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Bioasis.ca

Neurologic Disorders
Pharmaceutical Companies Developing 241 Medicines
for Neurologic Disorders

America’s research-based pharmaceutical and 2006 MEDICINES IN DEVELOPMENT FOR NEUROLOGIC DISORDERS*
biotechnology companies are developing 241 new medicines to treat debilitating neurological disorders such as Alzheimer’s, epilepsy, multiple sclerosis, Parkinson’s, and stroke. Combined, the disorders targeted by this research inflict great pain and suffering on patients and their families and every year cost the U.S. economy hundreds of billions of dollars in care, lost work days, and reduced productivity. The economic cost of Alzheimer’s alone, for example, totals at least $100 billion annually.
The medicines in development (either in human clinical trials or at the Food and Drug Administration *Some medicines are listed in more than one category.
• 62 medicines for pain, the most common reason Americans seek medical care, with 57 percent of U.S.
• A medicine for glioblastoma (brain cancer) that singles adults having experienced chronic or recurrent pain in out and latches onto the receptors on the surface of the malignant cells—but not the healthy cells—and • 34 medicines for brain tumors, with an estimated 359,000 Americans having a primary brain tumor.
• A medicine for Alzheimer’s that both inhibits plaque • 42 medicines for Alzheimer’s disease, which afflicts formation and blocks the degradation of the about 4.5 million Americans, including 1 in 10 people over 65 and nearly half of those over 85.
The new medicines now in the research pipeline will • 21 medicines for Parkinson’s disease, which affects as add to the substantial progress made in the last five years by pharmaceutical and biotechnology companies in • 13 medicines for stroke, the third leading cause of developing new and more effective neurologic treatments.
death after heart disease and cancer.
They are giving patients and health-care providers new • 11 medicines for migraine, a condition that affects hope that more effective treatments and even possible about 28 million people or 13 percent of the U.S.
cures may soon be available. This strong commitment to research—building on the past, continuing in the present, • 27 medicines for multiple sclerosis, which afflicts some and heading into the future—is a product of the determination of the men and women working for • 13 medicines for epilepsy; more than 2 million America’s research-based pharmaceutical companies to Americans have experienced an unprovoked seizure or develop new medicines to help patients live longer, have been diagnosed with the disease.
healthier, and more productive lives.
Other medicines in development target brain injuries, Huntington’s disease, spinal cord injury, myasthenia gravis, juvenile cerebral palsy, and restless legs syndrome.
The many promising new medicines in development • A medicine that uses normal human cells to enhance brain levels of dopamine, the neurotransmitter deficient Medicines in Development for
Neurologic Disorders

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

Indication
Development Status*
Agilect®
Alzhemed
Ampalex®
Aricept®
-------------------------------------------------------------------------------------- Avandia®
* For more information about a specific medicine in this report, please call the telephone number listed.
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

Indication
Development Status*
Exelon® TDS
Flurizan
Inflazyme Pharmaceuticals age-associated memory Vancouver, British Columbia impairment Memryte
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

Indication
Development Status*
Risperdal®
Tanakan®
A M Y O T R O P H I C L A T E R A L S C L E R O S I S ( A L S )
Product Name

Indication
Development Status
Myogane
B R A I N T U M O R S
Product Name

Indication
Development Status
(Orphan Drug)
B R A I N T U M O R S
Product Name

Indication
Development Status
-------------------------------------------------------------------------------------- Efaproxyn
-------------------------------------------------------------------------------------- Eloxatin
-------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------- fenretinide (4-HPR) National Cancer Institute B R A I N T U M O R S
Product Name

Indication
Development Status
Hycamtin
-------------------------------------------------------------------------------------- (Orphan Drug)
Iressa®
-------------------------------------------------------------------------------------- O-6-benzylguanine National Cancer Institute -------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------- B R A I N T U M O R S
Product Name

Indication
Development Status
Revlimid
Tarceva
Trisenox
Xerecept®
Neurobiological Technologies peritumoral brain edema -------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------- Zarnestra
-------------------------------------------------------------------------------------- E P I L E P S Y
Product Name
Indication
Development Status
E P I L E P S Y
Product Name
Indication
Development Status
(see also migraine, multiple sclerosis, (888) 274-2378 Lamictal® XR
(Orphan Drug)
-------------------------------------------------------------------------------------- H U N T I N G T O N ’ S D I S E A S E
Product Name
Indication
Development Status
(Orphan Drug)
Miraxion
M I G R A I N E
Product Name
Indication
Development Status
Aricept®
Frova
Trexima
M U L T I P L E S C L E R O S I S
Product Name

Indication
Development Status
integrin antagonist) Rsch. Triangle Park, NC M U L T I P L E S C L E R O S I S
Product Name

Indication
Development Status
Campath®
Copaxone®
Millennium Pharmaceuticals multiple sclerosis Millennium Pharmaceuticals multiple sclerosis NeuroVax
M U L T I P L E S C L E R O S I S
Product Name

Indication
Development Status
Rituxan®
-------------------------------------------------------------------------------------- Tauferon
Tovaxin
P A I N
Product Name

Indication
Development Status
Accelanyl
P A I N
Product Name

Indication
Development Status
Arcoxia
Cellegesic
Chronogesic®
Dyloject
Dynastat
Dysport®
Gabapentin GR
P A I N
Product Name

Indication
Development Status
Lidoderm®
lidocaine patch 5% Chadds Ford, PA LidoPAIN® BP
Namenda
Neurodex
OraVescent®
OxyNal
OxyQD
Oxytrex
PMI-150
P A I N
Product Name

Indication
Development Status
Prexige®
dopamine re-uptake Rsch. Triangle Park, NC Rapinyl
fentanyl (sublingual) Chadds Ford, PA Remoxy
Rylomine
Vicodin CR
P A R K I N S O N ’ S D I S E A S E
Product Name
Indication
Development Status
receptor antagonist Kenilworth, NJ Agilect®
Altropane®
ReQuip®
acute symptoms of Parkinson’s disease Phase I Spheramine
(Orphan Drug)
P A R K I N S O N ’ S D I S E A S E
Product Name
Indication
Development Status
Zelapar
R E S T L E S S L E G S S Y N D R O M E
Product Name
Indication
Development Status
ReQuip®
(gabapentin prodrug) Santa Clara, CA S L E E P D I S O R D E R S
Product Name

Indication
Development Status
Gaboxadol
Nuvigil
S P I N A L C O R D I N J U R Y
Product Name

Indication
Development Status
Cethrin®
S T R O K E
Product Name

Indication
Development Status
Cerebril
Actelion Pharmaceuticals US prevention of vasospasm following S T R O K E
Product Name

Indication
Development Status
Viprinex
O T H E R
Product Name

Indication
Development Status
Ampalex®
Avonex®
CellCept
Dysport®
Neurodex
NeuroSTAT
O T H E R
Product Name

Indication
Development Status
Rituxan®
chemotherapy-induced neuropathies Phase III (R-baclofen prodrug) Santa Clara, CA The content of this survey has been obtained through government sources, industry sources, and the “Adis R&D Insight” database based on the latest information. Survey current as of February 28, 2006. The information may not be
comprehensive. For more specific information about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site.
A publication from PhRMA Communications. (202) 835-3460
www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
Copyright 2006 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded G L O S S A R Y
Alzheimer’s disease—Progressive and
glioblastoma multiforme—The most
myasthenia gravis—A chronic auto-
rarely reversible chronic deterioration of astrocytomas. The tumor grows so fast that
amyotrophic lateral sclerosis (ALS)
Also known as Lou Gehrig’s disease, the ducing headaches, slowed thinking, and if glioma—A type of brain tumor arising
that increases during periods of activity from the supporting glial cells within the narcolepsy—Chronic, excessive daytime
percent of all primary brain tumors.
Huntington’s disease—Huntington’s
recurring several times a day, which last application submitted—An application
from a few seconds to about 15 minutes.
neuroblastoma—A tumor of the adrenal
astrocytoma—A type of malignant brain
tions, such as the control of heart rate).
mon type of glioma, a tumor arising
Lennox-Gastaut syndrome—Char-
dation in infants and young children.
cerebral amyloid angiopathy (CAA)
medulloblastoma—The most common
neurofibromatosis—The neurofibro-
protein deposit (amyloid) in the walls of neuropathies—Abnormal and usually
bleeding (or hemorrhagic) stroke.
meningioma—A type of tumor that
cerebral palsy—A general term for
atrophy, that stem from neuropathies.
Parkinson’s disease—Chronic
cervical dystonia—Disorder or lack of
characterized by tremors, rigidity and an the word “benign” can be misleading in dementia—Degeneration of central
Phase I—Safety testing and pharma-
learning capacity. The natural decline of Phase II—Effectiveness testing in humans.
Phase III—Extensive clinical trials in humans.
metastases/metastatic—Areas of
post-herpetic neuralgia—A burning pain that
epilepsy—Recurrent seizures—transient
may recur at the site of an attack of shingles the primary or original cancer site.
months or even years after the illness.
abnormal electrical activity in the brain migraine headache—Severe headache
restless legs syndrome—Restless legs
—or temporary alteration in one or more blood vessels deep within the brain. It can the legs usually caused by uncomfortable or last from two hours to several days and is spinal cord injury—Damage to the
Friedreich’s ataxia—An inherited
and sensitivity to noise and/or light.
multiple sclerosis (MS)—Progressive
sensation, muscle weakness or paralysis.
stroke—Usually caused by athero-
sclerosis. It results in death or serious of nerve fibers (myelin) in the brain and “Ataxia,” which refers to coordination of speech. An ischemic stroke is caused
S E L E C T E D F A C T S A B O U T N E U R O L O G I C
D I S O R D E R S I N T H E U N I T E D S T A T E S

Alzheimer’s Disease/Dementias1
• Some 4.5 million Americans have Alzheimer’s disease (AD). By 2050, the estimated range of AD prevalence will
be 11.3 million to 16 million Americans, unless a cure or prevention is found.
• U.S. society spends at least $100 billion a year on AD.
Brain Tumors2
• In 2004, an estimated 40,900 new cases of primary brain tumors (both malignant and benign) were diagnosed. • Approximately 3,140 American children (younger than age 20) are diagnosed annually with primary brain tumors, which are the most common form of solid tumors in children and the second most frequent malignancy of childhood. Brain tumors are the second leading cause of cancer-related deaths in children.
Epilepsy3
• More than 2 million people in the United States—about 1 in 100—have experienced an unprovoked seizure or have been diagnosed with epilepsy. For about 80 percent of those people, seizures can be controlled with modern medicines and surgery, but about 20 percent of them have intractable epilepsy. • About 20 percent of seizures in children are due to cerebral palsy or other neurological abnormalities.
Head Injury4
• Each year, 1.5 million Americans sustain a traumatic brain injury (TBI)—that’s one person injured every 21 seconds. The risk of TBI is highest among adolescents, young adults and those older than age 75. More than 50,000 people die each year as a result of brain injury.
• The direct medical costs and indirect costs of TBI totaled an estimated $56.3 billion in 1995.
Huntington’s Disease3
• About 30,000 people in the United States have Huntington’s disease (HD). Its estimated prevalence is about 1 in every 10,000 people. Today, at least 150,000 people have a 50 percent risk of developing HD, and thousands more of their relatives live with the possibility that they, too, might develop HD.
Migraine5
• Approximately 28 million people—about 13 percent of the U.S. population—suffer from migraines. While migraines afflict both men and women, three times more women than men experience them. • An estimated 157 million workdays are lost annually because of the pain and associated symptoms of migraine, which costs U.S. employers $13 billion a year in missed work and reduced productivity.
Multiple Sclerosis6
• Some 400,000 Americans have multiple sclerosis (MS), and every week another 200 are diagnosed. Up to three times as many women as men have MS. Most people are diagnosed between the ages of 20 and 50. Neuropathies
• People with diabetes can develop nerve problems at any time, but significant clinical neuropathy can develop
within the first 10 years after diagnosis. Some 60 percent of patients have some form of neuropathy, but in 30 percent to 40 percent of cases there are no symptoms.7
Peripheral neuropathy affects at least 20 million people in this country8
• The majority of U.S. adults—57 percent—have experienced chronic or recurrent pain in the past year.
• Pain costs an estimated $100 billion each year. In 1996, more than $50 billion was spent on the diagnosis and treatment of back pain alone.
S E L E C T E D F A C T S A B O U T N E U R O L O G I C
D I S O R D E R S I N T H E U N I T E D S T A T E S

Parkinson’s Disease
• Today, 1.5 million Americans have PD, and each year 60,000 new cases are diagnosed.9 A new case of
Parkinson’s is diagnosed in this country every nine minutes.10
• PD is estimated to cost the nation about $25 billion annually.11
Sleep Disorders12
Insomnia affects more than 70 million Americans. Chronic or severe insomnia affects up to 15 percent of adults.
• Some 12 million Americans experience restless legs syndrome, which increases with age. Older people
experience symptoms more frequently and for longer periods of time.
• Sleep deprivation and sleep disorders are estimated to cost Americans more than $100 billion annually in lost
productivity, medical expenses, sick leave, and property and environmental damage.
Spinal Cord Injury13
• The estimated annual incidence of spinal cord injury (SCI), not including those who die at an accident scene, is approximately 11,000 new cases each year in the United States. The estimated number of people living today with SCI ranges from 225,000 to 288,000.
• The costs for those living with SCI vary greatly according to injury severity. For example, the lifetime direct medical costs are more than $2 million for someone with high quadriplegia injured at age 25, compared with the more than $600,000 it will cost someone injured at the same age who has incomplete motor functions.
Stroke14
• About 700,000 Americans will have a stroke this year—that’s someone every 45 seconds. In adults over age 55, the lifetime risk for stroke is greater than 1 in 6.
• Stroke accounted for more than 1 of every 15 deaths in the United States in 2002. On average, every three • The direct and indirect costs of stroke are estimated to be $56.8 billion in 2005.
• More than 4,500 American infants are diagnosed each year with cerebral palsy. Birth complications account for
probably less than 10 percent of these cases. About 10 percent to 20 percent of American children acquire the disorder after birth as a result of brain infections or injuries.3
Sources:
1. Alzheimer’s Association (www.alz.org) 2. American Brain Tumor Association (www.abta.org)3. National Institute of Neurological Disorders and Stroke (www.ninds.nih.gov)4. Brain Injury Association of America (www.biausa.org)5. National Headache Foundation (www.headaches.org)6. National Multiple Sclerosis Society (www.nationalmssociety.org)7. American Pain Foundation (www.painfoundation.org)8. neurologychannel (www.neurologychannel.com)9. National Parkinson Foundation (www.parkinson.org) 10. St. Mary’s Health Care (www.smmmc.org) 11. Parkinson’s Action Network (www.parkinsonsaction.org) 12. National Sleep Foundation (www.sleepfoundation.org)13. Spinal Cord Injury Information Network (www.spinalcord.uab.edu)14. American Heart Association (www.americanheart.org) D I S C O V E R Y ,
D E V E L O P M E N T
A P P R O V A L
It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients.
Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
Clinical Trials
Discovery/
Preclinical Testing
Population
T H E D R U G D E V E L O P M E N T A N D A P P R O V A L P R O C E S S
The U.S. system of new drug approvals is perhaps Clinical Trials, Phase I. These tests involve about
20 to 100 normal, healthy volunteers. The tests study adrug’s safety profile, including the safe dosage range.
It takes 10–15 years, on average, for an experimental The studies also determine how a drug is absorbed, drug to travel from lab to U.S. patients, according to distributed, metabolized, and excreted as well as the the Tufts Center for the Study of Drug Development, based on drugs approved from 1994 through 1998.
Only five in 5,000 compounds that enter preclinical Clinical Trials, Phase II. In this phase, controlled
testing make it to human testing. And only one of those trials of approximately 100 to 500 volunteer patients (people with the disease) assess a drug’s effectiveness. On average, it costs a company $802 million to Clinical Trials, Phase III. This phase usually involves
get one new medicine from the laboratory to U.S.
1,000 to 5,000 patients in clinics and hospitals.
patients, according to a November 2001 report by the Physicians monitor patients closely to confirm efficacy Tufts Center for the Study of Drug Development.
Once a new compound has been identified in the New Drug Application (NDA)/Biologic License
laboratory, medicines are developed as follows: Application (BLA). Following the completion of all
three phases of clinical trials, a company analyzes all
Preclinical Testing. A pharmaceutical company
of the data and files an NDA or BLA with FDA if the conducts laboratory and animal studies to show data successfully demonstrate both safety and biological activity of the compound against the effectiveness. The applications contain all of the targeted disease, and the compound is evaluated for scientific information that the company has gathered.
Applications typically run 100,000 pages or more.
Investigational New Drug Application (IND). After
The average review time for the 36 new therapeutics completing preclinical testing, a company files an IND approved by the FDA in 2004 was 18.1 months.
with the U.S. Food and Drug Administration (FDA) to Approval. Once FDA approves an NDA or BLA, the
begin to test the drug in people. The IND becomes new medicine becomes available for physicians to effective if FDA does not disapprove it within 30 days.
prescribe. A company must continue to submit The IND shows results of previous experiments; how, periodic reports to FDA, including any cases of where and by whom the new studies will be adverse reactions and appropriate quality-control conducted; the chemical structure of the compound; records. For some medicines, FDA requires additional how it is thought to work in the body; any toxic trials (Phase IV) to evaluate long-term effects.
effects found in the animal studies; and how thecompound is manufactured. All clinical trials must be Discovering and developing safe and effective new reviewed and approved by the Institutional Review medicines is a long, difficult, and expensive process.
Board (IRB) where the trials will be conducted.
PhRMA member companies invested an estimated Progress reports on clinical trials must be submitted at $39.4 billion in research and development in 2005.
Medicines in Development for Neurologic Disorders is presented by PhRMA in cooperation with the following Huntington’s Disease Society of America Interamerican College of Physicians & Surgeons MAGNUM, The National Migraine Association Michael J. Fox Foundation for Parkinson’s Research National Chronic Pain Outreach Association United Cerebral Palsy Research and Educational Foundation Being listed in this report in no way implies that the above-mentioned organizations endorse or recommend the use of any of the products in development contained in this publication. For further information, patients should consult their physicians or health care providers.
Pharmaceutical Research and Manufacturers of America www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info

Source: http://www.bioasis.ca/pdfs/Neurologic_2006.pdf

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