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BioPharma News Digest Antibody Therapeutics

About the Author: 1968

2007 6331/3 FDA201 200 2001 35% 200017200129 20041032006113 20071382010300 Genentech RutuxanAvastin HerceptinXolairLucentisRapitvaGenentech 2

12 MediBiotech Co. Inc CEO, Journal of Clinical Oncology, Cancer Research Gene Therapy, International Journal of Oncology, Cancer Gene Therapy, Cancer Immunology & Immunotherapy, Journal of molecular MedicineTransplantationCancer Biotherapy & Radiopharmaceuticals 40 131I 131I 15 1

1 FDA

/() MuromomabCD3(anti-CD3) Abciximab (AntiGPIIb/IIIa) Edrecolomab Rituximab (AntiCD20) Daclizumab (AntiCD25)

Orthoclone OKT3 ReoPro Panorex Rituxan Mabthera Zenapax

Ortho Biotech J&J Centocor Centocor Roche/IDEC/ Genentech Hoffman-La Roche

1986.6 1994.12 1995.1 1997.11 1997.12

CD20 B nonHodgkin's

34

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

Antibody Therapeutics

Basiliximab (AntiCD25) Palivizumab (Anti-F protein of RSV) Infliximab (AntiTNF) Trastuzumab (AntiHER-2) Etanercept (AntiTNF) Gemtuzumab ozogamicin (AntiCD33) Alemtuzumab (AntiCD52) Ibritumomab tiuxetan (Anti-CD20) Adalimumab (AntiTNF) Alefacept I-131 Tositumomab (Anti-CD20) Omalizumab (AntiIgE) Efalizumab (AntiCD11a) Cetuximab (AntiEGFR) Bevacizumab (AntiVEGF) Natalizumab (-4-integrin) Ranibizumab (AntiVEGF) Panitumumab (AntiEGFR) Eculizumab

Simulect Synagis Remicade Herceptin Enbrel Mylotarg Campath Zevalin Humira AMEVIVE Bexxar Xolair Raptiva Erbitux Avastin

Novartis Medlmmune Centocor/ScheringPlough Roche/Genentech Immunex/ Wyeth Wyeth/AHP Millennium/ILEX Pharmaceuticals Biogen IDEC Abbot Laboratories / CAT Biogen IDEC Corixa Corp.and GlaxoSmithKline Genentech/Tanox/ Novartis Xoma/Genentech Imclone/BMS Genentech Biogen Idec/Elan Pharmaceuticals

1998.5 1998.6 1998.8 1998.9 1998.11 2000.5 2001.5 2002.2 2002.12 2003.1 2003.6 2003.6 2003.1 2004.2 2004.2 2004.11 SUSPEND-ED 2005.2 2006.6 2006.9 2007.3

Crohn's

CD33 B

B non-Hodgkin's

Non-Hodgkin's

TYSABRI

Lucentis Vectibix Soliris

Genentech Amgen Alexion

neovascular (wet) age-related macular degeneration

PHN

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

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BioPharma News Digest Antibody Therapeutics

22004-2006

Rituxan Avastin Herceptin Xolair Erbitux Remicade

B

Genentech/Roche Genentech/Roche Genentech/Roche Genentech/Tanox/ Novartis ImClone/BMS Centocor

1997 2004 1998 2003 2004 1998

2004 1,711 555 483.2 188.5 320.8 1,816

2005 1,831 1,133 764 327.6 674.7 2,065

2006 2,765 1,691 1330 428 1100 3,104

15% 76% 81% 70% 58% 24%

Synagis Humira

Med Immune CAT/Abbott

1998 2002

942.3 852

1,063 1,400

1,167 2,044

13% 65%

2080 2003" " 200474320049 234

20 SFDA11 356 3 I2010 50

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Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

Antibody Therapeutics

3 SFDA

OKT3

IL-8 [131I] [131I] II -

Ortho Biotech (Roche) (Roche) (Novartis)

1999 2001-6

CD-3 IL-8

2005

B

Fc

2006-10 2003-6

CD147

2005

Muromonab-CD3 Rituximab Trastuzumab Basiliximab Daclizumab Cetuximab Infliximab

CD-3 CD-20 HER-2 CD-25 CD-25 EGFR TNF- 2009-626

Roche Imclone System Centocor

Abbott

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

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BioPharma News Digest Antibody Therapeutics

4 JJXSL

J0401761 JXSL0500002 J0402298 JXSL0500008 J0402107 J0402491 J0301094 J0400119 J0402200 J0400652 JXSL0500001 JXSL0600043 JXSL0700004 JXSL0800002 JXSL0800003 JXSL0700050 JXSL0700041

Tac Tocilizumab CD11a CL184 12 (CNTO1275) CNTO95

AVASTIN AVASTIN RITUXAN HERCEPTIN REMICADE ERBITUX SIMULECT ZENAPAX Actemra RAPTIVA ENBREL

Genentech

NHL

Castleman

Genentech

Genentech

XOLAIR

Crucell Holland B.V.

Ustekinumab

38

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

Antibody Therapeutics

5

5

X0404230 CXSL0500018 X0405388 X0302917 X0301010 CXSL0500014 CXSL0500056 CXSL0500039

CD25 CD11a [131I] HER2 CD20 CTLA4 LFA3- CD52

B

CXSL0500087 CD25 CXSL0600007 TNF X0404139 X0400427 X0400429 X0406938 CXSL0500025 CXSL0500026 CXSL0500045 CXSL0500106

Fc II- [131I] CD22 CD22 II EGFR

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

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BioPharma News Digest Antibody Therapeutics

CXSL0600008 CXSL0700011 CXSS0600036 CXSS0800002 CXSL0700013 CXSL0600049

CD3 -Fc II Fc

1. CD20, TNF, VEGF, Her2EGFR, 10 AVASTIN 2. 3. 4. 1000 GMP cGMP CMO 5. GMP

2006 15 ""

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New Generation Flu Antiviral Resistance Test Fast, accurate, cost-effective, and easy-to-use!

QFlu® Neuraminidase Inhibitor (NI) Assay Real-time assay more sensitive than leading assays currently available on the market.

Suitable for high throughput drug candidate screening, drug resistance monitoring, and evaluation of flu vaccine candidates. Advantages: · · · · · One-step assay Operation takes about 10 minutes Results available in 10 to 30 minutes No virus titer determination for determination of IC50 Custom-designed formulations available

Cellex is a medical device company dedicated to innovating and developing new generation diagnostic tests. Cellex currently develops, manufactures, and markets 2 versions of NI assay (one is specific for influenza neuraminidase and the other one is not specific for influenza neuraminidase). Designed for influenza and drug resistance detection, as well as for high-throughput drug candidate screening, the assay is cost-effective and easy-to-use. The convenience offered by the assay helps our customers significantly cut their labor costs. Our tests are currently for research use only. At Cellex, our mission is to make a positive contribution to the world by advancing diagnostic technologies and developing innovative diagnostic tests; our direction is driven by the need of those whom we serve, including researchers, physicians, and patients.

Tel: 301-947-0202 Fax: 240-387-6100 E-mail: [email protected] Online order: www.cellex.us

Tr e n d s i n B i o / P h a r m a c e u t i c a l I n d u s t r y

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