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201R0eport 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 Mental Illnesses 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 Pharmaceutical Research Companies Are Developing More Than 300 Medicines to Treat Mental Illnesses merica’s pharmaceutical research and biotech- 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 M E N T A L nology companies are currently developing 313 I L L N E S S E S * Amedicines to help the nearly 60 million American adults today suffering from some form of mental illness— Addictive Disorders 33 from Alzheimer’s disease to depression and from Anxiety Disorders 38 schizophrenia to addictive disorders, such as dependence Attention-Deficit/ 20 on alcohol or drugs. All of the medicines are either in Hyperactivity Disorder Dementias 90 clinical trials or awaiting review by the Food and Drug Depression 71 Administration. Developmental Disorders 6 Over the past half century, pharmaceutical research has Eating Disorders 33 helped transform mental illnesses from misunderstood Personality Disorders 2 causes of shame and fear into often highly treatable con- ditions. For example, medicines for treating depression are Premenstrual Disorders 2 helping thousands of people suffering from this disease live Schizophrenia 54 productive lives. Breakthrough schizophrenia medicines Sleep Disorders 21 enable most patients to be treated in the community rather Other 3 than institutional settings, and medicines for Alzheimer’s * Some medicines are in development for more than one disorder. disease are helping elderly people maintain their inde- pendence longer. Examples of some medicines now being tested to treat Despite such progress, mental illnesses continue to mental illnesses include: exact a heavy human and economic toll. The National • A medicine to potentially treat the varied symptoms Institute of Mental Health (NIMH) estimates that 1 in 4 associated with schizophrenia, with diminished side American adults suffer from a diagnosable mental disor- effects common with current treatments. der. According to the World Health Organization, more than 300 million people worldwide suffer from a mental • A medicine designed to remove beta amyloid protein health disorder. Mental illness, including suicide, accounts from the brain and prevent or reverse progression of for more than 15 percent of the burden of disease in Alzheimer’s disease. established market economies, which is more than the Researching and developing new medicines remains a disease burden caused by all cancers. According to a risky investment and lengthy process—costing, on average, study funded by the NIMH, serious mental illnesses cost $1.3 billion and taking between 10 and 15 years to the United States more than $317 billion annually in lost bring a new medicine to patients. But advances in our wages, health care expenditures and disability benefits. understanding of mental illnesses and how to treat them New medicines today in the research and development have allowed America’s pharmaceutical research and pipeline offer hope of reducing the human and economic biotechnology companies to conduct the cutting-edge costs of mental illnesses. They include: 71 for depression research needed to reduce the destructive toll of these (mood disorders), which affects nearly 21 million Americans; disorders and to allow more patients to lead healthier, 33 for addictive disorders, including dependence on happier, more productive lives. alcohol, tobacco or illicit drugs; 38 medicines for anxiety disorders, which affect more than 40 million adults ages 18 and older; 90 for dementias, including Alzheimer’s disease, which affects more than 5 million Americans; and 54 for schizophrenia, which strikes some 2.4 million David E. Wheadon, M.D. American adults each year. Other potential medicines Senior Vice President, target attention-deficit/hyperactivity disorder, autism, Scientific & Regulatory Affairs eating disorders, personality disorders, premenstrual PhRMA disorders and sleep disorders. Medicines in Development for Mental Illnesses A D D I C T I V E D I S O R D E R S Product Name Sponsor Indication Development Status* 468816 GlaxoSmithKline nicotine dependence Phase II Rsch. Triangle Park, NC (888) 825-5249 618334 GlaxoSmithKline drug dependence Phase I Rsch. Triangle Park, NC (888) 825-5249 AFQ056 Novartis Pharmaceuticals smoking withdrawal Phase I completed East Hanover, NJ (see also developmental disorders) (888) 669-6682 alcohol Eli Lilly alcohol dependence Phase I dependence Indianapolis, IN (800) 545-5979 therapy alcohol Eli Lilly alcohol dependence Phase I dependence Indianapolis, IN (800) 545-5979 therapy ALKS 29 Alkermes alcohol dependence Phase I/II (baclofen/ALKS 33 Cambridge, MA (617) 494-0171 combination) ALKS 33 Alkermes alcohol dependence Phase II Cambridge, MA (617) 494-0171 -------------------------------------------------------------------------------------- drug dependence, Phase I impulse control disorder (617) 494-0171 ARD-1600 Aradigm nicotine dependence Phase I (nicotine Hayward, CA (510) 265-9000 inhalation) CPP-109 Catalyst Pharmaceutical cocaine dependence Phase II (vigabatrin) Coral Gables, FL (Fast Track) (305) 529-2522 DOV-102677 DOV Pharmaceutical alcohol dependence Phase I Little Falls, NJ (732) 907-3600 EMB-001 Embera NeuroTherapeutics cocaine dependence Phase I completed Shreveport, LA (318) 213-0198 KRL-901 Krele Pharmaceuticals alcohol dependence in clinical trials Saddle River, NJ (212) 923-3400 lobeline Yaupon Therapeutics methamphetamine dependence Phase II Radnor, PA (see also ADHD) (610) 975-9290 lofexidine US WorldMeds opioid dependence Phase III Louisville, KY (502) 753-2094 MK-0594 Merck alcohol dependence Phase II Whitehouse Station, NJ (800) 672-6372 MS-166 MediciNova opioid dependence Phase II San Diego, CA (858) 373-1500 * 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 Mental Illnesses 2010 A D D I C T I V E D I S O R D E R S Product Name Sponsor Indication Development Status nalmefene Lundbeck alcohol dependence Phase III Deerfield, IL (800) 455-1141 -------------------------------------------------------------------------------------- nicotine dependence Phase II (800) 455-1141 Namenda® Forest Laboratories impulse control disorder Phase II memantine New York, NY (compulsive gambling) (800) 947-5227 NanoBUP™ Nanotherapeutics opioid dependence Phase I completed buprenorphine/ Alachua, FL (386) 462-9663 naloxone neboglamine Rottapharm | Madaus cocaine dependence Phase II (CR 2249) Monza, Italy www.rotta.com NIC 002 Novartis Pharmaceuticals nicotine dependence Phase II East Hanover, NJ (888) 669-6682 NicVAX™ GlaxoSmithKline nicotine dependence Phase III nicotine abuse Rsch. Triangle Park, NC (Fast Track) (888) 825-5249 vaccine Nabi Biopharmaceuticals Boca Raton, FL OpRA Eli Lilly alcohol dependence Phase II Indianapolis, IN (800) 545-5979 Probuphine® Titan Pharmaceuticals opioid dependence Phase III bupenorphine South San Francisco, CA (650) 244-4990 Risperdal® Consta® Johnson & Johnson methamphetamine dependence Phase II risperidone Pharmaceutical Research (see also schizophrenia) (800) 817-5286 (injectable) & Development Raritan, NJ SCH 900435 Merck alcohol dependence Phase II Whitehouse Station, NJ (prevention of relapse) (800) 672-6372 (see also schizophrenia) Seroquel XR® AstraZeneca alcohol dependence Phase II completed quetiapine Wilmington, DE (see also anxiety disorders, (800) 236-9933 fumarate depression, personality disorders) extended-release SYN-117 Roche drug dependence Phase I/II Nutley, NJ (see also anxiety disorders) (973) 235-5000 Synosia Therapeutics (650) 244-4850 South San Francisco, CA TA-CD Celtic Pharma cocaine dependence Phase II (cocaine abuse Hamilton, Bermuda www.celticpharma.com vaccine) TO-2060 Transcept Pharmaceuticals alcohol dependence Phase I (olanzepine/ Pt. Richmond, CA (510) 215-3500 ondansetron) Topamax® Johnson & Johnson alcohol dependence Phase II topiramate Pharmaceutical Research (see also anxiety disorders) (800) 817-5286 & Development Raritan, NJ 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 Mental Illnesses 2010 3 A D D I C T I V E D I S O R D E R S Product Name Sponsor Indication Development Status vigabatrin Lundbeck cocaine dependence Phase II Deerfield, IL (Fast Track) (847) 282-1000 -------------------------------------------------------------------------------------- methamphetamine dependence Phase I (847) 282-1000 Vivitrol® Alkermes opioid dependence application submitted naltrexone Cambridge, MA (617) 494-0171 controlled-release A N X I E T Y D I S O R D E R S Product Name Sponsor Indication Development Status 163090 GlaxoSmithKline anxiety Phase I Rsch. Triangle Park, NC (see also depression) (888) 825-5249 356278 GlaxoSmithKline anxiety Phase I Rsch. Triangle Park, NC (see also depression) (888) 825-5249 424887 GlaxoSmithKline anxiety Phase I Rsch. Triangle Park, NC (see also depression) (888) 825-5249 586529 GlaxoSmithKline anxiety Phase I Rsch. Triangle Park, NC (see also depression) (888) 825-5249 Neurocrine Biosciences (858) 617-7600 San Diego, CA 588045 GlaxoSmithKline anxiety Phase I Rsch. Triangle Park, NC (see also depression) (888) 825-5249 ABT-436 Abbott Laboratories anxiety Phase I Abbott Park, IL (see also depression) (847) 937-6100 ADX71149 Johnson & Johnson anxiety Phase I Pharmaceutical Research (see also schizophrenia) (800) 817-5286 & Development Raritan, NJ AVN101 Avineuro Pharmaceuticals
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    U.S. International Trade Commission COMMISSIONERS Daniel R. Pearson, Chairman Shara L. Aranoff, Vice Chairman Jennifer A. Hillman Stephen Koplan Deanna Tanner Okun Charlotte R. Lane Robert A. Rogowsky Director of Operations Karen Laney-Cummings Director of Industries Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States Investigation No. 332--476 Publication 3883 September 2006 This report was prepared principally by Office of Industries Philip Stone, Project Leader With assistance from Elizabeth R. Nesbitt Primary Reviewers David G. Michels, Office of Tariff Affairs and Trde Agreements, John Benedetto, and Nannette Christ, Office of Economics Administrative Support Brenda F. Carroll Under the direction of Dennis Rapkins, Chief Chemicals and Textiles Division ABSTRACT Under the Pharmaceutical Zero-for-Zero Initiative, which entered into force in 1995, the United States and its major trading partners eliminated tariffs on many pharmaceuticals, their derivatives, and certain chemical intermediates used to make pharmaceuticals. The U.S. list of pharmaceutical products and chemical intermediates eligible for duty-free treatment under the agreement is given in the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States. The Pharmaceutical Appendix is periodically updated to provide duty relief for additional such products, including newly developed pharmaceuticals. This report provides advice on the third update to the agreement, in which approximately 1,300 products are proposed to receive duty-free treatment.
  • The Profile of Sabcomeline (SB-202026), a Functionally Selective M1 Receptor Partial Agonist, in the Marmoset

    The Profile of Sabcomeline (SB-202026), a Functionally Selective M1 Receptor Partial Agonist, in the Marmoset

    British Journal of Pharmacology (1998) 124, 409 ± 415 1998 Stockton Press All rights reserved 0007 ± 1188/98 $12.00 http://www.stockton-press.co.uk/bjp The pro®le of sabcomeline (SB-202026), a functionally selective M1 receptor partial agonist, in the marmoset 1M.H. Harries, N.A. Samson, J. Cilia & A.J. Hunter Neurosciences Research, SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Third Avenue, Harlow, Essex, CM19 5AW 71 1 Sabcomeline (SB-202026, 0.03 mg kg , p.o.), a potent and functionally selective M1 receptor partial agonist, caused a statistically signi®cant improvement in the performance of a visual object discrimination task by marmosets. No such improvement was seen after RS86 (0.1 mg kg71, p.o.). 2 Initial learning, which only required an association of object with reward and an appropriate response to be made, was not signi®cantly aected. Reversal learning, which required both the extinction of the previously learned response and the acquisition of a new response strategy, was signi®cantly improved after administration of sabcomeline (0.03 mg kg71, p.o.). 3 Sabcomeline (0.03 and 0.1 mg kg71, p.o.) had no signi®cant eect on mean blood pressure measured for 2 h after administration in the conscious marmoset. 4 Sabcomeline (0.03 mg kg71, p.o.) caused none of the overt eects such as emesis or behaviours often seen after the administration of muscarinic agonists, e.g. face rubbing and licking. 5 This is the ®rst study to demonstrate cognitive enhancement by a functionally selective M1 receptor partial agonist in a normal (i.e.