PhRMA Report 2012: Medicines in Development for Alzheimers
1. 2012 Report
Medicines in Development
Alzheimer’s Disease
presented by america’s biopharmaceutical
research companies
Biopharmaceutical Research Companies are
Developing Nearly 100 Medicines for Alzheimer’s
Disease and Other Dementias
Medicines in Development
For Alzheimer’s Disease*
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Today, more than 5 million Americans are suf- human clinical trials or awaiting U.S. Food and
fering from Alzheimer’s disease. The disease Drug Administration (FDA) review. They are
ravages the minds of patients, crushes entire exploring various new approaches to treating
families and currently costs the health care Alzheimer’s disease, including:
system $200 billion a year. These sobering • medicine that inhibits the formation and
A
statistics are projected to get much worse as accumulation of amyloid-beta and tau
the 76 million American baby boomers age. protein deposits.
If no new medicines are found to prevent, • n intranasal medicine that is able to
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delay or stop the progression of Alzheimer’s penetrate the blood-brain barrier for mild
disease, the number of people affected in cognitive impairment, a precursor to
America will jump to 13.5 million by 2050, Alzheimer’s.
according to the Alzheimer’s Association.
Costs for care for Alzheimer’s patients will • A gene therapy for the treatment of
increase five-fold to $1.08 trillion a year. Alzheimer’s disease.
Even modest progress can drastically change The quest is intense and financially risky. It
this trajectory. A breakthrough medicine that takes, on average, more than $1 billion and
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delays the onset of Alzheimer’s disease by 10 to 15 years to develop a new medicine. But
just five years could decrease the number of new scientific advances are increasing our
5
Americans suffering from the disease in 2050 knowledge, and researchers are using every
2
by 43 percent and the related costs of care by cutting-edge tool at their disposal. With contin-
$447 billion. Hope for the future lies in medical ued dedication, we hope to make a difference
for every person at risk of suffering from this
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rently have 93 medicines in development for
* Some medicines are in development Alzheimer’s disease and dementias—either in
for more than one disorder.
2. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status*
AAB-002 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase 0
(amyloid beta-protein inhibitor South San Francisco, CA (888) 381-4595
mAb) Pfizer (800) 879-3477
New York, NY
AAB-003/PF-05236812 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase I
(amyloid beta-protein inhibitor South San Francisco, CA (888) 381-4595
mAb) Pfizer (800) 879-3477
New York, NY
ABT-126 Abbott Laboratories mild to moderate Alzheimer’s disease Phase II
(alpha-7 neuronal nicotinic Abbott Park, IL (847) 937-6100
receptor antagonist) -------------------------------------------------- -------------------------------------------
Alzheimer’s disease Phase I
(combination therapy), (847) 937-6100
Alzheimer’s disease (elderly)
ABT-288 Abbott Laboratories Alzheimer’s disease Phase II
(neurotransmitter receptor Abbott Park, IL (847) 937-6100
modulator)
ABT-384 Abbott Laboratories mild to moderate Alzheimer’s disease Phase II
Abbott Park, IL (847) 937-6100
ABT-560 Abbott Laboratories cognitive disorders Phase I
(alpha-4 beta-2 nicotinic Abbott Park, IL (847) 937-6100
receptor modulators)
ABT-957 Abbott Laboratories Alzheimer’s disease Phase I
(calpain inhibitor) Abbott Park, IL (847) 937-6100
ACC-002 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase 0
(amyloid-beta peptide South San Francisco, CA (888) 381-4595
conjugate) Pfizer (800) 879-3477
New York, NY
AD02 vaccine Affiris Alzheimer’s disease Phase II
Vienna, Austria (888) 825-5249
GlaxoSmithKline
Rsch. Triangle Park, NC
AD03 vaccine Affiris Alzheimer’s disease Phase I
Vienna, Austria (888) 825-5249
GlaxoSmithKline
Rsch. Triangle Park, NC
*For more information about a specific medicine in this report, please call the telephone number listed.
2 Medicines in Development Alzheimer’s Disease 2012
3. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status
ADS-8704 Adamas Pharmaceuticals moderate to severe Alzheimer’s Phase II
(donepezil/memantine) Emeryville, CA disease (510) 450-3500
APH-0703 Aphios Alzheimer’s disease, Phase I/II
Woburn, MA cognitive disorders (781) 932-6933
ARC029 Archer Pharmaceuticals mild to moderate Alzheimer’s disease Phase I
(soluble amyloid Sarasota, FL (941) 755-6644
reducing/clearing agent)
(Orphan Drug)
ARC031 Archer Pharmaceuticals Alzheimer’s disease Phase I
(soluble amyloid Sarasota, FL (941) 755-6644
reducing/clearing agent)
ASP0777 Astellas Pharma US dementia associated with Alzheimer’s Phase I
Deerfield, IL disease (800) 695-4321
AVN 101 Avineuro Pharmaceuticals cognitive enhancer in Alzheimer’s Phase II
(serotonin 6 receptor San Diego, CA disease (858) 436-1537
antagonist)
AVN 322 Avineuro Pharmaceuticals Alzheimer’s disease Phase I
(serotonin 6 receptor San Diego, CA (858) 436-1537
antagonist)
AVN 397 Avineuro Pharmaceuticals Alzheimer’s disease Phase II
San Diego, CA (858) 436-1537
AZD1446 AstraZeneca Alzheimer’s disease Phase I
(alpha4/beta2 neuronal Wilmington, DE (800) 236-9933
nicotinic receptor agonist) Targacept (336) 480-2100
Winston-Salem, NC
AZD3480 AstraZeneca Alzheimer’s disease Phase II
(ispronicline) Wilmington, DE (800) 236-9933
Targacept
Winston-Salem, NC
AZD4694 Navidea Biopharmaceuticals Alzheimer’s disease (diagnosis) Phase II
(fluorine-18 labeled precision Dublin, OH (614) 793-7500
radiopharmaceutical)
AZD5213 AstraZeneca Alzheimer’s disease Phase II
(histamine-3 receptor Wilmington, DE (800) 236-9933
antagonist)
Medicines in Development Alzheimer’s Disease 2012 3
4. Medicines in Development for Alzheimer’s Disease
ALZHEIMER’S DISEASE AND DEMENTIAS
Product Name Sponsor Indication Development Status
ß secretase inhibitor Eli Lilly Alzheimer’s disease Phase II
Indianapolis, IN (800) 545-5979
BAN2401 BioArtic Neuroscience mild to moderate Alzheimer’s disease Phase I
(amyloid beta-protein inhibitor) Stockholm, Sweden www.bioarti.se
Eisai (888) 274-2378
Woodcliff Lake, NJ
bapineuzumab subcutaneous Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase II
(AAB-001) South San Francisco, CA (subcutaneous) (888) 381-4595
Pfizer (800) 879-3477
New York, NY
BCI-632 BrainCells Alzheimer’s disease Phase I
San Diego, CA (858) 812-7700
BCI-838 BrainCells Alzheimer’s disease Phase I
San Diego, CA (858) 812-7700
BIIB037 Biogen Idec Alzheimer’s disease Phase I
(amyloid beta-protein inhibitor) Cambridge, MA (617) 679-2000
bisnorcymserine QR Pharma Alzheimer’s disease Phase I
(BNC) Berwyn, PA (610) 727-3913
BMS-241027 Bristol-Myers Squibb Alzheimer’s disease, tauopathies Phase I
(microtubule stabilizer) Princeton, NJ (800) 332-2056
BMS-708163 Bristol-Myers Squibb Alzheimer’s disease Phase II
(avagacestat) Princeton, NJ (800) 332-2056
BMS-932481 Bristol-Myers Squibb Alzheimer’s disease Phase I
(gamma secretase modulator) Princeton, NJ (800) 332-2056
BMS-933043 Bristol-Myers Squibb cognitive impairment Phase I
(a-7 nicotinic agonist) Princeton, NJ (800) 332-2056
CAD106 Novartis Pharmaceuticals Alzheimer’s disease Phase II
(amyloid beta-protein inhibitor) East Hanover, NJ (888) 669-6682
CERE-110 Ceregene Alzheimer’s disease Phase II
(AAV-NGF gene therapy) San Diego, CA (858) 458-8800
CHF-5074 Chiesi Pharmaceuticals mild cognitive impairment Phase II
(amyloid precursor protein Rockville, MD (301) 424-2661
secretase modulator)
4 Medicines in Development Alzheimer’s Disease 2012
5. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status
crenezumab Genentech Alzheimer’s disease Phase II
(anti-Abeta) South San Francisco, CA (800) 626-3553
CTS-21166 Astellas Pharma US Alzheimer’s disease Phase I
(ß-secretase inhibitor) Deerfield, IL (800) 695-4321
CoMentis (650) 359-2600
South San Francisco, CA
CX717 Cortex Pharmaceuticals Alzheimer’s disease Phase II completed
Irvine, CA (949) 727-3157
davunetide intranasal Allon Therapeutics Alzheimer’s disease, mild cognitive Phase II
Vancouver, Canada impairment (604) 736-0634
docosahexaenoic acid Martek Biosciences Alzheimer’s disease Phase III
(DHA) Parsippany, NJ (973) 257-8011
DSP-8658 Sunovion Pharmaceuticals Alzheimer’s disease Phase I
(PPAR a/g agonist) Marlborough, MA (508) 481-6700
E2212 Eisai Alzheimer’s disease Phase I
(amyloid precursor protein Woodcliff Lake, NJ (888) 274-2378
secretase modulator)
E2609 Eisai Alzheimer’s disease Phase I
(BACE1 protein inhibitor) Woodcliff Lake, NJ (888) 274-2378
ELND005 Elan mild to moderate Alzheimer’s disease Phase II
(amyloid beta-protein inhibitor) South San Francisco, CA (Fast Track) (650) 877-0900
Transition Therapeutics (416) 260-7770
Toronto, Canada
EVP-0962 EnVivo Pharmaceuticals Alzheimer’s disease Phase I
(amyloid precursor protein Watertown, MA (617) 225-4250
secretase modulator)
EVP-6124 EnVivo Pharmaceuticals mild to moderate Alzheimer’s disease Phase II
(α7-nAChR agonist) Watertown, MA (617) 225-4250
Exebryl-1® ProteoTech Alzheimer’s disease Phase I
Kirkland, WA (425) 823-0400
F18-florbetaben Piramal Healthcare Alzheimer’s disease (diagnosis) Phase III
(molecular imaging agent) Mumbai, India www.piramalhealthcare.com
F18-flutemetamol GE Healthcare Alzheimer’s disease (diagnosis) Phase III
(PET imaging agent) Waukesha, WI www.gehealthcare.com
Medicines in Development Alzheimer’s Disease 2012 5
6. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status
Gammagard® Baxter Healthcare early-stage Alzheimer’s disease, Phase III
immune globulin intravenous Deerfield, IL mid-stage Alzheimer’s disease (800) 422-9837
(human), 10% solution
gantenerumab Roche prodromal Alzheimer’s disease Phase II/III
(RG1450) Nutley, NJ (973) 235-5000
GSK239512 GlaxoSmithKline Alzheimer’s disease Phase II completed
Rsch. Triangle Park, NC (888) 825-5249
GSK742457 GlaxoSmithKline Alzheimer’s disease Phase II completed
(5HT6 antagonist) Rsch. Triangle Park, NC (888) 825-5249
GSK933776A GlaxoSmithKline Alzheimer’s disease Phase I completed
(anti-B amyloid mAb) Rsch. Triangle Park, NC (888) 825-5249
HPP-854 High Point Pharmaceuticals Alzheimer’s disease Phase I
(BACE1 inhibitor) High Point, NC (336) 841-0300
human immunoglobulin Grifols USA Alzheimer’s disease Phase III
(intravenous) Los Angeles, CA (888) 474-3657
immune globulin high dose Octapharma USA Alzheimer’s disease (elderly) Phase II completed
Hoboken, NJ (201) 604-1130
irdabisant Cephalon cognitive dysfunction associated with Phase I
(CEP-26401) Frazer, PA Alzheimer’s disease (610) 344-0200
LMTX TauRx Pharmaceuticals mild to moderate Alzheimer’s disease Phase I
(TRx-0237) Singapore www.taurx.com
LNK-754 Link Medicine mild Alzheimer’s disease Phase I completed
Waltham, MA (781) 577-6700
LU AE58054 Lundbeck Alzheimer’s disease Phase II
Deerfield, IL (800) 455-1141
MCD-386/glycopyrrolate Mithridion autosomal dominant Alzheimer’s Phase I
Madison, WI disease www.mithridion.com
MK-3134 Merck dementia Phase I completed
Whitehouse Station, NJ (800) 672-6372
MK-3328 Merck Alzheimer’s disease (diagnosis) Phase I completed
(PET tracer) Whitehouse Station, NJ (800) 672-6372
MK-8931 Merck Alzheimer’s disease Phase I
(BACE1 inhibitor) Whitehouse Station, NJ (800) 672-6372
6 Medicines in Development Alzheimer’s Disease 2012
7. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status
MSDC-0160 Metabolic Solutions Development Alzheimer’s disease Phase II
Company (269) 343-6732
Kalamazoo, MI
NIC5-15 Humanetics Alzheimer’s disease Phase II
Minneapolis, MN (952) 937-7660
PF-05212377 Pfizer Alzheimer’s disease Phase I
(SAM-760) New York, NY (800) 879-3477
pioglitazone Takeda Pharmaceuticals U.S.A. Alzheimer’s disease (diagnosis) Phase I
companion Deerfield, IL (877) 825-3327
diagnostic Zinfadel Pharmaceuticals
Chapel Hill, NC
Posiphen™ QR Pharma Alzheimer’s disease, Phase II
R-phenserine Berwyn, PA mild cognitive impairment (610) 727-3913
PRX-3140 Nanotherapeutics Alzheimer’s disease Phase II
(5-HT4 partial agonist) Alachua, FL (386) 462-9663
RG1577 Roche Alzheimer’s disease Phase II
(MAO-B inhibitor) Nutley, NJ (973) 235-5000
RG1662 Roche cognitive disorders Phase I
(GABAA a5 receptor modulator) Nutley, NJ (973) 235-5000
RG7129 Roche Alzheimer’s disease Phase I
(BACE1 protein inhibitor) Nutley, NJ (973) 235-5000
rilapladib GlaxoSmithKline Alzheimer’s disease Phase II
Rsch. Triangle Park, NC (888) 825-5249
Human Genome Sciences (301) 309-8504
Rockville, MD
RVX-208 Resverlogix Alzheimer’s disease Phase I
(BET protein inhibitor) Calgary, Canada (403) 254-9252
SAR110894 Sanofi US Alzheimer’s disease Phase II
(H3 antagonist) Bridgewater, NJ (800) 981-2491
SAR228810 Sanofi US Alzheimer’s disease Phase I
Bridgewater, NJ (800) 981-2491
sGC-1061 sGC Pharma Alzheimer’s disease Phase I
Wellesley, MA (613) 791-4464
Medicines in Development Alzheimer’s Disease 2012 7
8. Medicines in Development for Alzheimer’s Disease
Alzheimer’s Disease and Dementias
Product Name Sponsor Indication Development Status
solanezumab Eli Lilly Alzheimer’s disease Phase III
Indianapolis, IN (800) 545-5979
ST-101 Sonexa Therapeutics Alzheimer’s disease Phase II
San Diego, CA (858) 356-6250
SYN-120 Biotie Therapies cognitive disorders associated with Phase I completed
South San Francisco, CA Alzheimer’s disease (650) 244-4850
T-817MA Toyama Chemical mild to moderate Alzheimer’s disease Phase II completed
Tokyo, Japan www.toyama-chemical.co.jp
TC-5619 Targacept Alzheimer’s disease Phase I
Winston-Salem, NC (336) 480-2100
TD-8954 Theravance cognitive impairment associated with Phase I
(5-HT4 agonist) South San Francisco, CA Alzheimer’s disease (877) 275-8479
TTP-448 TransTech Pharma Alzheimer’s disease Phase II
(RAGE antagonist) High Point, NC (336) 841-0300
UB-311 United Biomedical mild to moderate Alzheimer’s disease Phase I
(amyloid beta protein inhibitor Hauppauge, NY (631) 273-2828
vaccine)
V950 Merck Alzheimer’s disease Phase I
vaccine Whitehouse Station, NJ (800) 672-6372
vanutide cridificar Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase II
(ACC-001) South San Francisco, CA (888) 381-4595
Pfizer (800) 879-3477
New York, NY
velusetrag Theravance Alzheimer’s disease Phase I
(TD-5108) South San Francisco, CA (877) 275-8479
VI-1121 VIVUS Alzheimer’s disease Phase II
Mountain View, CA (650) 934-5200
XEL 001HP Xel Pharmaceuticals Alzheimer’s disease Phase I
(transdermal patch) Draper, UT (866) 832-7546
8 Medicines in Development Alzheimer’s Disease 2012
9. Glossary
Alzheimer’s disease—The most common review of drugs to treat serious diseases and delusions, and paranoia, and may behave
form of dementia, characterized by progressive fill an unmet medical need. The purpose is to impulsively.
and chronic deterioration of cognitive functions, get new drugs for serious diseases to patients
including memory, thinking and reasoning. earlier and must be requested by the biophar- PET imaging—Positron emission tomography
Early manifestations include forgetfulness, maceutical company. Fast Track addresses a (PET), a noninvasive medical imaging tech-
impaired ability to focus, and changes in mood broad range of serious diseases. Generally, nique that utilizes a radioactive agent (“tracer”)
and personality. As the disease progresses, determining factors include whether the drug incorporated in a biologically active molecule
there is a loss of computational ability, in addi- will have an impact on such factors as survival, and a scanner to produce three-dimensional
tion to word-finding problems and difficulty with day-to-day functioning, or the likelihood that images of the body.
ordinary activities. Ultimately, the disease leads the disease, if left untreated, will progress Phase 0—First-in-human trials conducted
to severe memory loss, complete disorienta- from a less severe condition to a more serious in accordance with FDA’s 2006 guidance on
tion, social withdrawal, loss of independence, one. Filling an unmet medical need is defined exploratory Investigational New Drug (IND)
and is fatal. as providing a therapy where none exists or studies designed to speed up development of
providing a therapy which may be potentially promising drugs by establishing very early on
application submitted—An application for superior to existing therapy. Once a drug
marketing approval has been submitted to the whether the agent behaves in human subjects
receives Fast Track designation, early and as was anticipated from preclinical studies.
U.S. Food and Drug Administration (FDA). frequent communication between the FDA and
The application can either be an NDA (new a drug company is encouraged throughout the Phase I—Researchers test the drug in a small
drug application) or a BLA (biologic license entire drug development and review process. group of people, usually between 20 and 80
application). The frequency of communication assures that healthy adult volunteers, to evaluate its initial
questions and issues are resolved quickly, with safety and tolerability profile, determine a
cognitive disorders—Disorders of the higher
the goal to achieve earlier drug approval and safe dosage range, and identify potential side
mental processes, including understand-
access by patients. effects.
ing, reasoning, knowledge, and intellectual
capacity. A person with a cognitive disorder, mild Alzheimer’s disease—A stage of Al- Phase II—The drug is given to volunteer
such as Alzheimer’s disease, does not process zheimer’s disease characterized by a series of patients, usually between 100 and 300, to see
information correctly within the brain, resulting changes in cognitive abilities that may include, if it is effective, identify an optimal dose, and to
in impaired awareness and judgment, difficulty memory loss for recent events, difficulty with further evaluate its short-term safety.
reasoning and focusing, loss of memory and problem solving, changes in personality, dif-
abnormal mental capacity. People with cogni- ficulty organizing and expressing thoughts, Phase III—The drug is given to a larger, more
tive disorders have problems acquiring, men- getting lost or misplacing belongings. This is diverse patient population, often involving be-
tally organizing and responding to information, the stage at which the disease is often first tween 1,000 and 3,000 patients (but sometime
which results in an inability to function normally diagnosed. many more thousands), to generate statistically
in everyday life situations. significant evidence to confirm its safety and
moderate Alzheimer’s disease—A stage effectiveness. They are the longest studies,
dementia—Loss of mental ability that inter- of Alzheimer’s disease characterized by and usually take place in multiple sites around
feres with normal daily activities. It lasts more increased confusion, greater memory loss, sig- the world.
than six months, it not present at birth and is nificant changes in personality, and the need
not associated with loss or altered conscious- for assistance with basic daily activities. These tauopathies—A group of neurodegenerative
ness. The natural decline of these functions changes are related to damage in areas of the diseases characterized by accumulation of
with age is grossly exaggerated in dementia. brain that control language, reasoning, sensory tau (τ) protein in the brain. Those diseases
processing, and conscious thinking. At this include Alzheimer’s disease, Pick’s disease,
Fast Track—A U.S. Food and Drug Admin- corticobasal degeneration, and other related
stage, patients may have problems recognizing
istration (FDA) process designed to facilitate disorders.
family and friends, experience hallucinations,
development and expedite the regulatory
Medicines in Development Alzheimer’s Disease 2012 9
11. The Drug Discovery, Development and Approval Process
Developing a new medicine takes an average of 10-15 years;
For every 5,000-10,000 compounds in the pipeline, only 1 is approved.
The Drug Development and Approval Process
The U.S. system of new drug approvals is in people. The IND shows results of previous statistically significant evidence to confirm its
perhaps the most rigorous in the world. experiments; how, where and by whom the safety and effectiveness. They are the longest
new studies will be conducted; the chemical studies, and usually take place in multiple sites
It takes 10-15 years, on average, for an
structure of the compound; how it is thought around the world.
experimental drug to travel from lab to U.S.
to work in the body; any toxic effects found in
patients, according to the Tufts Center for the New Drug Application (NDA)/Biologic
the animal studies; and how the compound
Study of Drug Development. Only five in 5,000 License Application (BLA). Following the
is manufactured. All clinical trials must be
compounds that enter preclinical testing make completion of all three phases of clinical trials,
reviewed and approved by the Institutional
it to human testing. And only one of those five a company analyzes all of the data and files an
Review Board (IRB) where the trials will be
is approved for sale. NDA or BLA with FDA if the data successfully
conducted. Progress reports on clinical trials
demonstrate both safety and effectiveness.
On average, it costs a company $1.2 billion, must be submitted at least annually to FDA and
The applications contain all of the scientific
including the cost of failures, to get one new the IRB.
information that the company has gathered.
medicine from the laboratory to U.S. patients,
Clinical Trials, Phase I—Researchers test Applications typically run 100,000 pages or
according to a 2007 study by the Tufts Center
the drug in a small group of people, usually more.
for the Study of Drug Development.
between 20 and 80 healthy adult volunteers, to
Approval. Once FDA approves an NDA or
Once a new compound has been identified in evaluate its initial safety and tolerability profile,
BLA, the new medicine becomes available
the laboratory, medicines are usually devel- determine a safe dosage range, and identify
for physicians to prescribe. A company must
oped as follows: potential side effects.
continue to submit periodic reports to FDA,
Preclinical Testing. A pharmaceutical com- Clinical Trials, Phase II—The drug is given including any cases of adverse reactions and
pany conducts laboratory and animal studies to volunteer patients, usually between 100 and appropriate quality-control records. For some
to show biological activity of the compound 300, to see if it iseffective, identify an optimal medicines, FDA requires additional trials
against the targeted disease, and the com- dose, and to further evaluate its short-term (Phase IV) to evaluate long-term effects.
pound is evaluated for safety. safety.
Discovering and developing safe and effective
Investigational New Drug Application (IND). Clinical Trials, Phase III—The drug is given to new medicines is a long, difficult, and expensive
After completing preclinical testing, a company a larger, more diverse patient population, often process. PhRMA member companies invested
files an IND with the U.S. Food and Drug involving between 1,000 and 3,000 patients (but an estimated $49.5 billion in research and
Administration (FDA) to begin to test the drug sometime many more thousands), to generate development in 2011.
