2010 Medicines in development for Diabetes

2010 Diabetes 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 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 Diabetes is increasing at an alarming rate inAmerica. Each day, approximately 4,110 peopleare diagnosed with diabetes. To help fight this potentially devastating disease, America’s pharmaceu tical research and biotech nology companies are working on 235 new medicines to treat diabetes and related conditions. All of the medicines in this report are either in clinical trials or awaiting approval by the U.S. Food and Drug Administration. According to the American Diabetes Association (ADA), diabetes affects more than 20 million Americans—about 8 percent of the U.S. population—and a third are unaware they have the disease. Unfortunately, the rate of new cases and the death rate due to diabetes has been rising. The rate of new cases rose by more than 90 percent among adults over the last 10 years, according to a 2008 study by the U.S. Centers for Disease Control and Prevention. Since 1987, the death rate due to diabetes has increased by 45 percent, even as death rates due to heart disease, stroke, and cancer have declined. With the stakes this high, America’s pharmaceutical companies are committed to developing new medicines to treat diabetes. According to the ADA, most Americans with diabetes have type 2, in which relative insulin deficiency combines with the body failing to properly use insulin. Between 5 percent and 10 percent of Americans with diabetes have type 1, in which the body fails to produce insulin. Diabetes is associated with an increased risk for a number of serious, sometimes life-threatening, complications. These include heart disease and stroke, high blood pressure, blindness, kidney disease, nervous system disease, amputations, dental disease, complications of pregnancy, and sexual dysfunction. For example, adults with diabetes have heart disease death rates about two to four times higher than adults without diabetes. While lifestyle changes such as weight loss combined with moderate physical activity can reduce the risk for developing type 2 diabetes, medicines have been critical to improving and lengthening the lives of those suffering from it. The new medicines in development include: • A once-weekly medicine that is an analog of a natural human hormone that plays a significant role in blood sugar regulation. • A drug that addresses the underlying cause of type 2 diabetes by modulating genes responsible for insulin sensitization. • A once-daily medicine that selectively inhibits a protein associated with glucose metabolism, but not other related proteins associated with other biologic activity. While diabetes remains a formidable foe, America’s pharmaceutical research and biotechnology companies are continuing their efforts to develop novel and more effective therapies to contain the disease and increase patients’ quality of life. Billy Tauzin President and CEO PhRMA Biopharmaceutical Companies Developing a Record 235 Medicines to Treat Diabetes and Related Conditions MEDICINES IN DEVELOPMENT FOR DIABETES* *Some medicines are l is ted in more than one category. Diabetes-Related Conditions Type 2 Diabetes Type 1 Diabetes Unspecified/Other Diabetes 23 24 144 59 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 Diabetes 2010 Medicines in Development for Diabetes D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status* 11ßHSD Bristol-Myers Squibb diabetes in clinical trials inhibitor Princeton, NJ (212) 546-4000 376501 GlaxoSmithKline type 2 diabetes Phase I (PPAR gamma Rsch. Triangle Park, NC (888) 825-5249 partial agonist) 625019 GlaxoSmithKline metabolic syndrome, Phase I (PPAR agonist) Rsch. Triangle Park, NC type 2 diabetes (888) 825-5249 756050 GlaxoSmithKline type 2 diabetes Phase II Rsch. Triangle Park, NC (888) 825-5249 1292263 GlaxoSmithKline type 2 diabetes Phase I (bombesin Rsch. Triangle Park, NC (888) 825-5249 receptor agonist) 1362885 GlaxoSmithKline type 2 diabetes Phase I completed (glycogen Rsch. Triangle Park, NC (888) 825-5249 phosphorylase inhibitor) 1614235 GlaxoSmithKline type 2 diabetes Phase I (SGLT1 inhibitor) Rsch. Triangle Park, NC (888) 825-5249 Afrezza™ MannKind type 1 diabetes, type 2 diabetes application submitted insulin inhalation Valencia, CA (661) 775-5300 AI-401 AutoImmune type 1 diabetes (prevention) Phase III Pasadena, CA (626) 792-1235 Albulin™ Teva Pharmaceuticals USA type 1 diabetes, type 2 diabetes Phase I albumin/insulin North Wales, PA (215) 591-3000 aleglitazar Roche type 2 diabetes Phase III (RG1439) Nutley, NJ (973) 235-5000 alogliptin Takeda Pharmaceuticals type 2 diabetes application submitted North America (once-daily treatment) (224) 554-6500 Deerfield, IL alogliptin/ Takeda Pharmaceuticals diabetes Phase III metformin North America (224) 554-6500 (fixed-dose Deerfield, IL combination) alogliptin/ Takeda Pharmaceuticals type 2 diabetes application submitted pioglitazone North America (224) 554-6500 (fixed-dose Deerfield, IL combination) Alveair™ Coremed diabetes Phase I inhaled insulin Lake Bluff, IL (847) 549-9098 AMG 151 Amgen type 2 diabetes Phase I Thousand Oaks, CA (805) 447-1000 Array BioPharma (877) 633-2436 Boulder, CO * 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status AMG 221 Amgen type 2 diabetes Phase I Thousand Oaks, CA (805) 447-1000 AMG 222 Amgen type 2 diabetes Phase II Thousand Oaks, CA (805) 447-1000 APD597 Arena Pharmaceuticals type 2 diabetes Phase I San Diego, CA (858) 453-7200 Johnson & Johnson (800) 817-5286 Pharmaceutical Research & Development Raritan, NJ AR9281 Arete Therapeutics type 2 diabetes Phase II Hayward, CA (510) 785-7060 ARI-2243 Arisaph Pharmaceuticals type 2 diabetes Phase I Boston, MA (617) 292-3322 ASP-1941 Astellas Pharma US type 2 diabetes Phase II Deerfield, IL (800) 695-4321 ASP-4178 Astellas Pharma US type 2 diabetes Phase I Deerfield, IL (800) 695-4321 AT1391 Altea Therapeutics type 1 diabetes Phase I/II (daily insulin Atlanta, GA (404) 835-6310 skin patch) -------------------------------------------------------------------------------------- type 2 diabetes Phase I (404) 835-6310 ATL-844 PGxHealth type 2 diabetes Phase II New Haven, CT (877) 274-9432 Avandamet® XR GlaxoSmithKline type 2 diabetes Phase III rosiglitazone/ Rsch. Triangle Park, NC (888) 825-5249 metformin extended-release AZD1656 AstraZeneca type 2 diabetes Phase II Wilmington, DE (800) 236-9933 -------------------------------------------------------------------------------------- type 1 diabetes Phase I (800) 236-9933 AZD4017 AstraZeneca type 2 diabetes Phase I Wilmington, DE (800) 236-9933 AZD6370 AstraZeneca type 2 diabetes Phase II Wilmington, DE (800) 236-9933 AZD6714 AstraZeneca type 2 diabetes Phase I Wilmington, DE (800) 236-9933 AZD7687 AstraZeneca type 2 diabetes Phase I Wilmington, DE (800) 236-9933 AZD8329 AstraZeneca type 2 diabetes Phase I Wilmington, DE (800) 236-9933 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status AZP-01 Alize Pharma type 2 diabetes Phase I Ecully, France (800) 545-5979 Eli Lilly Indianapolis, IN basal insulin Eli Lilly diabetes Phase I analog Indianapolis, IN (800) 545-5979 BGP-15 N-Gene Research type 2 diabetes Phase II Laboratories (212) 605-0225 New York, NY BI-10773 Boehringer Ingelheim type 2 diabetes Phase II Pharmaceuticals (800) 243-0127 Ridgefield, CT BLX 1002 BEXEL Pharmaceuticals type 2 diabetes Phase II Union City, CA (510) 324-0015 Byetta® Amylin Pharmaceuticals type 2 diabetes in adolescents Phase III exenatide San Diego, CA (858) 552-2200 Eli Lilly (800) 545-5979 Indianapolis, IN canagliflozin Johnson & Johnson type 2 diabetes Phase III Pharmaceutical Research (800) 817-5286 & Development (908) 607-1950 Raritan, NJ Mitsubishi Pharma America Warren, NJ CCR2 antagonist Bristol-Myers Squibb diabetes in clinical trials Princeton, NJ (212) 546-4000 CCX140 ChemoCentryx type 2 diabetes Phase II Mountain View, CA (650) 210-2900 cetilistat Norgine type 2 diabetes in clinically obese Phase II Amsterdam, The Netherlands patients www.norgine.com CORT001 Cortendo metabolic syndrome Phase II Halmstad, Sweden www.cortendo.com CRx-401 CombinatoRx type 2 diabetes Phase II Cambridge, MA (617) 301-7000 dapagliflozin AstraZeneca type 2 diabetes Phase III (SGLT2 inhibitor) Wilmington, DE (800) 236-9933 Bristol-Myers Squibb (212) 546-4000 Princeton, NJ dapagliflozin/ AstraZeneca type 2 diabetes Phase III metformin Wilmington, DE (212) 546-4000 (fixed-dose Bristol-Myers Squibb -------------------------------------------------------------------------------------- combination) Princeton, NJ type 2 diabetes Phase I (with extended-release metformin) (212) 546-4000 DC9703 Obio Pharmaceutical type 2 diabetes Phase I (Omega Bio-Pharma) www.obiopharma.com Wilmington, DE 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status Diamyd® Diamyd type 1 diabetes Phase III autoimmune Pittsburgh, PA (412) 770-1310 diabetes vaccine (Orphan Drug) DiaPep277® Andromeda Biotech latent autoimmune diabetes Phase II Ness Ziona, Israel in adults DSP-8658 Dainippon Sumitomo type 2 diabetes Phase I Pharma America (201) 592-2050 Fort Lee, NJ dutogliptin Forest Laboratories type 2 diabetes Phase III New York, NY (800) 947-5227 Phenomix (858) 731-5200 San Diego, CA Enbrel® Amgen metabolic syndrome Phase II etanercept Thousand Oaks, CA (805) 447-1000 EX-1000 Novo Nordisk type 2 diabetes Phase II Princeton, NJ (800) 727-6500 exenatide Amylin Pharmaceuticals type 2 diabetes Phase I completed intranasal San Diego, CA (858) 552-2200 MDRNA (425) 908-3600 Bothell, WA exenatide Alkermes type 2 diabetes application submitted once weekly Cambridge, MA (617) 494-0170 Amylin Pharmaceuticals (858) 552-2200 San Diego, CA (800) 545-5979 Eli Lilly Indianapolis, IN exenatide Amylin Pharmaceuticals type 2 diabetes Phase I/II once weekly San Diego, CA (858) 552-2200 (suspension) Eli Lilly (800) 545-5979 Indianapolis, IN exenatide Altea Therapeutics type 2 diabetes Phase I transdermal Atlanta, GA (404) 835-6310 Amylin Pharmaceuticals (858) 552-2200 San Diego, CA (800) 545-5979 Eli Lilly Indianapolis, IN FGF-21 variant Eli Lilly type 2 diabetes Phase I Indianapolis, IN (800) 545-5979 Glinsuna™ Elixir Pharmaceuticals type 2 diabetes Phase III completed mitiglinide Cambridge, MA (617) 995-7000 GLP-1 Emisphere Technologies type 2 diabetes Phase I/II completed (oral) Cedar Knolls, NJ (973) 532-8000 GLP-1 FC Eli Lilly type 2 diabetes Phase III Indianapolis, IN (800) 545-5979 GLP-1 PEG Eli Lilly type 2 diabetes Phase II Indianapolis, IN (800) 545-5979 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status glucokinase Bristol-Myers Squibb diabetes in clinical trials activator Princeton, NJ (212) 546-4000 GS 9667 Gilead Sciences diabetes/hypertriglyceridemia Phase I Foster City, CA (800) 445-3235 HDV-insulin Diasome Pharmaceuticals type 2 diabetes Phase II Conshohocken, PA (609) 923-9443 HE3286 Harbor BioSciences type 2 diabetes Phase II San Diego, CA (858) 587-9333 HSD016 Pfizer diabetes Phase I New York, NY (860) 732-5156 IL-1 ß antibody Eli Lilly type 2 diabetes Phase II Indianapolis, IN (800) 545-5979 Ilaris® Novartis Pharmaceuticals type 2 diabetes Phase II/III canakinumab East Hanover, NJ (888) 669-6682 INCB-13739 Incyte type 2 diabetes Phase II Wilmington, DE (302) 498-6700 INCB-20817 Incyte type 2 diabetes Phase I completed Wilmington, DE (302) 498-6700 INGAP peptide Exsulin type 1 diabetes, type 2 diabetes Phase II completed Minneapolis, MN www.exsulin.com insulin inhalation Baxter Healthcare diabetes Phase I Deerfield, IL (800) 422-9837 insulin inhalation MicroDose Therapeutx diabetes Phase I completed Monmouth Junction, NJ (732) 355-2100 insulin oral Emisphere Technologies type 2 diabetes Phase I/II Cedar Knolls, NJ (973) 532-8000 insulin oral Generex Biotechnology type 1 diabetes Phase III Toronto, Canada (416) 364-2551 insulin transdermal Dermisonics type 1 diabetes, type 2 diabetes Phase I Irvine, CA (888) 401-3376 INT-131 InteKrin Therapeutics type 2 diabetes Phase II Los Altos, CA (650) 941-5501 INT-747 Intercept Pharmaceuticals type 2 diabetes Phase II New York, NY (646) 747-1000 Intesulin™ Coremed diabetes Phase I insulin oral Lake Bluff, IL (847) 772-6868 ISIS-113715 Isis Pharmaceuticals type 2 diabetes Phase II Carlsbad, CA (combination therapy) (800) 679-4747 ISIS-GCGRrx Isis Pharmaceuticals type 2 diabetes Phase I Carlsbad, CA (800) 679-4747 ISIS-SGLT2rx Isis Pharmaceuticals type 2 diabetes Phase I Carlsbad, CA (800) 679-4747 ITCA 650 Intarcia Therapeutics type 2 diabetes Phase II Hayward, CA (510) 782-7800 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status Januvia® Merck type 2 diabetes (monotherapy) Phase III sitagliptin Whitehouse Station, NJ (800) 672-6372 -------------------------------------------------------------------------------------- type 2 diabetes (in adolescents) Phase I (800) 672-6372 JNJ-16268110 Johnson & Johnson type 2 diabetes Phase II Pharmaceutical Research (800) 817-5286 & Development Raritan, NJ JNJ-38431055 Johnson & Johnson type 2 diabetes Phase I Pharmaceutical Research (800) 817-5286 & Development Raritan, NJ JTT-654 Akros Pharma type 2 diabetes Phase I Princeton, NJ (609) 919-9570 Japan Tobacco www.jt.com Tokyo, Japan K-111 Kowa Pharmaceuticals type 2 diabetes Phase II America (334) 288-1288 Montgomery, AL KRP-104 ActivX Biosciences type 2 diabetes Phase II La Jolla, CA (858) 558-5558 LCQ908 Novartis Pharmaceuticals type 2 diabetes Phase II East Hanover, NJ (888) 669-6682 lisofylline DiaKine Therapeutics type 1 diabetes (newly diagnosed) Phase I Charlottesville, VA (434) 975-2001 LixiLan sanofi-aventis type 2 diabetes Phase I lixisenatide/ Bridgewater, NJ (800) 633-1610 insulin glargine combination lixisenatide sanofi-aventis type 2 diabetes Phase III (AVE0010; Bridgewater, NJ (800) 633-1610 GLP1 agonist) LX-4211 Lexicon Pharmaceuticals type 2 diabetes Phase II The Woodlands, TX (281) 863-3000 LY2405319 Eli Lilly type 2 diabetes Phase I Indianapolis, IN (800) 545-5979 LY2599506 Eli Lilly type 2 diabetes Phase II (glukokinase Indianapolis, IN (800) 545-5979 activator) (OSI) Prosidion (631) 962-2000 Melville, NY LY2605541 Eli Lilly type 2 diabetes Phase II Indianapolis, IN (800) 545-5979 MAR701 Marcadia Biotech type 2 diabetes Phase I Carmel, IN (317) 566-2266 MB07803 Metabasis Therapeutics type 2 diabetes Phase II completed La Jolla, CA (858) 587-2770 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status MBX-102 Johnson & Johnson type 2 diabetes Phase II/III completed (JNJ-39659100) Pharmaceutical Research (800) 817-5286 & Development (510) 293-8800 Raritan, NJ Metabolex Hayward, CA MBX-2044 Johnson & Johnson type 2 diabetes Phase II Pharmaceutical Research (800) 817-5286 & Development (510) 293-8800 Raritan, NJ Metabolex Hayward, CA MBX-2982 Metabolex type 2 diabetes Phase II Hayward, CA (510) 293-8800 Metgluna™ Elixir Pharmaceuticals type 2 diabetes Phase III mitiglinide/ Cambridge, MA (617) 995-7000 metformin (fixed-dose combination) Mitoglitazone™ Metabolic Solutions type 2 diabetes Phase II completed MSDC-0160 Development (616) 464-5071 Kalamazoo, MI MK-0599 Merck type 2 diabetes Phase I Whitehouse Station, NJ (800) 672-6372 MK-0893 Merck type 2 diabetes Phase II Whitehouse Station, NJ (800) 672-6372 MK-0941 Merck type 2 diabetes Phase II Whitehouse Station, NJ (800) 672-6372 MK-1006 Merck diabetes Phase I Whitehouse Station, NJ (800) 672-6372 MK-3102 Merck type 2 diabetes Phase I Whitehouse Station, NJ (800) 672-6372 MK-3577 Merck type 2 diabetes Phase II Whitehouse Station, NJ (800) 672-6372 MK-4074 Merck diabetes Phase I Whitehouse Station, NJ (800) 672-6372 MK-8245 Merck type 2 diabetes Phase II Whitehouse Station, NJ (800) 672-6372 MKC253 Mannkind type 2 diabetes Phase I (glucagon-like Valencia, CA (661) 775-5300 peptide-1 inhalation) Naturlose™ Spherix type 2 diabetes Phase III tagatose Bethesda, MD (301) 897-2540 NBI-6024 Neurocrine Biosciences type 1 diabetes Phase II San Diego, CA (858) 658-7600 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 Diabetes 2010 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status NN1250 Novo Nordisk type 1 diabetes, type 2 diabetes Phase III (degludec) Princeton, NJ (800) 727-6500 NN1952 Novo Nordisk diabetes Phase I Princeton, NJ (800) 727-6500 NN5401 Novo Nordisk type 1 diabetes, type 2 diabetes Phase III (degludec plus) Princeton, NJ (800) 727-6500 NN9068 Novo Nordisk type 2 diabetes Phase I Princeton, NJ (800) 727-6500 NN9535 Novo Nordisk type 2 diabetes Phase II (semaglutide) Princeton, NJ (800) 727-6500 NN9924 Novo Nordisk type 2 diabetes Phase I Princeton, NJ (800) 727-6500 NN9925 Novo Nordisk type 2 diabetes Phase I Princeton, NJ (800) 727-6500 Norditropin® Novo Nordisk insulin resistance Phase I somatropin Princeton, NJ (800) 727-6500 NOX-700 Medinox type 2 diabetes Phase I Carlsbad, CA (760) 603-8989 NP-500 Napo Pharmaceuticals metabolic syndrome, Phase I South San Francisco, CA type 2 diabetes (650) 616-1900 OAP-189 Pfizer type 2 diabetes Phase I New York, NY (860) 732-5156 Ondero® Boehringer Ingelheim type 2 diabetes Phase III linagliptin Pharmaceuticals (800) 243-0127 Ridgefield, CT otelixizumab GlaxoSmithKline type 1 diabetes Phase III (Orphan Drug) Rsch. Triangle Park, NC (888) 825-5249 Tolerx (617) 354-8100 Cambridge, MA PEG-encapsulated Novocell type 1 diabetes Phase I/II islet cell San Diego, CA (858) 455-3708 transplantation Pfizer (860) 732-5156 therapy New York, NY PF-4620110 Bristol-Myers Squibb type 2 diabetes Phase I (DGAT) Princeton, NJ (212) 546-4000 Pfizer (860) 732-5156 New York, NY PF-4856883 Pfizer type 2 diabetes Phase I New York, NY (860) 732-5156 PF-4937319 Pfizer type 2 diabetes Phase I New York, NY (860) 732-5156 PF-4971729 Pfizer type 2 diabetes Phase II New York, NY (860) 732-5156 PF-5212389 Pfizer diabetes Phase I New York, NY (860) 732-5156 10 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Sponsor Indication Development Status PLX-204 Plexxikon type 2 diabetes Phase II Berkeley, CA (510) 647-4000 Prochymal™ Osiris Therapeutics type 1 diabetes Phase II human Columbia, MD (443) 545-1800 mesenchymal stem cell therapy pyrazinoyl- SuperGen type 2 diabetes Phase II guanidine Dublin, CA (925) 560-0100 Qnexa® VIVUS type 2 diabetes in obese patients Phase II phentermine/ Mountain View, CA (650) 934-5200 topiramate combination RG4929 Roche type 2 diabetes Phase I Nutley, NJ (973) 235-5000 RG7089 Roche type 2 diabetes Phase I Nutley, NJ (973) 235-5000 RG7201 Roche type 2 diabetes Phase II Nutley, NJ (973) 235-5000 RG7234 Roche type 2 diabetes Phase I Nutley, NJ (973) 235-5000 RG7426 Bayhill Therapeutics type 1 diabetes Phase I/II (BHT-3021) Palo Alto, CA (800) 626-3553 Genentech South San Francisco, CA rHuPH20 Halozyme Therapeutics type 1 diabetes, type 2 diabetes Phase II San Diego, CA (858) 794-8889 RO-4998452 Roche type 2 diabetes Phase II Nutley, NJ (973) 235-5000 SAR16127 sanofi-aventis diabete