2011 Medicines in Development for Women
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201R1e port 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 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 More Than 800 Medicines Are in Testing for Diseases Disproportionately Affecting American Women merica’s pharmaceutical research and biotech - MEDICINES AND VACCINES IN DEVELOPMENT FOR WOMEN* nology companies are developing 851 medicines Afor diseases that disproportionately affect American women. The medicines in the pipeline for women (either in clinical trials or awaiting review by the Food and Drug Administration) include: • 139 for cancers affecting women, including 91 for breast cancer, 49 for ovarian cancer, and 9 for cervical cancer. • 114 for arthritis/musculoskeletal disorders. Approximately 46 million Americans have some type of arthritis or related condition, and 60 percent of them are female. • 64 for obstetric/gynecologic conditions. • 110 for autoimmune diseases, which strike women three times more than men. • 72 for depression and anxiety. Almost twice as many women as men suffer from these disorders. * Some medicines are listed in more than one category. • 83 for Alzheimer’s disease. Two-thirds (3.4 million) of In separate reports, PhRMA has found that researchers the 5.4 million Americans living with Alzheimer’s are working on 299 medicines for heart disease and today are women. stroke—which kill nearly half a million women each Among the potential new medicines in development year—and 98 medicines for lung cancer, the leading for women: cancer killer of women (see page 60 for details). • A medicine that uses nanotechnology that targets a America’s pharmaceutical research and biotech - cytokine that plays a key role in the inflammatory nology companies continue making exciting progress in process associated with rheumatoid arthritis. the search for new cures and treatments for diseases of special concern to women. We live in an era in which • A first-in-class medicine in development for ovarian we understand ever more about the difference between cancer that induces cell death and reduces cancer the sexes and their health care needs. This knowledge is growth by inhibiting an enzyme responsible for cell inspiring a continuing medical revolution that is bringing division. new hope to women around the world. • A first-in-class medicine in development for migraine that selectively blocks transmission of pain signals to the brain. • A new monoclonal antibody in development for lupus John J. Castellani modulates B-cells that produce antibodies against the President and CEO body’s own cells and tissue, causing the immune PhRMA system to turn on itself. 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* ACE-011 Acceleron Pharma postmenopausal osteoporosis Phase I (sotatercept) Cambridge, MA (617) 649-9200 Celgene (908) 673-9000 Summit, NJ Actemra™ Genentech systemic-onset juvenile idiopathic application submitted tocilizumab South San Francisco, CA arthritis (800) 626-3553 -------------------------------------------------------------------------------------- early-stage rheumatoid arthritis Phase III (800) 626-3553 -------------------------------------------------------------------------------------- rheumatoid arthritis (subcutaneous) Phase III (800) 626-3553 AGN-XX/YY ACADIA Pharmaceuticals fibromyalgia Phase II San Diego, CA (see also gastrointestinal) (858) 558-2871 Allergan (800) 433-8871 Irvine, CA AIN457 Novartis Pharmaceuticals rheumatoid arthritis Phase II (secukinumab) East Hanover, NJ (see also autoimmune) (888) 669-6682 alendroniate Nycomed US osteoporosis application submitted effervescent Melville, NY (631) 454-7677 EffRx Lausanne, Switzerland AMG 167 Amgen osteopenia Phase I Thousand Oaks, CA (800) 772-6436 AMG 785 Amgen postmenopausal fracture, Phase II (anti-sclerostin Thousand Oaks, CA postmenopausal osteoporosis (800) 772-6436 mAb) AMG 827 Amgen rheumatoid arthritis Phase II (mAb) Thousand Oaks, CA (see lung/respiratory) (800) 772-6436 anti-LT alpha Genentech rheumatoid arthritis Phase II (RG-7416) South San Francisco, CA (800) 626-3553 anti-TWEAK Biogen Idec rheumatoid arthritis Phase I (BIIB 023) Cambridge, MA (see also kidney/urologic) (617) 679-2000 Aprela™ Ligand Pharmaceuticals postmenopausal osteoporosis Phase III bazedoxifene/ San Diego, CA prevention (858) 550-7500 conjugated Pfizer (see also obstetric/gynecologic) (860) 732-5156 estrogens New York, NY apremilast Celgene rheumatoid arthritis Phase II Summit, NJ (908) 673-9000 Arcoxia™ Merck rheumatoid arthritis Phase III etoricoxib Whitehouse Station, NJ (800) 672-6372 * For more information about a specific medicine in this report, please call the telephone number listed. 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 Women 2011 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 ARG301 arGentis rheumatoid arthritis Phase I Memphis, TN (901) 818-3262 atripimod Callisto Pharmaceuticals rheumatoid arthritis Phase II completed New York, NY (212) 297-0010 AUS-131 Ausio Pharmaceuticals osteoporosis Phase I Cincinnati, OH (see also obstetric/gynecologic) (513) 731-1600 AVL-92 Avila Therapeutics rheumatoid arthritis Phase I Waltham, MA (781) 891-0086 BA-058 Radius Health osteoporosis Phase II Cambridge, MA (617) 551-4700 BAFF antibody Eli Lilly rheumatoid arthritis Phase III (LY2127399) Indianapolis, IN (see also autoimmune) (800) 545-5979 BG-12 Biogen Idec rheumatoid arthritis Phase II completed (dimethyl fumarate) Cambridge, MA (see also autoimmune) (617) 679-2000 BI 113823 Boehringer Ingelheim osteoarthritis Phase I Pharmaceuticals (800) 243-0127 Ridgefield, CT BMS-817399 Bristol-Myers Squibb rheumatoid arthritis Phase I (CCR1 antagonist) Princeton, NJ (212) 546-4000 BMS-945429 Bristol-Myers Squibb rheumatoid arthritis Phase I (anti-IL6) Princeton, NJ (212) 546-4000 Alder Biopharmaceuticals (425) 205-2900 Bothell, WA calcitonin oral Tarsa Therapeutics postmenopausal osteoporosis Phase III completed Philadelphia, PA treatment (267) 273-7940 -------------------------------------------------------------------------------------- postmenopausal osteoporosis Phase II prevention (267) 273-7940 CAM-3001 AstraZeneca rheumatoid arthritis Phase II (anti-GM-CSFR Wilmington, DE (800) 236-9933 mAb) MedImmune (301) 398-0000 Gaithersburg, MD CCX354 ChemoCentryx rheumatoid arthritis Phase II Mountain View, CA (650) 210-2900 cenplacel-L Celgene Cellular rheumatoid arthritis Phase I/II (PDA-001) Therapeutics (see also autoimmune) (908) 673-9000 Summit, NJ CF101 Can-Fite BioPharma rheumatoid arthritis Phase II Petah-Tikva, Israel (see also eye) www.canfite.com CG-100649 CG Pharmaceuticals inflammation associated with Phase I Emeryville, CA osteoarthritis (510) 594-8200 CH-4051 Chelsea Therapeutics rheumatoid arthritis Phase II Charlotte, NC (704) 341-1516 CNTO-136 Centocor Ortho Biotech rheumatoid arthritis Phase II (sirukumab) Horsham, PA (see also kidney/urologic) (610) 651-6000 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 2011 3 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 DP-001 Deltanoid Pharmaceuticals osteoporosis Phase II Madison, WI (608) 238-7710 droxidopa Chelsea Therapeutics fibromyalgia Phase II Charlotte, NC (see also other) (704) 341-1516 EVT 401 Evotec rheumatoid arthritis Phase I completed North Potomac, MD (240) 683-1199 fezakinumab Pfizer rheumatoid arthritis Phase II (ILV-094) New York, NY (see also autoimmune) (860) 732-5156 fibroblast growth EMD Serono osteoarthritis Phase I factor-18 Rockland, MA (800) 283-8088 flupirtine Adeona Pharmaceuticals fibromyalgia Phase II Ann Arbor, MI (734) 332-7800 Meda Pharmaceuticals (732) 564-2200 Somerset, NJ fostamatinib AstraZeneca rheumatoid arthritis Phase III Wilmington, DE (800) 236-9933 Rigel Pharmaceuticals (650) 624-1100 South San Francisco, CA gevokizumab XOMA rheumatoid arthritis Phase II (XOMA052) Berkeley, CA (see also autoimmune) (510) 204-7200 GSK315234 GlaxoSmithKline rheumatoid arthritis Phase II (oncostatin M mAb) Rsch. Triangle Park, NC (888) 825-5249 GSK768974 GlaxoSmithKline osteoporosis Phase II (parathyroid Rsch. Triangle Park, NC (888) 825-5249 hormone receptor Unigene (973) 265-1100 agonist) Boonton, NJ HE3286 Hollis-Eden rheumatoid arthritis Phase I/II completed Pharmaceuticals (858) 587-9333 San Diego, CA Humira® Abbott Laboratories early rheumatoid arthritis Phase III adalimumab Abbott Park, IL (see also kidney/urologic) (847) 937-6100 IBU-PC PLx Pharma pain and inflammation associated Phase II Houston, TX with osteoarthritis (713) 842-1249 IL-17 antibody Eli Lilly rheumatoid arthritis Phase II (LY2439821) Indianapolis, IN (800) 545-5979 Ilaris® Novartis Pharmaceuticals systemic juvenile idiopathic arthritis Phase III canakinumab East Hanover, NJ (subcutaneous) (888) 669-6682 (see also autoimmune, lung/respiratory) -------------------------------------------------------------------------------------- osteoarthritis Phase II (intra-arterial) (888) 669-6682 IR-raloxifene SCLOR Pharma osteoporosis Phase I completed Bothell, WA (425) 368-1050 JAK-1/JAK-2 Eli Lilly rheumatoid arthritis Phase II (LY3009104) Indianapolis, IN (800) 545-5979 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 Women 2011 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 JNJ-40346527 Johnson & Johnson