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2011年在研帕金森病药物 America’s biopharmaceutical research compa- nies are currently developing 36 medicines to help the nearly 1 million Americans suffering from Parkinson’s disease, a motor system disorder resulting from the loss of dopamine- producin...

America’s biopharmaceutical research compa- nies are currently developing 36 medicines to help the nearly 1 million Americans suffering from Parkinson’s disease, a motor system disorder resulting from the loss of dopamine- producing brain cells. All of the medicines are either in clinical trials or awaiting review by the U.S. Food and Drug Administration. Each year, approximately 60,000 Americans are diagnosed with Parkinson’s disease, and incidence increases with age. The combined cost to the U.S. economy in direct and indirect expenses is nearly $25 billion a year, accord- ing to the Parkinson’s Disease Foundation. The medicines today in the research and development pipeline offer hope of reducing the human and economic costs of Parkinson’s disease. They include: � ��*HQH�WKHUDSLHV�WKDW�WDUJHW�VSHFL¿F�DUHDV� in the brain. � ��&HOO�WKHUDS\�WKDW�XVHV�D�SDWLHQW¶V�RZQ� cells to reverse effects of the disease. � ��1HZ�GHOLYHU\�PHFKDQLVPV�RI�FXUUHQWO\� approved treatments, including a transdermal patch and an intranasal formulation. � ��0HGLFLQHV�WR�WUHDW�D�PRWRU�IXQFWLRQ� disorder associated with Parkinson’s disease treatment. Researching and developing new medicines remains a risky investment and lengthy process—costing, on average, $1.2 billion, including the cost of failures, and taking between 10–15 years to bring a new medicine to patients. But advances in our understand- ing of diseases and how to treat them have allowed America’s biopharmaceutical research companies to conduct the cutting-edge research needed to reduce the destructive toll of Parkinson’s disease and to allow more patients to lead healthier, happier, more productive lives. More Than 30 Medicines Are Being Developed to Treat Parkinson’s Disease and Related Conditions Medicines in Development PARKINSON’S DISEASE presented by america’s biopharmaceutical research companies 2011 REPORT Di ag no sis 26 2 13 Re la te d Co nd itio ns Pa rk in so n’ s Di se as e Medicines in Development for Parkinson’s Disease* An estimated 1 million Americans suffer from the disease, with 60,000 newly diagnosed each year * Some medicines are listed in more than one category. Medicines in Development Parkinson’s Disease 20112 Medicines in Development for Parkinson’s Disease )RU�PRUH�LQIRUPDWLRQ�DERXW�D�VSHFL¿F�PHGLFLQH�LQ�WKLV�UHSRUW��SOHDVH�FDOO�WKH�WHOHSKRQH�QXPEHU�OLVWHG� PARKINSON’S DISEASE Product Name Sponsor Indication Development Status* AAD-2004 Amkor Pharma Sammamish, WA 1HXURWHFK�3KDUPDFHXWLFDOV Seoul, South Korea Parkinson’s disease Phase I www.neurotech-pharma.com $$9�$$'&� (gene therapy) *HQ]\PH Cambridge, MA Parkinson’s disease Phase I (617) 252-7500 apomorphine transdermal patch Altea Therapeutics Atlanta, GA Parkinson’s disease Phase I (404) 835-6310 autologous stem cell therapy 1HXUR*HQHUDWLRQ Los Angeles, CA Parkinson’s disease Phase I (310) 659-3880 AZD3241 AstraZeneca Wilmington, DE Parkinson’s disease Phase I (800) 236-9933 &(5(�� $$9�171� &HUHJHQH San Diego, CA Parkinson’s disease Phase II (858) 458-8800 '0�� (levodopa/carbidopa controlled-release) Depomed Menlo Park, CA Parkinson’s disease Phase I completed (650) 462-5900 droxidopa &KHOVHD�7KHUDSHXWLFV Charlotte, NC WUHDWPHQW�RI�IUHH]LQJ�RI�JDLW�LQ� Parkinson’s disease patients (see also related conditions) Phase I/II (704) 341-1516 Duodopa® levodopa/carbidopa intraduodenal gel (Orphan Drug) Abbott Laboratories Abbott Park, IL late-stage Parkinson’s disease (Fast Track) Phase III (847) 937-6100 ¿SDPH]ROH Santhera Pharmaceuticals Charlestown, MA Parkinson’s disease (Fast Track) Phase II completed (617) 886-5161 HT-1067 Helicon Therapeutics San Diego, CA Parkinson’s disease Phase I (858) 246-8120 IPX066 (levodopa/carbidopa extended-release capsules) ,03$;�3KDUPDFHXWLFDOV Hayward, CA early-stage Parkinson’s disease -------------------------------------------------- late-stage Parkinson’s disease Phase III (510) 240-6000 ------------------------------------------- Phase III (510) 240-6000 Medicines in Development Parkinson’s Disease 2011 3 Medicines in Development for Parkinson’s Disease PARKINSON’S DISEASE Product Name Sponsor Indication Development Status istradefylline (KW-6002) Kyowa Hakko Kirin Pharma Princeton, NJ Parkinson’s disease (adjunctive treatment) application submitted (609) 919-1100 Neupro® rotigotine transdermal 8&% Smyrna, GA late-stage Parkinson’s disease application submitted (770) 970-7500 nitisinone �6<1�� Biotie Therapies South San Francisco, CA Parkinson’s disease Phase II (650) 244-4850 1/;�3�� *$'�JHQH�WKHUDS\� 1HXURORJL[ Fort Lee, NJ Parkinson’s disease (Fast Track) Phase II (866) 604-8665 OS-320 Osmotica Pharmaceutical Wilmington, NC Parkinson’s disease Phase II completed (910) 509-0114 Parkinson’s disease gene therapy %LR0HGLFD San Diego, CA 2[IRUG�%LR0HGLFD Oxford, United Kingdom Parkinson’s disease Phase I/II (858) 677-6500 Parkinson’s disease stem cell therapy 6WHPHGLFD�&HOO�7HFKQRORJLHV San Diego, CA Parkinson’s disease in clinical trials (858) 658-0910 preladenant �6&+�� 0HUFN Whitehouse Station, NJ early-stage Parkinson’s disease (Fast Track) (see also related conditions) -------------------------------------------------- late-stage and mid-stage Parkinson’s disease (Fast Track) Phase III (800) 672-6372 ------------------------------------------- Phase III (800) 672-6372 3<0�� Phytopharm Huntingdon, United Kingdom Parkinson’s disease Phase II www.phytopharm.com VD¿QDPLGH (0'�6HURQR Rockland, MA early-stage Parkinson’s disease (see also related conditions) -------------------------------------------------- late-stage and mid-stage Parkinson’s disease Phase III (800) 283-8088 ------------------------------------------- Phase III (800) 672-6372 631�� Supernus Pharmaceuticals Rockville, MD Parkinson’s disease Phase I (301) 838-2500 WR]DGHQDQW �6<1�� Biotie Therapies South San Francisco, CA Parkinson’s disease Phase II (650) 244-4850 Medicines in Development Parkinson’s Disease 20114 PARKINSON’S DISEASE Product Name Sponsor Indication Development Status V1512 Vernalis Winnersh, United Kingdom Parkinson’s disease Phase II www.vernalis.com XP21279 XenoPort Santa Clara, CA Parkinson’s disease Phase II (408) 616-7200 PARKINSON’S DISEASE — DIAGNOSIS Product Name Sponsor Indication Development Status Altropane® molecular imaging agent Alseres Pharmaceuticals Hopkinton, MA Parkinson’s disease (diagnosis) Phase III (508) 497-2360 ÀRUEHWDSLU�)��LQMHFWLRQ Avid Radiopharmaceuticals Philadelphia, PA Parkinson’s disease (diagnosis) Phase II (215) 298-0700 PARKINSON’S DISEASE — RELATED CONDITIONS Product Name Sponsor Indication Development Status ADS-5102 (amantadine controlled-release) Adamas Pharmaceuticals Emeryville, CA levodopa-induced dyskinesia Phase II/III (510) 450-3500 AFQ056 1RYDUWLV�3KDUPDFHXWLFDOV East Hanover, NJ levodopa-induced dyskinesia Phase II (888) 669-6682 AQW051 1RYDUWLV�3KDUPDFHXWLFDOV East Hanover, NJ levodopa-induced dyskinesia Phase II (888) 669-6682 dipraglurant-IR (ADX48621) Addex Pharmaceuticals Geneva, Switzerland levodopa-induced dyskinesia Phase II www.addexpharma.com droxidopa (Orphan Drug) &KHOVHD�7KHUDSHXWLFV Charlotte, NC neurogenic orthostatic hypotension associated with Parkinson’s disease (Fast Track) (see also Parkinson’s disease) Phase III (704) 341-1516 QDOX]RWDQ Proximagen London, United Kingdom levodopa-induced dyskinesia Phase I www.proximagen.com Medicines in Development for Parkinson’s Disease Medicines in Development Parkinson’s Disease 2011 5 PARKINSON’S DISEASE — RELATED CONDITIONS Product Name Sponsor Indication Development Status 1+�� 1HXUR+HDOLQJ�3KDUPDFHXWLFDOV Waban, MA sialorrhea associated with Parkinson’s disease Phase II (617) 331-4111 13�� 1HXUDOWXV�3KDUPDFHXWLFDOV Palo Alto, CA levodopa-induced dyskinesia Phase I/II (650) 424-1600 OP-014 (clonidine/oxybutynin) Orient Pharma Taipei, Taiwan sialorrhea associated with Parkinson’s disease Phase II www.oep.com.tw SLFOR]RWDQ Asubio Pharmaceuticals Paramus, NJ dyskinesia associated with Parkinson’s disease Phase II completed (201) 368-5020 pimavanserin �$&3�� $&$',$�3KDUPDFHXWLFDOV San Diego, CA Parkinson’s disease-associated psychosis Phase III (858) 558-2871 preladenant �6&+�� 0HUFN Whitehouse Station, NJ levodopa-induced dyskinesia (see also Parkinson’s disease) Phase I (800) 672-6372 VD¿QDPLGH (0'�6HURQR Rockland, MA cognitive impairment associated with Parkinson’s disease (see also Parkinson’s disease) -------------------------------------------------- levodopa-induced dyskinesia Phase II (800) 283-8088 ------------------------------------------- Phase II (800) 283-8088 Medicines in Development for Parkinson’s Disease Medicines in Development Parkinson’s Disease 20116 Glossary application submitted—An application for marketing has been submitted by the company to the Food and Drug Administration (FDA). dyskinesia—An impairment in the ability WR�FRQWURO�PRYHPHQWV��FKDUDFWHUL]HG�E\� spasmodic or repetitive motions or lack of coordination. Levodopa is a drug that effec- tively eliminates the major motor symptoms of PD and helps a person move again;; however, levodopa sometimes creates dyskinesia by causing too much movement. Fast Track—A process designed to facilitate the development and expedite the review RI�GUXJV�WR�WUHDW�VHULRXV�GLVHDVHV�DQG�¿OO�DQ� unmet medical need. The status is assigned by the U.S. Food and Drug Administration. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a EURDG�UDQJH�RI�VHULRXV�GLVHDVHV��*HQHUDOO\�� determining factors include whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious RQH��)LOOLQJ�DQ�XQPHW�PHGLFDO�QHHG�LV�GH¿QHG� as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. neurogenic orthostatic hypotention—A drop in blood pressure when changing position from lying to sitting or from sitting to standing, which FDXVHV�OLJKW�KHDGHGQHVV�RU�GL]]LQHVV��,W�LV�D� common symptom of Parkinson’s disease and can make patients pass out and fall. Parkinson’s disease (PD)—PD belongs to a group of conditions called motor system disorders, which are the result of the loss of dopamine-producing brain cells. The four pri- mary symptoms of PD are tremor, or trembling in hands, arms, legs, jaw, and face;; rigidity, or stiffness of the limbs and trunk;; bradykinesia, or slowness of movement;; and postural insta- bility, or impaired balance and coordination. PD is both chronic, meaning it persists over a long period of time, and progressive, meaning its symptoms grow worse over time. As these symptoms become more pronounced, patients PD\�KDYH�GLI¿FXOW\�ZDONLQJ��WDONLQJ��RU�FRPSOHW- ing other simple tasks. Early symptoms of PD are subtle and occur gradually. In some people, the disease progresses more quickly than in others. As the disease progresses, the tremor, which affects the majority of PD patients, may begin to interfere with daily activities. Other symptoms may include depression and other HPRWLRQDO�FKDQJHV��GLI¿FXOW\�LQ�VZDOORZLQJ�� chewing, and speaking;; urinary problems or constipation;; skin problems;; and sleep disrup- tions. Although some people become se- verely disabled, others experience only minor PRWRU�GLVUXSWLRQV��1R�RQH�FDQ�SUHGLFW�ZKLFK� symptoms will affect an individual patient, and the intensity of the symptoms also varies from person to person. Phase 0—First-in-human trials conducted in accordance with FDA’s 2006 guidance on H[SORUDWRU\�,QYHVWLJDWLRQDO�1HZ�'UXJ��,1'�� studies designed to speed up development of promising drugs by establishing very early on whether the agent behaves in human subjects as was anticipated from preclinical studies. Phase I—Safety testing and pharmacological SUR¿OLQJ�LQ�KXPDQV� Phase II—Effectiveness and safety testing in humans. Phase III—Extensive clinical trials to demon- VWUDWH�VDIHW\�DQG�HI¿FDF\�LQ�KXPDQV� sialorrhea—Drooling or excessive salivation, which is a common problem in neurologically impaired children (e.g., those with mental retardation or cerebral palsy) and in adults who have Parkinson’s disease or have had a stroke. It is commonly most caused by poor oral and facial muscle control. The content of this report has been obtained through public, government and industry sources, and the Adis “R&D Insight” database based on the latest information. Report current as of October 24, 2011.�7KH�LQIRUPDWLRQ�LQ�WKLV�UHSRUW�PD\�QRW�EH�FRPSUHKHQVLYH��)RU�PRUH�VSHFL¿F�LQIRUPDWLRQ� about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of 0HGLFLQHV�LQ�'HYHORSPHQW is available on PhRMA’s web site. A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460 www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info 3URYLGHG�DV�D�3XEOLF�6HUYLFH�E\�3K50$��)RXQGHG�LQ��DV�WKH�3KDUPDFHXWLFDO�0DQXIDFWXUHUV�$VVRFLDWLRQ� &RS\ULJKW��E\�WKH�3KDUPDFHXWLFDO�5HVHDUFK�DQG�0DQXIDFWXUHUV�RI�$PHULFD��3HUPLVVLRQ�WR�UHSULQW�LV�DZDUGHG�LI�SURSHU�FUHGLW�LV�JLYHQ� 3KDUPDFHXWLFDO�5HVHDUFK�DQG�0DQXIDFWXUHUV�RI�$PHULFD��)�6WUHHW��1:��:DVKLQJWRQ��'&�� Medicines in Development Parkinson’s Disease 2011 7 Selected Facts about Parkinson’s Disease in the United States The number of people in the United States with Parkinson’s disease is estimated to be as many as 1 million, more than all people diagnosed with multiple sclerosis, muscular dystrophy and amyotrophic lateral sclerosis combined. Approximately 60,000 Americans are newly diagnosed each year.1 As the American population ages, those numbers are expected to grow. Worldwide, the number of people with Parkinson’s disease is expected to double in the next 25 years.2 Parkinson’s disease affects both men and women. The average age of onset of Parkinson’s disease is 61, but it may begin as early as age 40 or even before.2 People as young as 18 have been diag- nosed with Parkinson’s disease.3 Forty percent of people affected by Par- kinson’s disease are under the age of 60, placing them squarely in the workforce. Ex- perts say that about one-third of employed individuals will lose their jobs within a year of a Parkinson’s diagnosis, making lost productivity a major factor in the societal impact of the disease.2 Parkinson’s disease reduces life expec- tancy by an average of three to nine years and is now the 14th leading cause of death in the United States.2 Red haired people have double the risk of developing Parkinson’s Disease. The pigment that colors hair red is made from L-dopa, just as is dopamine, the substance ZKRVH�GH¿FLHQF\�FDXVHV�3DUNLQVRQ¶V� disease.4 Sources: 1. Parkinson’s Disease Foundation (www.pdf.org) �� 7KH�0LFKDHO�6WHUQ�3DUNLQVRQ¶V�5HVHDUFK�)RXQGDWLRQ (www.parkinsoninfo.org) �� 3DUNLQVRQ¶V�$FWLRQ�1HWZRUN�(www.parkinsonsaction.org) 4. Viartis (www.viartis.net) Overview Economic Impact According to the Parkinson’s Action 1HWZRUN��GUXJV�FRPPRQO\�XVHG�WR�WUHDW� Parkinson’s disease cost between $1,000 and $6,000 each year per patient.2 Annual medical care, including doctors’ visits, physical therapies, and treatment for co-occurring illnesses (such as depres- sion), is estimated at $2,000 to $7,000 for people in early stages of the disease, and it is probably much higher for advanced stages.2 Surgical treatments for Parkinson’s dis- ease can cost $25,000 or more.2 As Parkinson’s disease progresses, insti- tutional care at an assisted-living facility or nursing home may be required, and the costs can exceed $100,000 per person annually.2 In the United States, the combined direct and indirect cost of Parkinson’s disease is estimated to be $25 billion per year. This includes treatment costs, Social Security payments, and lost productivity.1 Clinical Trials Discovery/ Preclinical Testing Phase I Phase II Phase III FDA Phase IV Years 6.5 1.5 2 3.5 1.5 Additional post- marketing testing required by FDA Test Population Laboratory and animal studies 20 to 100 healthy volunteers 100 to 500 patient volunteers 1,000 to 5,000 patient volunteers Review process/ approval Purpose Assess safety, biological activity and formulations Determine safety and dosage Evaluate effective- ness, look for side effects Confirm effectiveness, monitor adverse reactions from long-term use Success Rate 5,000 compounds evaluated 5 enter trials 1 approved The U.S. system of new drug approvals is perhaps the most rigorous in the world. It takes 10-15 years, on average, for an experimental drug to travel from lab to U.S. SDWLHQWV��DFFRUGLQJ�WR�WKH�7XIWV�&HQWHU�IRU�WKH� 6WXG\�RI�'UXJ�'HYHORSPHQW��2QO\�¿YH�LQ�� compounds that enter preclinical testing make LW�WR�KXPDQ�WHVWLQJ��$QG�RQO\�RQH�RI�WKRVH�¿YH� is approved for sale. On average, it costs a company $1.2 billion, including the cost of failures, to get one new medicine from the laboratory to U.S. patients, DFFRUGLQJ�

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2011年在研帕金森病药物

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