美国2001年开发中的老年病新药

2001 Older Americans 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 Promising new treatments for Alzheimer’s disease,osteoporosis, arthritis, sepsis and Parkinson’s diseaseare among the 261 medicines in the pharmaceutical pipeline for these and other debilitating diseases of aging—in addition to 122 medicines for heart disease and stroke and 402 for cancer, the leading killers of seniors (See page 24.) Following up previous surveys of medicines in the pipeline for heart disease and cancer, a new survey by the Pharmaceutical Research and Manufacturers of America found 261 medicines in development for other diseases of aging by 120 companies. These include: • 44 for respiratory and lung disorders, the fourth leading cause of death among the elderly; • 23 for diabetes, the sixth leading cause of death among people age 65 and older; • 20 for depression, which affects about 2 million older adults, or 6 percent of the population age 65 and older; • 21 for Alzheimer’s disease, which currently afflicts 4 million Americans and will afflict 14 million by mid-century unless a cure or prevention is found; • 15 for osteoporosis, which afflicts 10 million Americans; and • 13 for Parkinson’s disease, which affects 1.5 million Americans, including one of every 100 people over age 60. Other medicines in the pipeline target urinary incontinence, macular degeneration, glaucoma, Crohn’s disease, arthritis, pain, prostate disease, sepsis, sexual dysfunction, psoriasis, and other diseases. These potential medicines, all of which are either in human clinical trials or awaiting final approval by the Food and Drug Administration, promise to continue the enormous improvements in both life expectancy and quality of life that seniors have experienced over the past half century. Here are some examples of the progress made over the past few decades: • In 1950, a 65-year-old could expect to live only about 14 more years; a person reaching 65 today can expect to live nearly 18 more years. • The death rate from heart disease among people ages 65 to 84 is less than half of what it was in 1950, and the death rate from stroke has been reduced even more. • Chronic disability among the elderly is declining, and fewer Americans are entering nursing homes, according to a study by Duke University researchers. Since 1994, disability among the elderly has dropped 2.6 percent a year, and the number of nursing home residents declined by 200,000 in the past decade. • Advances in treatments for arthritis, diabetes, depression and other diseases has improved the quality of life for many and empowered seniors to lead active, independent lives. Many of the medicines in the pipeline use pioneering research and technology to attack the diseases of aging. For example: • An innovative drug for Parkinson’s disease uses dopamine- secreting retinal pigment epithelial cells to deliver dopamine to regions of the brain that are deficient in this vital chemical. • A vaccine for rheumatoid arthritis is designed to stimulate an immune response that may be able to prevent the body from turning on itself, potentially halting the progress of this autoimmune disease. This promising research on diseases of aging comes at a time when the elderly population is growing at an unprecedented rate. By 2030, some 20 percent of the population will be 65 or older, and by 2100, the over-100 crowd is expected to number 5.3 million. And the aging population has rising expectations of what old age will bring. According to a survey by the Alliance for Aging Research, nearly two out of three Americans want to live to be 100 years old and expect to benefit from the many scientific breakthroughs on the horizon. Our aging populace—and their rising expectations—underline the need for prescription drug coverage for seniors, who expect and deserve access to the fruits of medical research. Medicare drug coverage must be crafted in a way that gives seniors access to the medicines of today and provides incentives for companies to discover the medicines of tomorrow. Alan F. Holmer President and CEO PhRMA New Drugs in Development Increase to 785 For Diseases Affecting Older Americans 0 5 10 15 20 25 Alzheimer's Disease/ Dementias Bladder/Kidney Disorders Depression Diabetes Eye Disorders Gastrointestinal Disorders Intermittent Claudication Osteoarthritis Osteoporosis Parkinson's Disease Prostate Disease Respiratory/Lung Disorders Rheumatoid Arthritis Sepsis Skin Conditions Sexual Dysfunction Other 21 14 20 23 12 19 2 8 15 13 5 44 22 8 11 16 15 18Pain MEDICINES IN DEVELOPMENT FOR OLDER AMERICANS* *Some medicines are l isted in more than one category. 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 Older Americans 2001 New Medicines in Development for Older Americans A L Z H E I M E R ’ S D I S E A S E / D E M E N T I A S Product Name Company Indication Development Status* ALCAR Sigma-Tau Pharmaceuticals Alzheimer’s disease in early Phase III acetyl-L-carnitine Gaithersburg, MD onset patients (800) 447-0169 HCl Ampalex™ Cortex Pharmaceuticals Alzheimer’s disease Phase II CX516 Irvine, CA (949) 727-3157 AN-1792 Antigenics Alzheimer’s disease Phase II New York, NY (610) 971-1200 Elan Pharmaceuticals South San Francisco, CA Wyeth-Ayerst Laboratories Philadelphia, PA Aricept® Eisai vascular dementia Phase III donepezil Teaneck, NJ (888) 274-2378 hydrochloride aripiprazole Bristol-Myers Squibb dementia Phase III Princeton, NJ (212) 546-4000 Otsuka America Pharmaceutical Rockville, MD Exelon® Capsules Novartis Pharmaceuticals vascular dementia and mild Phase III rivastigmine tartrate East Hanover, NJ cognitive impairment (888) NOW-NOVA M100907B Aventis Pharmaceuticals behavioral and psychological Phase II 5HT2 antagonist Bridgewater, NJ symptoms of dementia (973) 394-6000 Marinol Unimed Pharmaceuticals Alzheimer’s disease and Phase II Buffalo Grove, IL disturbed behavior (847) 282-5400 memantine Forest Laboratories Alzheimer’s disease Phase III New York, NY (see also pain) (800) 947-5227 Neurobiological Technologies Richmond, CA NDD 094 Novartis Pharmaceuticals Alzheimer’s disease Phase II East Hanover, NJ (888) NOW-NOVA Neotrofin™ NeoTherapeutics Alzheimer’s disease Phase II/III leteprinim Irvine, CA (see also Parkinson’s disease) (949) 788-6700 potassium (AIT-082) NGD 97-1 Neurogen Alzheimer’s disease Phase II Branford, CT (203) 488-8201 Pfizer New York, NY phenserine Axonyx Alzheimer’s disease Phase III tartrate New York, NY (212) 688-4770 * 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 Older Americans 2001 A L Z H E I M E R ’ S D I S E A S E / D E M E N T I A S Product Name Company Indication Development Status Premarin® Wyeth-Ayerst Laboratories Alzheimer’s disease Phase III conjugated Philadelphia, PA (610) 971-1200 estrogens tablets Reminyl® Janssen Research Foundation mixed and vascular dementia Phase III galantamine Titusville, NJ (908) 704-4000 R.W. Johnson Pharmaceutical -------------------------------------------------------------------------------------- Research Institute dementia with Lewy bodies Phase III Raritan, NJ (908) 704-4000 Risperdal® Janssen Research Foundation psychotic disturbances in dementia application submitted risperidone Titusville, NJ (908) 704-4000 R.W. Johnson Pharmaceutical Research Institute Raritan, NJ SB 271046 GlaxoSmithKline cognition impairment Phase I (5HT6 receptor Philadelphia, PA (888) 825-5249 antagonist) Rsch. Triangle Park, NC SL 25.1188 Sanofi-Synthelabo Alzheimer’s disease Phase I New York, NY (212) 551-4000 SR 57667 Sanofi-Synthelabo Alzheimer’s disease Phase I New York, NY (see also Parkinson’s disease) (212) 551-4000 SR 57746 Sanofi-Synthelabo Alzheimer’s disease Phase III New York, NY (212) 551-4000 -------------------------------------------------------------------------------------- dementia, Alzheimer’s type Phase II (212) 551-4000 Zyprexa® Eli Lilly Alzheimer’s dementia Phase III olanzapine Indianapolis, IN (800) 545-5979 B L A D D E R / K I D N E Y D I S O R D E R S Product Name Company Indication Development Status 5G1.1 humanized Alexion Pharmaceuticals nephritis Phase II anti-C5 MAb Cheshire, CT (see also rheumatoid arthritis) (203) 272-2596 AZD0947 AstraZeneca urinary incontinence Phase II Wilmington, DE (800) 456-3669 AZD5106 AstraZeneca urinary incontinence Phase I Wilmington, DE (800) 456-3669 darifenacin Pfizer overactive bladder Phase III New York, NY (860) 441-6058 duloxetine Eli Lilly stress urinary incontinence Phase III Indianapolis, IN (see also depression) (800) 545-5979 Factive GlaxoSmithKline urinary tract infections application submitted (oral formulation) Philadelphia, PA (888) 825-5249 Rsch. Triangle Park, NC Hectorol™ Bone Care International secondary hyperparathyroidism application submitted doxercalciferol Madison, WI (608) 662-7800 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 Older Americans 2001 B L A D D E R / K I D N E Y D I S O R D E R S Product Name Company Indication Development Status Invanz Merck urinary tract infections Phase III/application Whitehouse Station, NJ (see also respiratory/lung disorders) submitted (800) 672-6372 ML-07 Milkhaus Laboratory urinary incontinence Phase II Boxford, MA (401) 273-4555 NAD-299 AstraZeneca urinary incontinence Phase II Wilmington, DE (see also depression) (800) 456-3669 RTX™ Afferon urinary incontinence Phase II resiniferatoxin Wayne, PA (610) 971-2555 SB 223412 GlaxoSmithKline urinary incontinence Phase I (NK3 receptor Philadelphia, PA (see also respiratory/lung disorders) (888) 825-5249 antagonist) Rsch. Triangle Park, NC (S)-oxybutynin Sepracor urinary incontinence Phase III Marlborough, MA (508) 357-7300 trospium chloride Interneuron Pharmaceuticals urinary incontinence Phase III Lexington, MA (781) 861-8444 D E P R E S S I O N Product Name Company Indication Development Status AR-AZ AstraZeneca depression Phase I Wilmington, DE (800) 456-3669 CGP 60829 Novartis Pharmaceuticals major depressive disorder Phase II East Hanover, NJ (888) NOW-NOVA CP-122,721 Pfizer depression Phase II New York, NY (860) 441-6058 CP-448,187 Pfizer depression in clinical trials New York, NY (860) 441-6058 duloxetine Eli Lilly depression Phase III Indianapolis, IN (see also bladder/kidney disorders) (800) 545-5979 GW597599 GlaxoSmithKline depression Phase I (NK1 receptor Philadelphia, PA (888) 825-5249 antagonist) Rsch. Triangle Park, NC GW650250 GlaxoSmithKline depression Phase II (mixed monoamine Philadelphia, PA (888) 825-5249 reuptake inhibitor) Rsch. Triangle Park, NC NAD-299 AstraZeneca depression Phase II Wilmington, DE (see also bladder/kidney disorders) (800) 456-3669 ORG 33062 Organon depression application submitted West Orange, NJ (800) 241-8812 ORG 34167 Organon depression Phase I West Orange, NJ (800) 241-8812 ORG 34517 Organon depression Phase II West Orange, NJ (800) 241-8812 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 Older Americans 2001 D E P R E S S I O N Product Name Company Indication Development Status Paxil® GlaxoSmithKline depression Phase III paroxetine HCI Philadelphia, PA (888) 825-5249 (dispersible tablets) Rsch. Triangle Park, NC (R)-didesmethyl- Sepracor depression Phase II sibutramine Marlborough, MA (508) 357-7300 SB 243213 GlaxoSmithKline depression Phase I (5HT2c receptor Philadelphia, PA (888) 825-5249 antagonist) Rsch. Triangle Park, NC SB 659746A GlaxoSmithKline depression Phase II (SSRI/5HT1a Philadelphia, PA (888) 825-5249 receptor partial Rsch. Triangle Park, NC agonist) (S)-citalopram Forest Laboratories depression application submitted New York, NY (800) 947-5227 SR 58611 Sanofi-Synthelabo severe depression Phase II B3 adreneugic New York, NY (212) 551-4000 receptor agonist SR 142801 Sanofi-Synthelabo major depressive disorder Phase II NK3 receptor New York, NY (212) 551-4000 antagonist substance P Merck depression Phase II antagonist Whitehouse Station, NJ (800) 672-6372 Vestra Pharmacia depression Phase III reboxetine Peapack, NJ (888) 768-5501 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Company Indication Development Status AC2993 Amylin Pharmaceuticals type 2 diabetes Phase II (synthetic exendin-4) San Diego, CA (858) 642-7177 AC2993 LAR Amylin Pharmaceuticals type 2 diabetes Phase I (long-acting release) San Diego, CA (858) 642-7177 Alkermes Cambridge, MA AERx inhaled Aradigm type 1 and type 2 diabetes for Phase II insulin Hayward, CA mealtime dosing (510) 265-9000 Novo Nordisk Pharmaceuticals Princeton, NJ Avandia® GlaxoSmithKline type 2 diabetes application submitted rosiglitazone Philadelphia, PA (888) 825-5249 maleate Rsch. Triangle Park, NC (in combination with insulin) 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 Older Americans 2001 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Company Indication Development Status Exubera™ Aventis Pharmaceuticals type 1 and type 2 diabetes Phase III inhaled insulin Bridgewater, NJ (650) 631-3100 Inhale Therapeutic Systems San Carlos, CA Pfizer New York, NY GI262570 GlaxoSmithKline type 2 diabetes Phase III (PPAR gamma Philadelphia, PA (888) 825-5249 agonist) Rsch. Triangle Park, NC GW427353 GlaxoSmithKline type 2 diabetes Phase I (beta3 adrenergic Philadelphia, PA (888) 825-5249 receptor agonist) Rsch. Triangle Park, NC HMR 1964A Aventis Pharmaceuticals type 1 and type 2 diabetes Phase II/III fast-acting insulin Bridgewater, NJ (973) 394-6000 IDD-676 Institute for Diabetes type 1 and type 2 diabetes Phase II Discovery (203) 315-4000 Branford, CT ingliforib Pfizer type 2 diabetes Phase II New York, NY (860) 441-6058 INS-1 Insmed type 2 diabetes Phase II Richmond, VA (804) 828-6893 insulin detemir Novo Nordisk type 1 and type 2 diabetes Phase III Pharmaceuticals (800) 727-6500 Princeton, NJ insulinotropin Novo Nordisk type 2 diabetes Phase I Pharmaceuticals (800) 727-6500 Princeton, NJ Scios Mountain View, CA KRP-297 Merck type 2 diabetes Phase II Whitehouse Station, NJ (800) 672-6372 Laf 237 Novartis Pharmaceuticals type 2 diabetes in clinical trials East Hanover, NJ (888) NOW-NOVA MBX-102 Metabolex type 2 diabetes Phase I Hayward, CA (510) 293-8800 PKC inhibitor Eli Lilly diabetic complications in Phase III Indianapolis, IN type 1 and type 2 diabetes (800) 545-5979 PNU-182716 Pharmacia type 2 diabetes Phase II Peapack, NJ (888) 768-5501 R149524 Janssen Research Foundation diabetic gastroparesis Phase II Titusville, NJ (908) 704-4000 R.W. Johnson Pharmaceutical Research Institute Raritan, NJ SB 418790 GlaxoSmithKline type 2 diabetes Phase I (beta3 adrenergic Philadelphia, PA (888) 825-5249 receptor agonist) Rsch. Triangle Park, NC 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 Older Americans 2001 D I A B E T E S , T Y P E 1 A N D T Y P E 2 Product Name Company Indication Development Status SomatoKine® Insmed type 1 and type 2 diabetes Phase II Richmond, VA (see also osteoporosis) (804) 828-6893 Symlin™ Amylin Pharmaceuticals type 1 and insulin-treated type 2 application submitted pramlintide San Diego, CA diabetes (858) 642-7177 acetate Xenical® Roche treatment of type 2 diabetes application submitted orlistat Nutley, NJ (973) 235-5000 -------------------------------------------------------------------------------------- prevention of type 2 diabetes Phase III (973) 235-5000 E Y E D I S O R D E R S Product Name Company Indication Development Status AMD Fab Genentech age-related macular degeneration Phase II/III South San Francisco, CA (wet form) (650) 225-1000 anecortave acetate Alcon Laboratories age-related macular degeneration Phase II Fort Worth, TX BetaSite™ InSite Vision glaucoma Phase III completed levobunolol Alameda, CA (510) 865-8800 HGP-2 H.G. Pars Laboratories glaucoma Phase II Concord, MA ISV-205 InSite Vision steroid glaucoma Phase II Alameda, CA (510) 865-8800 memantine Allergan glaucoma Phase III Irvine, CA (800) 433-8871 metipranolol Alcon Laboratories glaucoma application submitted Fort Worth, TX Motexafin Pharmacyclics age-related macular degeneration Phase II Lutetium™ Sunnyvale, CA (408) 774-0330 PhotoPoint™ Miravant Medical age-related macular degeneration Phase III SnET2 Technologies (888) 768-5501 (tin ethyl Santa Barbara, CA etiopurpurin) Pharmacia Peapack, NJ Visudyne™ Novartis Ophthalmics age-related macular degeneration Phase III verteporfin Atlanta, GA (occult without classic choroidal (800) 663-5486 QLT neovascularization) Vancouver, BC Xalatan Pharmacia glaucoma Phase II latanoprost Peapack, NJ (888) 768-5501 (forced flow device) Xalcom Pharmacia glaucoma Phase III latanoprost/timolol Peapack, NJ (888) 768-5501 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 Older Americans 2001 G A S T R O I N T E S T I N A L D I S O R D E R S Product Name Company Indication Development Status ADL 8-2698 Adolor constipation Phase III Exton, PA (484) 595-1500 ALX-0600 NPS Pharmaceuticals short bowel syndrome Phase II glucagon-like Salt Lake City, UT (801) 583-4939 peptide 2 (GLP-2) analog BNP-166 IVAX Crohn’s disease Phase I Miami, FL CAMPYVAX™ Antex Biologics gastritis and diarrhea due to Phase II Campylobacter Gaithersburg, MD Campylobacter infections (301) 590-0129 vaccine C. difficile colitis Genzyme General colitis Phase II toxin binder Cambridge, MA (617) 252-7500 cilansetron Solvay Pharmaceuticals irritable bowel syndrome Phase III Marietta, GA (770) 579-7534 Colirest™ InKine Pharmaceutical Crohn’s disease, ulcerative colitis Phase II medroxypro- Blue Bell, PA (215) 283-6850 gesterone acetate D2E7 Abbott Laboratories Crohn’s disease Phase II Abbott Park, IL (see also rheumatoid arthritis) (847) 937-6100 Entocort™ AstraZeneca Crohn’s disease application submitted budesonide Wilmington, DE (800) 456-3669 modified release capsules Gadolite® Pharmacyclics angiodysplasia of the bowel, application submitted Oral Suspension Sunnyvale, CA diverticulosis (408) 774-0330 HELIVAX™ Antex Biologics peptic ulcers and gastric Phase II Helicobacter pylori Gaithersburg, MD cancers due to Helicobacter (301) 590-0129 vaccine infections IDEC 114/MAb,B7 IDEC Pharmaceuticals Crohn’s disease Phase I San Diego, CA (see also skin conditions) (858) 431-8500 ISIS 2302 ISIS Pharmaceuticals Crohn’s disease Phase III Carlsbad, CA (see also skin conditions) (760) 931-9200 LPD-02 Genentech Crohn’s disease, ulcerative colitis Phase II South San Francisco, CA (650) 225-1000 repifermin Human Genome Sciences ulcerative colitis Phase II Rockville, MD (see also skin conditions) (301) 309-8504 r-IFNB-1a Serono Crohn’s disease Phase II Norwell, MA (see also rheumatoid arthritis) (800) 283-8088 r-TBP-z Serono Crohn’s disease Phase II Norwell, MA (800) 283-8088 SR 48692 Sanofi-Synthelabo irritable bowel syndrome Phase II neurotensin New York, NY (212) 551-4000 antagonist SYNSORB-Cd® SYNSORB Biotech recurrent Clostridium Phase III Calgary, AB difficile-associated diarrhea (403) 283-5900 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 Older Americans 2001 I N T E R M I T T E N T C L A U D I C A T I O N Product Name Company Indication Development Status NM 702 Welfide International intermittent claudication Phase II completed Los Angeles, CA propionyl-L- Sigma-Tau Pharmaceuticals intermittent claudication Phase III carnitine HCl Gaithersburg, MD (800) 447-0169 O S T E O A R T H R I T I S Product Name Company Indication Development Status Benefen™ MacroChem osteoarthritis Phase II ibuprofen Lexington, MA (781) 862-4003 COX 189 Novartis Pharmaceuticals osteoarthritis Phase III East Hanover, NJ (see also pain, rheumatoid arthritis) (888) NOW-NOVA etoricoxib Merck osteoarthritis Phase III (MK-663)