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BIOTECHNOLOGY Presented by America’S Biopharmaceutical Research Companies

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2011 REPORT 2011 Medicines in Development BIOTECHNOLOGY presented by america’s biopharmaceutical research companies Biotechnology Research Promises to Bolster the Future of Medicine with More Than 900 Medicines and Vaccines in Development In the human body there are Biotechnology Medicines 12 trillion cells, in Development 200,000 proteins and 25,000 genes 300 298 America’s biopharmaceutical research compa- The biotechnology medicines now in develop- nies are using biotechnology to develop 901 ment make use of these and other state-of- medicines and vaccines targeting more than the-art approaches. For example: 100 diseases. Biotechnology medicines are developed through biological processes using $JHQHWLFDOO\PRGL¿HGYLUXVEDVHG living cells or organisms, rather than the tra- vaccine to treat melanoma. ditional chemical synthesis approach. These $PRQRFORQDODQWLERG\IRUWKHWUHDWPHQW medicines in development are either in human of cancer and asthma. clinical trials or under review by the U.S. Food and Drug Administration. $QDQWLVHQVHPHGLFLQHIRUWKHWUHDWPHQW of cancer. Biotechnology medicines use many different $UHFRPELQDQWIXVLRQSURWHLQWRWUHDW 78 cutting-edge approaches to treat disease. A age-related macular degeneration. 64 monoclonal antibody is a laboratory-made 50 version of the naturally occurring immune These are only a few examples of the new system protein that binds to and neutralizes ways America’s biopharmaceutical research foreign invaders. Interferons are proteins that companies are attacking disease through bio- 23 interfere with the ability of a cell to reproduce. technology. The 901 biotechnology medicines Antisense drugs are medicines that interfere and vaccines in development promise to push with the communication process that tells a the frontiers of science and potentially bring e y cell to produce an unwanted protein. Nano- more and better treatments to patients. technology is now being used in biotechnology vaccines antisens cell therapy as drug-delivery systems, new treatments, and gene therap diagnostics. recombinant proteins monoclonal antibodies Biotechnology Medicines in Development Biotechnology Medicines in Development—by Therapeutic Category Autoimmune Disorders 69 Blood Disorders 32 Cancer/Related Conditions 352 Cardiovascular Disease 59 Diabetes/Related Conditions 24 Digestive Disorders 27 Eye Conditions 20 Genetic Disorders 19 Growth Disorders 5 HIV Infection 39 Infectious Diseases 188 Musculoskeletal Disorders 22 Neurologic Disorders 44 Respiratory Disorders 40 Skin Disorders 28 Transplantation 18 Other Diseases 36 Note: Some medicines are listed in more than one category. Biotechnology Medicines in Development—by Product Category Antisense 23 Cell Therapy 64 Gene Therapy 50 Growth Factors 10 Interferons 20 Monoclonal Antibodies (mAb) 300 Recombinant Hormones/Proteins 78 RNA Interference 13 Vaccines 298 Other 45 2 Medicines in Development Biotechnology 2011 Biotechnology Medicines in Development AUTOIMMUNE DISORDERS Product Name Sponsor Product Indication Development Phase* Category A623 Anthera Pharmaceuticals peptide systemic lupus erythematosus Phase II San Mateo, CA fusion (SLE) (650) 931-8868 protein Actemra® Genentech mAb rheumatoid arthritis Phase III tocilizumab South San Francisco, CA (early-stage disease), (800) 626-3553 ankylosing spondylitis AGS-009 Argos Therapeutics mAb SLE Phase I Durham, NC (919) 287-6300 AMG 108 Amgen mAb rheumatoid arthritis Phase II completed Thousand Oaks, CA (800) 772-6436 AMG 557 Amgen mAb SLE Phase I Thousand Oaks, CA (800) 772-6436 AMG 811 Amgen mAb discoid lupus erythematosus, Phase I Thousand Oaks, CA SLE (800) 772-6436 Ampligen® Hemispherx Biopharma RNA product chronic fatigue syndrome application submitted rintatolimid Philadelphia, PA (215) 988-0080 (Orphan Drug) anti-IL6 Bristol-Myers Squibb mAb rheumatoid arthritis Phase II (BMS-945429) Princeton, NJ (800) 332-2056 Alder Biopharmaceuticals (425) 205-2900 Bothell, WA anti-LT alpha Genentech mAb rheumatoid arthritis Phase II (RG7416) South San Francisco, CA (800) 626-3553 anti-TWEAK Biogen Idec mAb rheumatoid arthritis Phase I completed (BIIB 023) Weston, MA (781) 464-2000 ------------------------------------------------ -------------------------------- lupus nephritis Phase I (781) 464-2000 ARX424 Ambrx interferon multiple sclerosis Phase I (PEGylated interferon La Jolla, CA (858) 875-2400 beta-1a) EMD Serono (800) 298-8088 Rockland, MA Arzerra® GlaxoSmithKline mAb rheumatoid arthritis Phase II ofatumumab Rsch. Triangle Park, NC (intravenous) (888) 825-5249 (see also cancer) ------------------------------------------------ --------------------------------- rheumatoid arthritis Phase II (subcutaneous) (888) 825-5249 )RUPRUHLQIRUPDWLRQDERXWDVSHFL¿FPHGLFLQHLQWKHUHSRUWSOHDVHFDOOWKHWHOHSKRQHQXPEHUOLVWHG Medicines in Development Biotechnology 2011 3 Biotechnology Medicines in Development AUTOIMMUNE DISORDERS Product Name Sponsor Product Indication Development Phase Category atacicept EMD Serono recombinant SLE Phase III (TACI-lg) Rockland, MA fusion (800) 283-8088 Zymogenetics protein (206) 442-6000 Seattle, WA ------------------------------------------------ --------------------------------- lupus nephritis Phase I (800) 283-8088 (206) 442-6000 AZ01 Allozyne interferon multiple sclerosis Phase I (peginterferon beta) Seattle, WA (206) 518-5700 BAFF antibody Eli Lilly mAb rheumatoid arthritis, SLE Phase III (tabalumab) Indianapolis, IN (see also cancer, other) (800) 545-5979 ------------------------------------------------ --------------------------------- multiple sclerosis Phase II (800) 545-5979 baminercept Biogen Idec recombinant multiple sclerosis Phase I/II Weston, MA fusion (781) 464-2000 protein Benlysta® GlaxoSmithKline mAb SLE Phase II belimumab Rsch. Triangle Park, NC (see also blood, transplantation) (888) 825-5249 (subcutaneous) Human Genome Sciences (301) 309-8504 Rockville, MD BHT-3009 Bayhill Therapeutics DNA multiple sclerosis Phase II completed Palo Alto, CA vaccine (650) 320-2800 BIIB 017 Biogen Idec interferon relapsing multiple sclerosis Phase III (PEG-interferon Weston, MA (Fast Track) (781) 464-2000 beta-1a) BT-061 Abbott Laboratories mAb rheumatoid arthritis Phase II Abbott Park, IL (see also skin) (847) 937-6100 Biotest www.biotest.de Dreieich, Germany CAM 3001 AstraZeneca mAb rheumatoid arthritis Phase II (mavrilimumab) Wilmington, DE (800) 236-9933 CSL (301) 398-0000 Victoria, Australia MedImmune Gaithersburg, MD Campath® Genzyme mAb relapsing-remitting multiple Phase III alemtuzumab Cambridge, MA sclerosis (617) 679-2000 (intravenous) (Fast Track) (see also cancer, transplantation) 4 Medicines in Development Biotechnology 2011 Biotechnology Medicines in Development AUTOIMMUNE DISORDERS Product Name Sponsor Product Indication Development Phase Category CNTO-136 Janssen Biotech mAb lupus nephritis, rheumatoid arthritis Phase II (sirukumab) Horsham, PA (800) 526-7736 daclizumab Biogen Idec mAb multiple sclerosis—relapsing forms Phase III Weston, MA (781) 464-2000 epratuzumab Immunomedics mAb SLE Phase III Morris Plains, NJ (Fast Track) (973) 605-8200 UCB (see also cancer) Smyrna, GA fezakinumab 3¿]HU mAb rheumatoid arthritis Phase II (ILV-094) New York, NY (see also skin) (860) 732-5156 GBR-500 Glenmark Pharmaceuticals mAb multiple sclerosis Phase I Mumbai, India (see also digestive) gevokizumab XOMA mAb Behcet’s syndrome, Phase II (Orphan Drug) Berkeley, CA rheumatoid arthritis (510) 204-7200 (see also cardiovascular, diabetes) GSK315234 GlaxoSmithKline mAb rheumatoid arthritis Phase II Rsch. Triangle Park, NC (888) 825-5249 GSK1223249 GlaxoSmithKline mAb multiple sclerosis Phase I Rsch. Triangle Park, NC (see also neurologic) (888) 825-5249 Humira® Abbott Laboratories mAb rheumatoid arthritis Phase III adalimumab Abbott Park, IL (combination therapy) (847) 937-6100 (see also digestive, other) IL-17 antibody Eli Lilly mAb rheumatoid arthritis Phase II (ixekizumab) Indianapolis, IN (see also skin) (800) 545-5979 Ilaris® Novartis Pharmaceuticals mAb systemic juvenile idiopathic arthritis Phase III canakinumab East Hanover, NJ (see also cardiovascular, diabetes, (888) 669-6682 (Orphan Drug) musculoskeletal, respiratory) interferon beta-1-a EMD Serono interferon multiple sclerosis Phase I extended release Rockland, MA (800) 283-8088 Flamel Technologies Cedex, France Medicines in Development Biotechnology 2011 5 Biotechnology Medicines in Development AUTOIMMUNE DISORDERS Product Name Sponsor Product Indication Development Phase Category KB003 KaloBios Pharmaceuticals mAb rheumatoid arthritis Phase II Palo Alto, CA (650) 843-1897 MEDI-545 AstraZeneca mAb SLE Phase II (sifalimumab) Wilmington, DE (see also other) (800) 236-9933 Medarex (609) 430-2880 Princeton, NJ (301) 398-0000 MedImmune Gaithersburg, MD MEDI-546 AstraZeneca mAb scleroderma Phase I (anti-IFNalphaR mAb) Wilmington, DE (800) 236-9933 Medarex (301) 298-0000 Princeton, NJ MedImmune Gaithersburg, MD MEDI-551 AstraZeneca mAb scleroderma Phase I (anti-CD19 mAb) Wilmington, DE (see also cancer) (800) 236-9933 MedImmune (301) 298-0000 Gaithersburg, MD MEDI-570 AstraZeneca mAb SLE Phase I (anti-ICOS mAb) Wilmington, DE (800) 236-9933 MedImmune (301) 298-0000 Gaithersburg, MD NN8209 Novo Nordisk mAb rheumatoid arthritis Phase II (anti-C5aR) Princeton, NJ (609) 987-5800 NN8226 Novo Nordisk mAb rheumatoid arthritis Phase II (anti-IL-20 antibody) Princeton, NJ (609) 987-5800 NN8555 Novo Nordisk mAb rheumatoid arthritis Phase II Princeton, NJ (see also digestive) (609) 987-5800 NN8828 Novo Nordisk mAb rheumatoid arthritis Phase I (anti-IL-21
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