美国2001年开发中的妇女用新药.

2001 Women N E W 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 Survey P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L C O M P A N I E S Pharmaceutical companies are targeting more than 30diseases that disproportionately affect women, with 358medicines in development for these diseases. In addition, companies are working on 122 medicines for heart disease and stroke—which kill half a million women each year— and 68 medicines for lung cancer, the leading cancer killer of women. (See page 34 for details.) All of the medicines in this new survey by the Pharmaceutical Research and Manufacturers of America are either in clinical trials or awaiting approval by the Food and Drug Administration. Women in the United States can expect to live an average of 79.4 years—more than five years longer than men. The bad news is that they are more susceptible to a number of diseases. Pharmaceutical research is zeroing in on those diseases, as well as on heart disease, cancer, and stroke— the three leading killers of both men and women. Among the medicines in the pipeline are: • 58 for breast cancer, which kills an American woman every 13 minutes. • 33 for ovarian cancer, which kills nearly 14,000 American women each year. • 33 for arthritis, which afflicts at least 26 million American women, accounting for nearly two thirds of all Americans living with arthritis. The disease costs the U.S. economy nearly $65 billion a year, an impact equal to a moderate recession. • 20 for osteoporosis, which costs $13.8 billion a year in hospital and nursing home expenses alone. One of every two women will have an osteoporosis-related fracture at some point in her life. • 31 for diabetes, which affects 8.1 million American women. • 26 for depression, which affects 12.4 million American women. • 14 for multiple sclerosis, which affects some 350,000 Americans. Women develop the disease at a rate almost double that of men. Other medicines in development target lupus, psoriasis, scleroderma, Sjogren’s syndrome, cervical cancer, endometrial cancer, glaucoma, incontinence, urinary tract infections, asthma, chronic bronchitis, Alzheimer’s disease, migraine headache, obstetrical and gynecological disorders, anxiety, irritable bowel syndrome, sepsis and other diseases. Many of the medicines in the pipeline for women use new techniques and attack diseases in novel ways. Examples include: • A vaccine designed to produce antibodies that prevent the bacteria that causes urinary tract infections to attach to bladder cells. • An oral medicine that inhibits an enzyme that regulates the production of two key chemicals that start and sustain the inflammatory process in rheumatoid arthritis. • A medicine that increases the level of a hormone that lupus patients don’t have enough of. • A medicine designed to prevent the activation of the T cells implicated in psoriasis. According to Dr. Freda Lewis-Hall, M.D., a pharmaceutical company researcher, pharmaceutical companies have helped redefine women’s health in recent years. “It’s not just maternal and child health anymore—it’s broader and deeper,” says Dr. Lewis-Hall. “It’s not just life expectancy—it’s how well you live, what kind of quality of life you have. And pharmaceutical companies are doing gender-based research, looking at both the sameness and the differences between men and women. The payoff is that we can deliver better, more targeted medicines to women, now and in the future.” Alan F. Holmer President and CEO PhRMA Women’s Health Revolution Continues with 358 Medicines in the Pipeline for Diseases that Primarily Affect Women MEDICINES AND VACCINES IN DEVELOPMENT FOR WOMEN* * Some medicines are l is ted in more than one category. Sepsis Psychiatric Obstetric/ Gynecologic Neurologic Lung/Respiratory Kidney/Urologic Eye Diabetes Cancer Autoimmune Arthritis/ Musculoskeletal 52 42 82 31 8 18 24 32 43 36 9 Other 13 2 N E W 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 Women 2001 New Medicines in Development for Women A R T H R I T I S / M U S C U L O S K E L E T A L D I S O R D E R S Product Name Company Indication Development Status* 3339 SERM Aventis Pharmaceuticals osteoporosis Phase II Bridgewater, NJ (973) 394-6000 5G1.1 Alexion Pharmaceuticals rheumatoid arthritis Phase II Cheshire, CT (see also autoimmune, (203) 272-2596 kidney/urologic) ABT-963 Abbott Laboratories arthritis Phase I Abbott Park, IL (847) 937-6100 ABX-IL8 Abgenix rheumatoid arthritis Phase II Fremont, CA (see also autoimmune) (510) 608-6500 ALX 1-11 NPS Pharmaceuticals osteoporosis Phase III recombinant Salt Lake City, UT (801) 583-4939 human parathyroid hormone (rhPTH) anakinra Amgen rheumatoid arthritis application submitted Thousand Oaks, CA (800) 772-6436 AnergiX.RA™ Corixa rheumatoid arthritis Phase II Seattle, WA (206) 754-6436 AnervaX.RA™ Corixa rheumatoid arthritis Phase II Seattle, WA (206) 754-5711 bazedoxifene Wyeth-Ayerst Laboratories osteoporosis Phase III (TSE-424) Philadelphia, PA (610) 971-1200 Benefen® MacroChem osteoarthritis Phase II ibuprofen Lexington, MA (781) 862-4003 Bonviva® Roche osteoporosis prevention and Phase III ibandronate Nutley, NJ treatment (973) 235-5000 CDP-870 Pharmacia rheumatoid arthritis Phase II Peapack, NJ (888) 768-5501 clenoliximab/ IDEC Pharmaceuticals rheumatoid arthritis Phase II IDEC-151 San Diego, CA (858) 431-8500 COX 189 Novartis Pharmaceuticals osteoarthritis, rheumatoid arthritis Phase III East Hanover, NJ (888) NOW-NOVA CP-424,391 Pfizer osteoporosis Phase II New York, NY (860) 441-6058 CP-544,439 Pfizer osteoarthritis Phase II New York, NY (860) 441-6058 D2E7 Abbott Laboratories rheumatoid arthritis Phase III Abbott Park, IL (847) 937-6100 etoricoxib Merck osteoarthritis, rheumatoid arthritis Phase III (MK-663) Whitehouse Station, NJ (800) 672-6372 Forcaltonin® Unigene Laboratories osteoporosis Phase III completed (nasal) Fairfield, NJ (973) 882-0860 * For more information about a specific medicine in this report, please call the telephone number listed. 3N E W 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 Women 2001 A R T H R I T I S / M U S C U L O S K E L E T A L D I S O R D E R S Product Name Company Indication Development Status Fortéo™ Eli Lilly osteoporosis application submitted parathyroid Indianapolis, IN (800) 545-5979 hormone (PTH) Fortical® Injection Unigene Laboratories osteoporosis Phase III completed recombinant Fairfield, NJ (973) 882-0860 salmon calcitonin HuMax-CD4 Medarex rheumatoid arthritis Phase II Princeton, NJ (see also autoimmune) (609) 430-2880 inhaled Inhale Therapeutic Systems osteoporosis Phase I parathyroid San Carlos, CA (650) 631-3100 hormone (PTH) IR 501 Immune Response rheumatoid arthritis Phase II completed therapeutic Carlsbad, CA (760) 431-7080 vaccine ISIS 104838 ISIS Pharmaceuticals rheumatoid arthritis Phase I Carlsbad, CA (see also autoimmune) (760) 931-9200 lasofoxifene Pfizer osteoporosis Phase III New York, NY (860) 441-6058 Miacalcin Novartis Pharmaceuticals osteoporosis application submitted Nasal Spray East Hanover, NJ (888) NOW-NOVA calcitonin-salmon micellar paclitaxel Angiotech Pharmaceuticals rheumatoid arthritis Phase I/II Vancouver, British Columbia (see also autoimmune) (604) 221-7676 ML-3000 Forest Laboratories osteoarthritis Phase III New York, NY (800) 947-5227 nabumetone Q GlaxoSmithKline osteoarthritis Phase III Philadelphia, PA (888) 825-5249 Rsch. Triangle Park, NC oral calcitonin Unigene Laboratories osteoporosis Phase I/II Fairfield, NJ (973) 882-0860 ORG 39141 Organon rheumatoid arthritis in clinical trials West Orange, NJ (800) 241-8812 osteoprotegerin Amgen osteoporosis Phase I (OPG) Thousand Oaks, CA (800) 772-6436 parecoxib Pharmacia arthritis application submitted Peapack, NJ (888) 768-5501 Pennsaid® Topical Dimethaid Research osteoarthritis application submitted Solution Markham, Ontario (905) 415-1446 topical diclofenac pralnacasan Aventis Pharmaceuticals rheumatoid arthritis Phase II (VX-740) Bridgewater, NJ (617) 444-6100 Vertex Pharmaceuticals Cambridge, MA Prempro™ Wyeth-Ayerst Laboratories osteoporosis (lower dosage form) in clinical trials conjugated Philadelphia, PA (see also neurologic, (610) 971-1200 estrogens/ obstetric/gynecologic) medroxyprogesterone acetate 4 N E W 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 Women 2001 A R T H R I T I S / M U S C U L O S K E L E T A L D I S O R D E R S Product Name Company Indication Development Status Prograf Fujisawa Healthcare rheumatoid arthritis Phase III tacrolimus Deerfield, IL (800) 888-7704 r-IFNB-1a Serono rheumatoid arthritis Phase II Norwell, MA (800) 283-8088 r-TBP-1 Serono rheumatoid arthritis Phase II Norwell, MA (800) 283-8088 SB 273005 GlaxoSmithKline osteoporosis, rheumatoid arthritis Phase I (dual alpha-4 Philadelphia, PA (see also lung/respiratory) (888) 825-5249 integrin antagonist) Rsch. Triangle Park, NC SB 683698 GlaxoSmithKline rheumatoid arthritis Phase I Philadelphia, PA (see also lung/respiratory) (888) 825-5249 Rsch. Triangle Park, NC SomatoKine® INSMED osteoporosis Phase II Richmond, VA (see also diabetes) (804) 565-3022 sTNF-RI Amgen rheumatoid arthritis Phase II soluble tumor Thousand Oaks, CA (800) 772-6436 necrosis factor-a receptor type 1 Synvisc Genzyme Biosurgery osteoarthritis Phase I (for hip) Cambridge, MA (617) 252-7500 TACE inhibitor DuPont Pharmaceuticals rheumatoid arthritis Phase II Wilmington, DE (302) 992-5000 tibolone Organon osteoporosis application submitted West Orange, NJ (see also obstetric/gynecologic) (800) 241-8812 trimegestone/ Wyeth-Ayerst Laboratories osteoporosis Phase III 17ß-estradiol Philadelphia, PA (see also obstetric/gynecologic) (610) 971-1200 trimegestone/ Wyeth-Ayerst Laboratories osteoporosis Phase III Premarin® Philadelphia, PA (see also obstetric/gynecologic) (610) 971-1200 conjugated estrogens valdecoxib Pfizer osteoarthritis, rheumatoid arthritis application submitted New York, NY (888) 768-5501 Pharmacia Peapack, NJ Vitaxin™ MedImmune rheumatoid arthritis Phase I Gaithersburg, MD (301) 417-0770 zoledronic acid Novartis Pharmaceuticals osteoporosis Phase II East Hanover, NJ (888) NOW-NOVA 5N E W 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 Women 2001 A U T O I M M U N E D I S E A S E S Product Name Company Indication Development Status Where to find additional autoimmune disorders—medicines in development for rheumatoid arthritis are listed under Arthritis/Musculoskeletal Disorders; medicines for diabetes are listed under Diabetes. 5G1.1 Alexion Pharmaceuticals systemic lupus erythematosus Phase II Cheshire, CT (see also arthritis/musculoskeletal, (203) 272-2596 kidney/urologic) ABX-IL8 Abgenix psoriasis Phase II Fremont, CA (see also arthritis/musculoskeletal) (510) 608-6500 Amevive™ Biogen moderate-to-severe chronic plaque application submitted alefacept Cambridge, MA psoriasis (617) 679-2000 AnergiX-MS™ Corixa multiple sclerosis Phase II Seattle, WA (206) 754-5711 Antegren® Biogen multiple sclerosis Phase III natalizumab Cambridge, MA (617) 679-2000 Elan Pharmaceuticals South San Francisco, CA Aslera™ Genelabs Technologies systemic lupus erythematosus Phase III completed prasferone Redwood City, CA (650) 369-9500 (Orphan Drug) Avonex® Biogen secondary progressive multiple Phase III interferon beta-1a Cambridge, MA sclerosis (617) 679-2000 (Orphan Drug) Avonex® Biogen multiple sclerosis Phase I interferon beta-1a Cambridge, MA (617) 679-2000 (inhaled version) Inhale Therapeutic Systems San Carlos, CA Betaseron® Berlex Laboratories secondary progressive application submitted interferon beta-1b Montville, NJ multiple sclerosis (510) 655-8730 Chiron Emeryville, CA BIRB 796 Boehringer Ingelheim psoriasis Phase II Pharmaceuticals (203) 798-9988 Ridgefield, CT CBP-1011 Inkine Pharmaceutical idiopathic thrombocytopenic purpura Phase III Blue Bell, PA (215) 283-6850 Copaxone® TEVA Pharmaceuticals USA primary-progressive Phase III copolymer-1 North Wales, PA multiple sclerosis (215) 591-3000 cyclosporine Allergan treatment of moderate to severe Phase III ophthalmic Irvine, CA keratoconjunctivitis sicca (dry eye) with or without Sjogren’s syndrome Gamimune N Bayer, Pharmaceutical multiple sclerosis Phase III immunoglobulin Division (203) 812-2000 West Haven, CT human anti-TGF Genzyme General scleroderma (diffuse systemic) Phase I/II beta MAb Cambridge, MA (617) 252-7570 HuMax-CD4 Medarex psoriasis Phase II Princeton, NJ (see also arthritis/musculoskeletal) (609) 430-2880 6 N E W 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 Women 2001 A U T O I M M U N E D I S E A S E S Product Name Company Indication Development Status IC747 ICOS psoriasis Phase I Bothell, WA (425) 485-1900 IDEC 114/MAb, B7 IDEC Pharmaceuticals psoriasis Phase II San Diego, CA (858) 431-8500 IFNAR-2 Serono multiple sclerosis Phase I Norwell, MA (800) 283-8088 IR-208 Immune Response multiple sclerosis Phase I/II Carlsbad, CA (760) 431-7080 ISIS 2302 topical ISIS Pharmaceuticals psoriasis Phase II Carlsbad, CA (760) 931-9200 ISIS 104838 ISIS Pharmaceuticals psoriasis Phase II Carlsbad, CA (see also arthritis/musculoskeletal) (760) 931-9200 J695 Abbott Laboratories autoimmune diseases Phase II Abbott Park, IL (847) 937-6100 LJP-394 La Jolla Pharmaceutical systemic lupus erythematosus Phase III (Orphan Drug) San Diego, CA (888) 305-8787 lymphotoxin beta Biogen autoimmune diseases Phase I receptor Cambridge, MA (617) 679-2000 MDX-44 Medarex psoriasis Phase I/II Princeton, NJ (609) 430-2880 MEDI-507 BioTransplant psoriasis Phase II siplizumab Charlestown, MA (301) 417-0770 MedImmune Gaithersburg, MD micellar paclitaxel Angiotech Pharmaceuticals multiple sclerosis, psoriasis Phase I/II Vancouver, British Columbia (see also arthritis/musculoskeletal) (604) 221-7676 NBI-5788 Neurocrine Biosciences multiple sclerosis Phase II San Diego, CA (858) 658-7600 Neurodex Avanir Pharmaceuticals pathological laughing or crying Phase III San Diego, CA associated with multiple sclerosis (858) 622-5200 (emotional lability or pseudobulbar effect) (see also neurological) Nuvion™ Protein Design Labs psoriasis Phase I/II SMART anti-CD3 Fremont, CA (510) 574-1632 antibody ONTAK® Ligand Pharmaceuticals psoriasis Phase II denileukin diftitox San Diego, CA (858) 550-7500 PEGr-IFNB-1a Serono multiple sclerosis Phase I Norwell, MA (800) 283-8088 Provigil® Cephalon chronic fatigue immune Phase II modafinil West Chester, PA dysfunction syndrome (610) 344-0200 (see also other) PVAC™ Corixa psoriasis Phase II Seattle, WA (206) 754-5711 Genesis Auckland, New Zealand 7N E W 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 Women 2001 A U T O I M M U N E D I S E A S E S Product Name Company Indication Development Status Rebif® Serono relapsing-remitting multiple sclerosis application submitted human interferon Norwell, MA (800) 283-8088 beta 1-a -------------------------------------------------------------------------------------- early treatment of multiple sclerosis, Phase III secondary-progressive multiple (800) 283-8088 sclerosis Remicade® Centocor psoriasis Phase II infliximab Malvern, PA (610) 651-6000 SMART™ Protein Design Labs psoriasis Phase I anti-gamma Fremont, CA (510) 579-1632 interferon antibody Targretin® Capsules Ligand Pharmaceuticals psoriasis Phase II bexarotene San Diego, CA (see also cancer) (858) 550-7500 Veldona® Amarillo Biosciences Sjogren’s syndrome Phase III interferon-alpha Amarillo, TX (806) 376-1741 lozenges -------------------------------------------------------------------------------------- fibromyalgia Phase II (806) 376-1741 Xanelim™ Genentech moderate-to-severe psoriasis Phase III efalizumab South San Francisco, CA (650) 225-1000 XOMA Berkeley, CA Zenapax® Protein Design Labs Behcet’s disease, psoriasis Phase II daclizumab Fremont, CA (see also diabetes, lung/respiratory) (510) 574-1632 C A N C E R Product Name Company Indication Development Status ALVAC-B7.1 National Cancer Institute ovarian Phase I vaccine Bethesda, MD N C I T R I A L (800) 422-6237 Annamycin Antigenics breast Phase I/II annamycin New York, NY (212) 332-4774 Aptosyn™ Cell Pathways metastatic breast Phase I/II exisuland Horsham, PA (215) 706-3800 with Xeloda capecitabine Avastin Genentech metastatic breast Phase III MAb South San Francisco, CA (650) 225-1000 bevacizumab National Cancer Institute breast Phase I/II (MAb VEGF) Bethesda, MD N C I T R I A L (800) 422-6237 bryostatin 1 National Cancer Institute breast, cervical, ovarian Phase I/II Bethesda, MD N C I T R I A L (800) 422-6237 8 N E W 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 Women 2001 C A N C E R Product Name Company Indication Development Status BUDR National Cancer Institute cervical Phase II Bethesda, MD N C I T R I A L Neopharm (800) 422-6237 Lake Forest, IL CAI National Cancer Institute ovarian Phase II Bethesda, MD N C I T R I A L (800) 422-6237 cancer vaccine Therion Biologics breast, ovarian Phase I Cambridge, MA (617) 876-7779 CDC 117 Celgene breast Phase I Warren, NJ (858) 558-7500 CEA-CIDE™ Immunomedics ovarian Phase I Morris Plains, NJ (973) 605-8200 CEA-SCAN® Immunomedics breast Phase III Morris Plains, NJ (973) 605-8200 Clariscan™ Nycomed Amersham imaging agent for the detection Phase II NC100150 Princeton, NJ of breast cancer (609) 514-6000 DOXIL® ALZA Pharmaceuticals breast Phase III doxorubicin HCl Mountain View, CA (650) 564-5000 liposome Schering-Plough injection Madison, NJ E1A Targeted Genetics ovarian Phase I lipid complex Seattle, WA (206) 623-7612 EF-5 National Cancer Institute breast, cervical Phase I Bethesda, MD N C I T R I A L (800) 422-6237 Evista® Eli Lilly breast cancer prevention Phase III raloxifene Indianapolis, IN (800) 545-5979 flavopiridol National Cancer Institute breast Phase I/II Bethesda, MD N C I T R I A L Aventis Pharmaceuticals (800) 422-6237 Bridgewater, NJ G-3139 Genta breast Phase I/II completed Berkeley Heights, NJ (908) 286-9800 GD0039 GLYCODesign chemoprotective agent in advanced Phase I/II Toronto, Ontario breast cancer patients receiving (416) 593-6027 combination chemotherapy GEM® 231 Hybridon breast, cervical, endometrial, Phase I Cambridge, MA ovarian (617) 679-5500 Gemzar® Eli Lilly breast, ovarian Phase III gemcitabine Indianapolis, IN (800) 545-5979 H11 Viventia Biotech breast Phase I Toronto, Ontario (416) 291-1277 HER-2/neu Corixa breast Phase I Seattle, WA (206) 616-1823 9N E W 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 Women 2001 C A N C E R Product Name Company Indication Development Status Herceptin® National Cancer Institute breast, endometrial, ovarian Phase II/III trastuzumab Bethesda, MD N C I T R I A L Genentech (800) 422-6237 South San Francisco, CA HPV16 E6 and E7 National Cancer Institute cervical Phase I peptide vaccine Bethesda, MD N C I T R I A L (800) 422-6237 human papilloma- Merck cervical cancer prevention Phase II virus Whitehouse Station, NJ (see also obstetric/gynecologic) (800) 672-6372 (HPV) vaccine Hycamtin™ GlaxoSmithKline ovarian (first-line therapy) Phase III topotecan Philadelphia, PA (888) 825-5249 Rsch. Triangle Park, NC IM862 Cytran breast, ovarian Phase II oglufamide sodium Kirkland, WA (425) 889-8822 Incel™ Vertex Pharmaceuticals breast, ovarian Phase II biricodar dictrate Cambridge, MA (617) 444-6100 INGN 201 National Cancer Institute breast, ovarian Phase I (adenoviral-p53) Bethesda, MD N C I T R I A L Introgen (800) 422-6237 Austin, TX INGN 241 Introgen breast in clinical trials (adenoviral-mda7) Austin, TX (512) 708-9310 interleukin-12 National Cancer Institute ovarian Phase I/II Bethesda, MD N C I T R I A L Genetics Institute (800) 422-6237 Cambridge, MA irofulven MGI Pharma endometrial, ovarian Phase II (MGI-114) Minnetonka, MN (800) 562-5580 (Orphan Drug) ----------------------------------------------------------