2395 20 3 2008 5 16 SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. 1
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CONTENTS. 20 3 CFO. 2008 CEO... Translational Translational 3
. 20 3 CFO 4
20 3 P/L 19 3 20 3 17,289 19,500 19,647 +2,358 +147 1,125 1,453 1,585 +460 +132 1,029 1,300 1,049 +20 251 543 850 599 +56 251 5
20 3 P/L 17,289 19,647 +13.6% +2,358 10,590 11,958 +12.9% +1,368 6,699 7,688 +14.8% +989 6.0% 5.3% - 0.6% 5,573 6,103 +9.5% +530 1,125 1,585 +40.9% +460 1,029 1,049 +1.9% +20 975 856 12.2% 119 543 599 +10.3% +56 38.7% 39.1% - +0.4% 32.2% 31.1% - 1.2% 6.5% 8.1% - +1.6% 1 2 3 4 + + + + + 118 100 / 6
15 3 4,494 3,040 3,036 10,570 16 3 5,001 3,571 4,964 13,536 17 3 5,133 4,264 5,258 14,655 18 3 6,255 5,941 3,535 15,791 19 3 6,559 6,514 5,492 18,748 20 3 7,590 8,965 5,338 22,419 0 5,000 10,000 15,000 20,000 25,000 7
P/L 19,647 21,000 107% 24,000 122% 28,000 143% 1,586 1,600 101% 1,800 113% 3,200 202% 1,049 1,460 139% 1,700 162% 3,000 286% 599 300 50% 500 83% 1,250 209% 8
1 P/L 3 19,647 28,000 +42.5% +8,353 100 11,958 16,512 +38.1% +4,554 7,688 11,488 +49.4% +3,800 6,103 8,288 +35.8% +2,185 1,585 3,200 +101.9% +1,615 1,049 3,000 +186.0% +1,951 856 2,950 +244.6% +2,094 599 1,250 +108.7% +651 39.1% 41.0% - +1.9% 31.1% 29.6% - 1.5% 8.1% 11.4% - +3.4% 5.3% 10.7% - +5.4% 2 3 4 + + + + + + 9
1,586 1,600 101% 1,800 113% 3,200 202% 357 538 673 1,054 9 37 102 111 3 25 125 135 369 600 163% 900 244% 1,300 352% 1,955 2,200 113% 2,700 138% 4,500 230% 10
. 2008 CEO 11
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<> / / / SPF/ / / 27,111 89,624 7,916 26,167 13
<> 1 3 ( 7,810.3 ) 2008 62009 2 15 1 1(30 ), (3 ) 2(09 ) 3 ( 1 ) 14
...,. < > 2 ( 4,320 ; ) 2008 122009 7 9 1(10 ) 2(2010 15
12,986 6,203 1. 2. 34 $2.5M 3 4 API5000 16
.. Translational 17
+US) Seeds CRO +US) 18
Combination Product + 19
2008 2009 2010 2011 2012 2013 2014 FDA P1 P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA 20
10 mcg/kg TRG 0.5 mg TRG 1.0 mg TRG 2.0 mg 1 1 1 21
: ( ) 22
2008 2009 2010 2011 2012 2013 2014 FDA P1 P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA 23
Global Industry Analysis, Inc. Intranasal Drug Delivery: A US Market Report June 2007. 24
/ PTH1-34 Peptide YY3-36 Gn RH IL-10 / / / / / / / B12 25
, 2005, 2005 60% 40% 3,000 458 Medical Letter, ML, Medlet Japan KK. 26
3 2,600 (2006), 2005, 2005 82% 51% 3,100 2,600 20070228Market research of migraine 2006, Spectrum 27
, 2005, 2005 18% 5% 7% 5 9,200 Investor update 2007, ORx Pharma. 28
2 4,600 (2006) 3(2007 ) / / 10 % 20 %, 2005 42%, 8500 19 th IDF MeetingMedical Letter, ML, Medlet Japan KK. 2 29
.. Translational 30
Combination Product + 31
(GRAS) 13264 Phase A B C 32
Fit-lizer 1 2 3 33
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: 1000 (ng/ml) 100 10 : 30 : 70 % (1.00 mg/kg, n=4) (0.99 mg/kg, n=4) SD 1 0 2 4 6 8 hour 36
: 1 100.0 (ng/ml) 10.0 1.0 TRG 2.0 mg TRG 1.0 mg TRG 0.5 mg 0.1 8 0 1 2 4 6 8 12 24 (hour) 30 37
: 2 -AUC 40 300 (ng/ml) 30 20 10 AUC (ng h /ml) 200 100 0 S.D. (N=8) 0.5 1.0 2.0 (mg) 0 S.D. (N=8) 0.5 1.0 2.0 (mg) 38
: 3 100 (10 mcg/kg) 100 TRG 1.0 mg (ng/ml) 10 10 : 20 : 100 % 1 S.D. (N=8) 0 1 2 4 6 8 12 24 1 S.D. (N=8) 0 1 2 4 6 8 12 24 (hour) (hour) 39
: 4 TRG 40
A B C 1000 100 10 1 0 2 4 6 8 A PK Output 100 10 1 0 2 4 6 12 24 41
42
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10000 (ng/ml) 1000 100 10 42 % 1 0 2 4 6 8 (hour) 13 % 44
: : : 45
IgA 46
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http://www.snbl.com/ 48