*KS?V:6'C[6H_7EB[ M>9_E/PS@L1F698?+\)#VF*QU>AA,/#7WJV(JPI4UZ. );R7Q';>.IO!T<0(N_$.IV=Q'X<7Q2B_.NDV,,-W)%'=_ MZ,YG)"EPF*E[XB^&'C/]G/X.>)OBS!KFDPZ[XY\<:CI5GX/B@^S6,UU=7\TU ML\<@!%I;P.(K<1@,`@KS_P"&/Q (EF]*&<5\=A\^S'BO"YO*M0Q4Z4\- MEF>9UCZ&'P=.2E3HSPN+IXO`XJIR3J5?JM-2DH ,S?A_BOAS+L1B5BX5<1#&8*M@\QP=)U*=.A];J M )=,@DN= M+D!)`#2/''`!U8M@9Z5\V7MG<:=>7>GW:E+JQN9[.X4@C;/;2-#*,'GAT:ON M.',/'++JRKXO%X+&X:G2H2K5I6E4>&K83$X."24:= M*C2BDKL_&.,,7/. 3D[)*NK;&5^GELLF?38P;^E?T=_"35Y-?\`@KX+UF1S M*]_X,BF9R&!.R">')#?-QY6,GTSTK^<15WLD>,^8ZQ@>I=@H_G7]`>C?#3Q# MKOP!\`^!M&\8:K\/[RW\/64-[J>E013WK6DT$QELU$Y"Q[_/#B3!8''&*_,O M':&$J8+A:GB,13PDI9MB$\34A4J1HX;ZO%UJCIT83K3BI^QO&G%MMQO;1G[9 M]%NICJ.9\;U<+A*N-A#(,(_JE*I2I3KXOZZUA:<:N(G3P].4J;Q5I5:D4HJ5 MGNG^1/\`P3>^&GA'XN^,_P!N?P#XWTFWU?0->NK.WN()T#/!,/%VO?9[VUEQ MOM[NUD/F0SQ,LBG<`VUF!Y;0-9^*G_!*_P"//_".>(VU'Q/^SSX\OGELY86D MN+-+&>;8MW$K%DLM M,[6^UV5'\36MS;6D]GXBC6X>Z,>H)E69O.DDD1U=2KNQ(.:^M?CC\"_`7[0/ M@#4_A_\`$#3A>6%]!_HE_"$34=*OT`:"_L9V1S$\ J<8YK"I6GQ)X><68'*<'GF4U,+B,-B'?!;BJCP%D=2CAX<(^*O`^8YUCN',\I8W!XO!9GA M '/VA?B?IG@;7TDBU'P]%):M9O',,3)$74R0+ M,H"R+$ZJP`^4 YB971$D8R!&5LL3R!7P/UOASAG*N)/]4N,L3/-78^KFN&J9IDN;Y>^)\7'#82ACHX.=7GK9=@L`\R=!SI2Q=.MC8J-%NBY MS_-3_@I%^R'\/OA+\(]`^,/P5\+Q^%M9\">)M/O-7NK.2XE"V?VB-[*[8S/( M%D@U#R-C'```X[U^J_[+OQ6M?C7\!_AU\0;:02SZKH-K;ZF`V^6/5+"-;6\$ MZ\M'-))&9MCX;;(I`P03F?M(?L_2_M%>%3X'OO'>L^$_"E];-;Z_I>DVUO,- M<`N4N8#/+/DQ"!HU"A%R>NX&O#/A)^PWJ_P/\/:AX4^'7Q_^(&B^'[\S2C3! M#92V]E>S*B-?68D4F*?:@'4IT.S(S7=C>),FXJ\.LHRCB/B:I_K7DV=X[%8+ M%XW"YICF\FQ\*4:^"Q6,C1K3E5CB*:Q%#D]K"-**IWC)RMYV7<)9_P`%>*^> MY[PGPA37`_$'#F78/,L#EV-R;+8_V_EDZDL-F.!R^>(H0C1EAJKPF)YXT:DZ MSG549PA&4MWX57\&J?MQ_M*M;W%I,FE^!_`VEO%',LD[RFUTN6X+Q`G$<,FZ M"0]`XVMS7Y??MA^'M6_8=_;-\'?M)>"[61/"'CB__MG4M/MLI;37$#1V_B72 MIHT_<)'<0&.>SAD"K).&D52P)'Z,?#O]@NZ^&7Q$UGXH^'?CQX^?Q=XE)7Q- M?:A%:W0UV%YUN'BO8\QJ0)%#1F/9Y9`Q\HQ7T'^T?^S;X1_:7^'VF^!/&<\D M0TO5M+UBTU>*%);I+BQ>(W2;69<1ZA$LL4JA@%\W=AMH%>ID_&?#7#7&.`K0 MS-YYPCFG"V7\)\4898#&8:I/!8?*,-@*]7V%>FO:6Q=%8JA*E*554G4IN-.< MD>-G_A_Q?Q?P#F>'J9-'AOCO)N-,RXXX,QCS/+\92IYAB<\Q.9X:@L3AZDO9 M7P.(>"Q4:\(4?;QIU%*K"#OYE^QAH6K^)=*\9_M&^,;1X?%OQSUH:KIEO 68*"2!D@`GI7[.^(/`5U-\/[3P)X'\1WO@$:;:Z9IVEZQI<$5Q=V& MG:;%Y"VT4 M:K<^)2EFUW=7E^)%O'G4KY;I<1RR1R)M`V,=NTX- Q'#N28"&`QN*6!P].6&CEL:LJ%.5.GA,-A<-1PON3J5KPE4=-[R[.+^!^ M*H+PHP>0Y)//%P7Q1A.+.(LSJ9GEN"EF>,JK$2SB=&GB:T*M3'8O&XK$8U.I M"EA[5(TU525H?1O[:_Q.NOAC\`O$TND3O#XI\:2VO@/PH(@3.VL>)'^PHZ(` M79(HI',C*,)E2W%<#\/?^">_[.FA>!_"6D^)_AY8ZKXDL-`TNWU_49;N\$E_ MK$=I$NH73B.<1YGN1)(=HV_-Q6=\5_V'-7^-%YX>N_'GQ]\>7Z^%;R'4="L[ M>VL[:SLM1A>.1-0\E2WF7>^)"9'8C"@*J\Y^ROA]X8U_PEH,>D^(_&.H>.+^ M.3/]M:G;Q6UW)'C&R18249NA+@+DY.!FOFZN=X?A_A/+LOX6XKKPS2MF6,Q^ M??V;3S7+:F(YJ>'P^64H8F5.@JV'P5&.*J3A4E&U?%3=.$K.1]=A^'L5Q3QO MFN:\:<$8:>34,HR_+.&?[6K9)F]+"\E:OBLYKU<'"OB98?%9AB)X.G3J4HU+ MX;`P56<':"_"#XC>'=%_8*_X*$_#CQ+X4L7T7X6?$.#2[.:QC:5[9TUMO[+U M*TW$LXMK'4KBVN&).$$;,QV@FOW5^*$D<_PP\:SP.LL,WA+5IHI4(:.2*73Y M721&'#(RD%6!P1S7QS^T9^P+I'[37BZW\3^/OBCXI6'1Y[MO"^D6-M;16_AZ MUNI$E:VMI 4\1BJ%%SHXER2]K5G'DG*G#F7RW!?#/&'!6 M8>*&58+A-_ZFY_F>+SGA#"X7-,FI3P6+QV$CALQPCPSQ4*>%P.(KQIXC!QC) M^QHTYJI3C5GR'PG_`,$5&4_#3XX1AE\S_A/M'?9D;]@TV[4OM^]M#$+NQC)` MSDU^N'Q-^*'@SX.^#M:\>^.]9L]%T/0;.:\E>ZF2.:[EA0O#8VW^TH]-%C]GO]ARGVF& M6.17*GD%=K=MVTD'V"+]AOX?>(M1L=9^,GC+XA_&N^L)!+#8^-->C/AO>LGF M(QT.QL[9&V$)LWW#$;>3VK/CS&\!\4<=9OQ5+B7%U 38N.;R MC1P>&PU7#4YXQT,!2=1X=\N(G7G[-5%)T)N#@]/#'+?$O@SPUR+@J'".!HY] ME&$QF%IYMF&?X&>10GB,=B<72Q56E@%B GPK\5_&']H[XD?ME>*=)O-.\,ZA?:U;>`SJ43Q3ZD=3F96>&&7YY;>RL M%@1+I5\L2[HU?=D5]0>+_!7A']K']K_7?"OB^QC\1_#CX`^$!975DL[K:S^. MM>>"66WNC`ZDS6$#7*?.=RD;5XS7W9XA\#?:?`\O@KP1JC?#R-((K73;[0+2 M!6TJWC!5H[2W.V-2Z$#> +-=\6^%/C?XSNKSQ=J\& MK^,8-7M;6]C\17,4PDDDNFW(Z32INA$BG"*Q^1L"M<3QW@<]S+B#BBIFD>', MTH9#1X;X*RVE0S"N\KR^G[##NH\?AJ,E3Q']G/&485H6E+%8NI4<:-.,6983 MPUS'AK*.%^#:.33XMR;$\35N+?$/.,1B "Z8F\?0[UFVLR-^\2&RN%2TC1P`F=J@"OTO^('AC6/%_AB^T'0_%-]X.O;T M>6=;T^"*XNHH&1DFBCCF(0>:C%2QSCTKX'^%?_!.33_@UXVN_'O@/XV>/-'U MO59-VO&&*S^SZY`UR+J6UOX=NPQ23#?^[V,I/!QQ6&6<79?GGA_Q)PUQGQ)B MJN8U