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美国2011年开发中的关节炎新药

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美国2011年开发中的关节炎新药 2011 Arthritis M E D I C I N E S I N D E V E L O P M E N T F O R Report P R E S E N T E D B Y A M E R I C A ’ S B I O P H A R M A C E U T I C A L R E S E A R C H C O M P A N I E S America’s biopharmaceutical research companies arecurrently developing 198 medici...
美国2011年开发中的关节炎新药
2011 Arthritis M E D I C I N E S I N D E V E L O P M E N T F O R Report P R E S E N T E D B Y A M E R I C A ’ S B I O P H A R M A C E U T I C A L R E S E A R C H C O M P A N I E S America’s biopharmaceutical research companies arecurrently developing 198 medicines to help themore than 50 million Americans afflicted with at least one of the 100 different musculoskeletal disorders, including arthritis. All of the medicines are either in clinical trials or awaiting review by the U.S. Food and Drug Administration. Arthritis is the most common cause of disability in the United States. Each year, it is responsible for 44 million outpatient doctor visits, nearly 1 million hospitalizations, and nearly 10,000 deaths. And it costs the American economy nearly $128 billion annually in direct medical costs and indirect costs, such as lost wages and productivity. By 2030, it is estimated that the number of Americans with some form of diagnosed arthritis will increase to more than 67 million. “As the baby boomer generation ages, advances in research and the development of more effective and safer treatments are critical to helping improve the quality of life for millions of people with arthritis,” said John Howard Klippel, M.D., president and CEO of the Arthritis Foundation. New medicines today in the research and development pipeline offer hope of reducing the human and economic costs of the many musculoskeletal disorders affecting Americans. They include: • 67 for rheumatoid arthritis that affects about 1.3 million American adults. • 23 for osteoporosis that affects 10 million people, 80 percent of whom are women. • 19 for lupus which affects an estimated 1.5 million Americans. • 19 for osteoarthritis, the most common form of arthritis, affecting nearly 27 million Americans. • 15 for musculoskeletal pain that affects the muscles, ligaments, tendons, and bones. • 9 for fibromyalgia which affects 3 million to 6 million Americans. Examples of some medicines now being tested to treat musculoskeletal disorders include: • A new monoclonal antibody in development for lupus modulates B-cells that produce antibodies against the body’s own cells and tissue, causing the immune system to turn on itself. • A medicine in development for rheumatoid arthritis (RA) that inhibits two types of an enzyme that are key components in signaling activation of cytokines and growth factors that are elevated in patients with RA. • A potential first-in-class medicine in development for pain associated with osteoarthritis that is an inhibitor of a gene-encoding protein that plays a role in inflam - matory pain. Researching and developing new medicines remains a risky investment and lengthy process—costing, on average, $1.2 billion, including the cost of failures, and taking between 10–15 years to bring a new medicine to patients. But advances in our understanding of diseases and how to treat them have allowed America’s biopharmaceutical research companies to conduct the cutting-edge research needed to reduce the destructive toll of arthritis and other musculoskeletal disorders and to allow more patients to lead healthier, happier, more productive lives. John J. Castellani President and CEO PhRMA Biopharmaceutical Research Companies are Developing Nearly 200 Medicines for the Most Common Chronic Health Problem in the United States MEDICINES AND VACCINES IN DEVELOPMENT FOR ARTHRITIS* * Some medicines are l is ted in more than one category. Other Spondylitis Duchenne Muscular Dystrophy Behcet’s Syndrome Gout Lupus Muscle Disorders Osteoarthritis Rheumatoid Arthritis Raynaud’s Disease Pain Psoriatic Arthritis Scleroderma Osteoporosis 6 Fibromyalgia 9 3 7 19 11 19 67 4 15 7 7 6 22 23 2 M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 Medicines in Development for Arthritis B E H C E T ’ S S Y N D R O M E Product Name Company Indication Development Status* apremilast Celgene Behcet’s syndrome Phase II Summit, NJ (see also psoriatic arthritis, (908) 673-9000 rheumatoid arthritis, spondylitis) gevokizumab XOMA Behcet’s syndrome Phase II (XOMA052) Berkeley, CA (see also rheumatoid arthritis) (510) 204-7200 Veldona® Amarillo Biosciences Behcet’s syndrome Phase II interferon-alpha Amarillo, TX (see also fibromyalgia) (806) 376-1741 lozenge (Orphan Drug) D U C H E N N E M U S C U L A R D Y S T R O P H Y Product Name Company Indication Development Status ACE-031 Acceleron Pharma Duchenne muscular dystrophy Phase II (Orphan Drug) Cambridge, MA (617) 649-9200 ataluren Genzyme Duchenne muscular dystrophy Phase II/III (PTC124) Cambridge, MA (Fast Track) (617) 252-7500 (Orphan Drug) PTC Therapeutics (908) 222-7000 South Plainfield, NJ eteplirsen AVI BioPharma Duchenne muscular dystrophy Phase II (AVI-4658) Bothell, WA (425) 354-5038 (Orphan Drug) GSK2402968 GlaxoSmithKline Duchenne muscular dystrophy Phase III (antisense Rsch. Triangle Park, NC (888) 825-5249 oligonucleotide) Prosensa (Orphan Drug) Leiden, The Netherlands idebenone Santhera Pharmaceuticals Duchenne muscular dystrophy Phase III (Orphan Drug) Charlestown, MA (see also other) (617) 886-5161 muscular dystrophy Asklepios Duchenne muscular dystrophy Phase I gene therapy BioPharmaceutical (919) 968-2727 Chapel Hill, NC F I B R O M Y A L G I A Product Name Company Indication Development Status AGN-XX/YY ACADIA Pharmaceuticals fibromyalgia Phase II (rezatomidine) San Diego, CA (858) 558-2871 Allergan (800) 433-8871 Irvine, CA Cymbalta® Eli Lilly juvenile primary fibromyalgia Phase III duloxetine Indianapolis, IN syndrome (800) 545-5979 droxidopa Chelsea Therapeutics fibromyalgia Phase II Charlotte, NC (704) 341-1516 * For more information about a specific medicine in this report, please call the telephone number listed. 3M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 F I B R O M Y A L G I A Product Name Company Indication Development Status flupirtine Adeona Pharmaceuticals fibromyalgia Phase II Ann Arbor, MI (734) 332-7800 Meda Pharmaceuticals (732) 564-2200 Somerset, NJ Lyrica® CR Pfizer fibromyalgia Phase II/III pregabalin New York, NY (860) 723-5156 (controlled-release) Neupro® UCB fibromyalgia Phase II rotigotine Smyrna, GA (770) 970-7500 transdermal TNX-102 TONIX Pharmaceuticals fibromyalgia syndrome Phase II (cyclobenzaprine New York, NY (212) 980-9155 very low dose) Veldona® Amarillo Biosciences fibromyalgia Phase II interferon-alpha Amarillo, TX (see also Behcet’s syndrome) (806) 376-1741 lozenge Vimpat® UCB fibromyalgia Phase II completed lacosamide Smyrna, GA (770) 970-7500 G O U T Product Name Company Indication Development Status Arcalyst® Regeneron Pharmaceuticals gout Phase III rilonacept Tarrytown, NY (877) 734-6777 BCX-4208 BioCryst Pharmaceuticals gout Phase II Birmingham, AL (205) 444-4600 Ilaris® Novartis Pharmaceuticals gouty arthritis application submitted canakinumab East Hanover, NJ (see also osteoarthritis, (888) 669-6682 (subcutaneous) rheumatoid arthritis) lesinurad Ardea Biosciences gout Phase II San Diego, CA (858) 652-6500 MBX-102 Metabolex gout Phase II (arhalofenate) Hayward, CA (510) 293-8800 NU1618 Nuon Therapeutics gout Phase II (tranilast/allopurinol) San Mateo, CA (650) 645-1800 pegadricase 3SBio gout Phase I Shenyang, China www.3sbio.com L U P U S Product Name Company Indication Development Status A-623 Anthera Pharmaceuticals systemic lupus erythematosus Phase II Hayward, CA (510) 856-5600 AGS-009 Argos Therapeutics systemic lupus erythematosus Phase I Durham, NC (919) 287-6300 AMG 557 Amgen systemic lupus erythematosus Phase I Thousand Oaks, CA (800) 772-6436 4 M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 L U P U S Product Name Company Indication Development Status AMG 811 Amgen systemic lupus erythematosus Phase I Thousand Oaks, CA (800) 772-6436 atacicept EMD Serono systemic lupus erythematosus Phase III (anti-Blys/anti-APRIL Rockland, MA (800) 283-8088 fusion protein) BAFF antibody Eli Lilly systemic lupus erythematosus Phase III (LY2127399) Indianapolis, IN (see also rheumatoid arthritis) (800) 545-5979 Benlysta® GlaxoSmithKline systemic lupus erythematosus Phase II belimumab Rsch. Triangle Park, NC (see also other) (888) 825-5249 (subcutaneous) Human Genome Sciences (301) 309-8504 Rockville, MD CDP-7657 Biogen Idec systemic lupus erythematosus Phase I (CD40L) Cambridge, MA (617) 679-2000 CNTO-136 Centocor Ortho Biotech lupus Phase II (sirukumab) Horsham, PA (see also rheumatoid arthritis) (610) 651-6000 DV-1179 Dynavax Technologies systemic lupus erythematosus Phase I Berkeley, CA (877) 848-5100 epratuzumab Immunomedics systemic lupus erythematosus Phase III Morris Plains, NJ (Fast Track) (973) 605-8200 UCB Smyrna, GA forigerimod Cephalon systemic lupus erythematosus Phase III (CEP-33457) Frazer, PA (610) 344-0200 laquinimod Teva Neuroscience systemic lupus erythematosus Phase II North Wales, PA (800) 838-2872 MEDI-545 AstraZeneca systemic lupus erythematosus Phase II (anti-IFN-alpha Wilmington, DE (800) 236-9933 mAb) Medarex (609) 430-2880 Princeton, NJ (301) 298-0000 MedImmune Gaithersburg, MD MEDI-570 AstraZeneca systemic lupus erythematosus Phase I (anti-ICOS mAb) Wilmington, DE (301) 298-0000 MedImmune Gaithersburg, MD Orencia® Bristol-Myers Squibb systemic lupus erythematosus Phase II/III abatacept Princeton, NJ (see also rheumatoid arthritis) (212) 546-4000 (intravenous) PF-04236921 Pfizer lupus Phase I New York, NY (see also rheumatoid arthritis) (860) 732-5156 RG7415 Genentech systemic lupus erythematosus Phase II (rontalizumab) South San Francisco, CA (800) 626-3553 SBI-087 Emergent BioSolutions systemic lupus erythematosus Phase I (PF-05230895) Rockville, MD (see also rheumatoid arthritis) (301) 795-1800 Pfizer (860) 732-5156 New York, NY 5M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 M U S C L E D I S O R D E R S Product Name Company Indication Development Status AMG 745 Amgen muscular atrophy Phase I Thousand Oaks, CA (800) 772-6436 arbaclofen XenoPort muscle spasticity Phase II placarbil Santa Clara, CA www.xenoport.com (XP19986) Botox® Allergan muscle spasticity application submitted onabotulinum Irvine, CA (714) 246-4500 toxin A -------------------------------------------------------------------------------------- (Orphan Drug) muscle spasm Phase III (714) 246-4500 CK-2017357 Cytokinetics muscle fatigue Phase II South San Francisco, CA (650) 624-3000 Dysport® Tercica focal spasticity of upper and lower Phase III abobotulinum Brisbane, CA limb in adults and children (650) 624-4900 toxin A for injection GSK2245840 GlaxoSmithKline muscular atrophy Phase I (SIRT1 protein Rsch. Triangle Park, NC (888) 825-5249 stimulant) GTx-024 GTx muscular atrophy Phase II completed Memphis, TN (901) 523-9700 IPX-056 Impax Laboratories muscle spasticity in patients with Phase III (baclofen Hayward, CA multiple sclerosis (510) 240-6000 extended-release) LY2495655 Eli Lilly muscular atrophy Phase II (anti-myostatin Indianapolis, IN (800) 545-5979 mAb) nabilone Valeant Pharmaceuticals muscle spasticity Phase II International (800) 548-5100 Irvine, CA nabiximols Otsuka America muscle spasticity Phase II Pharmaceutical (800) 562-3974 Rockville, MD O S T E O A R T H R I T I S Product Name Company Indication Development Status Ampion™ Ampio Pharmaceuticals osteoarthritis Phase I Greenwood Village, CO (303) 418-1000 BI 113823 Boehringer Ingelheim osteoarthritis Phase I Pharmaceuticals (800) 243-0127 Ridgefield, CT CG-100649 CG Pharmaceuticals inflammation associated with Phase I Emeryville, CA osteoarthritis (510) 594-8200 fibroblast growth EMD Serono osteoarthritis Phase I factor-18 Rockland, MA (see also other) (800) 283-8088 6 M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 O S T E O A R T H R I T I S Product Name Company Indication Development Status IBU-PC PLx Pharma pain and inflammation associated Phase II Houston, TX with osteoarthritis (713) 842-1249 Ilaris® Novartis Pharmaceuticals osteoarthritis Phase II canakinumab East Hanover, NJ (see also gout, rheumatoid arthritis) (888) 669-6682 (intra-arterial) IP-880 Iroko Pharmaceuticals osteoarthritis Phase I Philadelphia, PA (267) 546-3003 IP-889 Iroko Pharmaceuticals osteoarthritis Phase III Philadelphia, PA (267) 546-3003 LT-NS001 Logical Therapeutics osteoarthritis Phase II/III (naproxen etemesil) Waltham, MA (781) 290-0900 MEDI-578 AstraZeneca osteoarthritic pain Phase I (anti-NGF mAb) Wilmington, DE (800) 236-9933 MedImmune (301) 298-0000 Gaithersburg, MD naproxcinod NicOx osteoarthritis application submitted Sophia Antipolis, France www.nicox.com osteoarthritis Eli Lilly osteoarthritis Phase II compound Indianapolis, IN (800) 545-5979 (LY2828360) SAR113945 sanofi-aventis osteoarthritis Phase I (IKK-ß inhibitor) Bridgewater, NJ (800) 633-1610 SAR114137 sanofi-aventis osteoarthritic pain Phase I (cathespin S/K Bridgewater, NJ (800) 633-1810 inhibitor) SAR292833 sanofi-aventis osteoarthritic pain Phase I (GRC15300) Bridgewater, NJ (800) 633-1810 TRPV3 antagonist Glenmark Pharmaceuticals Mumbai, India SD-6010 Pfizer osteoarthritis Phase II/III New York, NY (860) 732-5156 SMC021 Emisphere Technologies osteoarthritis Phase III (calcitonin oral) Tarrytown, NY (see also osteoporosis) (914) 347-2220 Novartis Pharmaceuticals (888) 669-6682 East Hanover, NJ Synavive™ Zalicus osteoarthritis Phase II completed prednisone/ Cambridge, MA (see also rheumatoid arthritis) (617) 301-7000 dipyridamole TG-C TissueGene osteoarthritis Phase I Rockville, MD (301) 921-6000 O S T E O P O R O S I S Product Name Company Indication Development Status ACE-011 Acceleron Pharma postmenopausal osteoporosis Phase I (sotatercept) Cambridge, MA (617) 649-9200 Celgene (908) 673-9000 Summit, NJ 7M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 O S T E O P O R O S I S Product Name Company Indication Development Status alendronate Nycomed US osteoporosis application submitted effervescent Melville, NY (631) 454-7677 (EX101) EffRx www.effrx.com Lausanne, Switzerland AMG 785 Amgen postmenopausal osteoporosis Phase II (anti-sclerostin Thousand Oaks, CA (see also other) (800) 772-6436 mAb) Aprela™ Ligand Pharmaceuticals postmenopausal osteoporosis Phase III bazedoxifene/ San Diego, CA prevention (858) 550-7500 conjugated Pfizer (860) 732-5156 estrogens New York, NY AUS-131 Ausio Pharmaceuticals osteoporosis Phase I Cincinnati, OH (513) 731-1600 BA-058 Radius Health osteoporosis Phase II Cambridge, MA (subcutaneous) (617) 551-4700 -------------------------------------------------------------------------------------- osteoporosis Phase I (transdermal) (617) 551-4700 calcitonin oral Tarsa Therapeutics postmenopausal osteoporosis Phase III completed Philadelphia, PA treatment (267) 273-7940 -------------------------------------------------------------------------------------- postmenopausal osteoporosis Phase II prevention (267) 273-7940 DP-001 Deltanoid Pharmaceuticals osteoporosis Phase II Madison, WI (608) 238-7710 GSK768974 GlaxoSmithKline postmenopausal osteoporosis Phase II (parathyroid Rsch. Triangle Park, NC (888) 825-5249 hormone receptor Unigene (973) 265-1100 agonist) Boonton, NJ MER-103 Merrion Pharmaceuticals osteoporosis Phase II completed (oral alendronic Wilmington, DE (910) 799-1847 acid) MK-5442 Merck osteoporosis Phase II (CaSR antagonist) Whitehouse Station, NJ (800) 672-6372 odanacatib Merck male osteoporosis, Phase III (MK-0822) Whitehouse Station, NJ postmenopausal osteoporosis (800) 672-6372 osteoporosis Eli Lilly osteoporosis Phase II compound Indianapolis, IN (800) 545-5979 (LY2541546) PF-04840082 Pfizer osteoporosis treatment and Phase I (DKK1 protein New York, NY prevention (860) 732-5156 inhibitor) Prolia® Amgen male osteoporosis Phase III denosumab Thousand Oaks, CA (see also rheumatoid arthritis) (800) 772-6436 Reclast® Novartis Pharmaceuticals corticosteroid-induced osteoporosis, application submitted zoledronic acid East Hanover, NJ postmenopausal osteoporosis (888) 669-6682 prevention 8 M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 O S T E O P O R O S I S Product Name Company Indication Development Status SMC021 Emisphere Technologies postmenopausal osteoporosis Phase III (calcitonin oral) Tarrytown, NY (see also osteoarthritis) (914) 347-2220 Novartis Pharmaceuticals (888) 669-6682 East Hanover, NJ teriparatide Marina Biotech osteoporosis Phase II intranasal Bothell, WA (425) 908-3600 teriparatide Emisphere Technologies postmenopausal osteoporosis Phase I oral Tarrytown, NY (914) 347-2220 (PTH134) Novartis Pharmaceuticals (888) 669-6682 East Hanover, NJ teriparatide Zosana Pharma osteoporosis Phase II transdermal Fremont, CA (510) 745-1200 (ZP-PTH) ViaDor-hPTH Eli Lilly osteoporosis Phase I (1-34) Indianapolis, IN (800) 545-5979 (teriparatide TransPharma Medical transdermal) Lod, Israel Viviant™ Ligand Pharmaceuticals postmenopausal osteoporosis application submitted bazedoxifene San Diego, CA prevention and treatment (858) 550-7500 Pfizer (860) 732-5156 New York, NY ZT-034 Zelos Therapeutics osteoporosis Phase I (teriparatide) West Conshohocken, PA (intranasal) (610) 260-6045 -------------------------------------------------------------------------------------- osteoporosis Phase I (subcutaneous) (610) 260-6045 P A I N Product Name Company Indication Development Status ABT-652 Abbott Laboratories musculoskeletal pain Phase II Abbott Park, IL (847) 937-6100 BEMA® BioDelivery Sciences back pain, musculoskeletal pain Phase III Buprenorphine International (919) 582-9050 buprenorphine Raleigh, NC transmucosal bupivacaine DURECT back pain Phase II completed transdermal Cupertino, CA (408) 777-1417 chondrocyte tissue ISTO Technologies back pain Phase I grafts St. Louis, MO (314) 995-6049 diclofenac Nuvo Research musculoskeletal pain Phase II transdermal Mississauga, Canada (905) 673-6980 second-generation EXPAREL™ Pacira Pharmaceuticals musculoskeletal pain Phase I bupivacaine Parsippany, NJ (973) 254-3560 extended-release liposome injection 9M E D I C I N E S I N D E V E L O P M E N T F O R Arthritis 2011 P A I N Product Name Company Indication Development Status fulranumab Johnson & Johnson back pain Phase II Pharmaceutical Research (800) 817-5286 & Development Raritan, NJ FX005 Flexion Therapeutics musculoskeletal pain Phase I/II Woburn, MA (781) 897-9977 IDEA-033 IDEA musculoskeletal pain Phase III (ketoprofen Munich, Germany www.idea-ag.de transdermal) JNJ-39439335 Johnson & Johnson musculoskeletal pain Phase I (TRPV1 receptor Pharmaceutical Research (800) 817-5286 antagonist) & Development Raritan, NJ ketoprofen Hisamitsu Pharmaceutical musculoskeletal pain Phase III transdermal Tokyo, Japan www.hisamitsu.co.jp Opana® ER Endo Pharmaceuticals musculoskeletal pain application submitted oxymorphone Chadd’s Farm, PA (abuse-resistant) (610) 558-9800 oxycodone/ Mundipharma back pain Phase II naloxone Basel, Switzerland (203) 588-8000 controlled release Purdue Pharma Stamford, CT tapentadol Johnson & Johnson musculoskeletal pain application submitted controlled-release Pharmaceutical Research & (800) 817-5286 Development Raritan, NJ ZX002 Zogenix back pain Phase III (hydrocodone San Diego, CA (866) 964-3649 controlled-release) P S O R I A T I C A R T H R I T I S Product Name Company Indication Development Status apremilast Celgene psoriatic arthritis Phase III Summit, NJ (see also Behcet’s syndrome, (908) 673-9000 rheumatoid arthritis, spondylitis) Cimzia® UCB psoriatic arthritis Phase III certolizumab pegol Smyrna, GA (see also spondylitis) (770) 970-7500 RG4934 Roche psoriatic arthritis Phase I (anti-IL-17 mAb) Nutley, NJ (973) 235-5000 RO5310074 Roche psoriatic arthritis Phase I Nutley, NJ (973) 235-5000 secukinumab Novartis Pharmaceuticals psoriatic arthritis Phase II East H
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