Pfizer Drug R&D Pipeline As of July 31, 2007
Pfizer Drug R&D Pipeline As of July 31, 2007
Pfizer Drug R&D Pipeline As of July 31, 2007
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Pfizer Pipeline – as of July 31, 2007 www.pfizer.com/pipeline
Table of Contents
Pfizer Pipeline
Phase I................................................................................................................................... 3
Phase II .................................................................................................................................. 4
Phase III ................................................................................................................................. 5
Registration ............................................................................................................................ 5
Recent Approvals .................................................................................................................... 5
Projects Discontinued from Development ................................................................................... 6
Phases of Development
The Phases of Clinical Development .......................................................................................... 7
Phase I ................................................................................................................................ 7
Phase II ............................................................................................................................... 7
Phase III .............................................................................................................................. 7
Registration ............................................................................................................................ 8
Recent Approvals .................................................................................................................... 8
Phase IV ................................................................................................................................ 8
Product Pipeline Therapeutic Areas
Allergy & Respiratory .............................................................................................................................. 9
Allergy & Respiratory Conditions ......................................................................................................... 9
Cardiovascular, Metabolic and Endocrine Diseases ............................................................................10
Cardiovascular, Metabolic and Endocrine Diseases Conditions .......................................................10
Dermatology ..........................................................................................................................................11
Dermatologic Conditions ....................................................................................................................11
Genitourinary.........................................................................................................................................12
Genitourinary Conditions ...................................................................................................................12
Gastrointestinal & Hepatology ..............................................................................................................13
Gastrointestinal & Hepatologic Conditions ........................................................................................13
Inflammation..........................................................................................................................................13
Inflammatory Conditions ....................................................................................................................13
Infectious Diseases ...............................................................................................................................14
Infectious Diseases and Conditions ...................................................................................................14
Neuroscience ........................................................................................................................................15
Neuroscience Conditions ...................................................................................................................15
Oncology ...............................................................................................................................................16
Oncologic Conditions .........................................................................................................................16
Ophthalmology ......................................................................................................................................17
Ophthalmic Conditions .......................................................................................................................17
Pain .......................................................................................................................................................17
Pain Conditions ..................................................................................................................................17
Pfizer Pipeline Snapshot ......................................................................................................... 18
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Phase I
Indicates that the project is either new, or has progressed in phase since the previous portfolio update of Pfizer.com
New indications or enhancements
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Phase II
Indicates that the project is either new, or has progressed in phase since the previous portfolio update of Pfizer.com
New indications or enhancements
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Phase III
Registration
Recent Approvals
Indicates that the project is either new, or has progressed in phase since the previous portfolio update of Pfizer.com
New indications or enhancements
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Phase I
Phase II
Phase III
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Phases of Development
New prescription medicines are developed through a series of carefully controlled phases, which
help to best determine the safety and efficacy of each new drug by applying the highest scientific
standards. After extensive preclinical testing of an experimental medicine, clinical studies are
conducted in volunteer study subjects across all phases of drug development. To ensure that such
studies are ethically conducted, careful attention is paid to the study design; investigator training;
external Institutional Review Board (IRB) or ethics committee review; monitoring of study sites; and
accurate presentation to potential study subjects of the risks and potential benefits of participation
through the informed consent process. The participant confirms his or her willingness to take part in
a study with a written, signed document called the informed consent. Informed consent is not a
contract, and participants are free to withdraw from the trial at any time.
Phase II
In Phase II clinical trials, the focus is on the experimental medicine’s effectiveness against an illness
or medical condition as well as its safety, side effects, and potential risks. During Phase II,
researchers also seek to determine the most effective dosages for the experimental medicine and
the most appropriate method of delivering it (e.g., tablets, extended release capsules, infusions,
injections, etc.). This stage involves a larger number of study subjects; typically up to several
hundred (although in some cases there could be fewer than 100). The subjects studied in Phase II
are usually patients who have the medical condition that the experimental medicine is intended to
treat, and who may be recruited by physicians at research centers, clinics, and hospitals around the
world.
Phase III
Phase III clinical trials are typically conducted in a larger population in order to confirm the results of
earlier studies and gather additional information about the effectiveness and safety of an
experimental medicine. This phase will usually involve several hundred to several thousand
subjects from multiple sites with many different physician-investigators. These trials are often
randomized and ―double-blinded.‖ ―Double blinded‖ means that during the study, neither the
investigator nor the subject know whether the subject is receiving the study drug, or a placebo
(sugar pill), or a comparator drug. Phase III studies generally provide the primary basis for the
benefit-risk assessment for the new drug and much of the core information about the drug that is
analyzed for inclusion in the drug’s labeling.
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Registration
The next step in bringing a new medicine to the market is the filing of an application with the health
regulatory authority of a country in order to obtain approval to market the new medicine. This step is
known as registration. In the US a New Drug Application (NDA) is filed with the U.S. Food and Drug
Administration (FDA). In Europe, a Market Authorization Application (MAA) is filed with the European
Agency for the Evaluation of Medicinal Products (EMEA). A description of the drug´s manufacturing
process along with all quality data and study results are provided to the health regulatory authorities
in order to demonstrate the safety and effectiveness of the new medicine. If approval is granted, the
new drug can then be made commercially available to patients.
Recent Approvals
Medicines that have recently been approved for marketing in the U.S. or Europe and are either
currently marketed and available to patients or about to be launched and made available in the near
future are known as "recent approvals."
Phase IV
Phase IV studies – also called ―post marketing studies‖ – are conducted after approval of a drug for
marketing. Through such studies, researchers can collect additional information about long–term
risks, benefits, and optimal use. These studies often involve thousands of subjects and may
continue for many years.
To learn more about Pfizer’s Phase IV studies (Post Marketing Commitments), please visit our
dedicated Post Marketing Commitments section at
www.pfizer.com/research/post_marketing_commitments.jsp.
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Dermatology
Wrinkles, baldness, oily skin, and acne are not life-threatening diseases, but many people suffering
from these conditions would describe them as affecting the quality of their lives and are therefore
seeking and willing to pay for a treatment that works. When they have blemishes or symptoms of
aging skin/scalp, consumers report that they feel their appearance can adversely affect their self-
perception, personal relationships, and even future career potential.
Life quality conditions can be not only uncomfortable and embarrassing for sufferers—they're also
expensive. People who attempt to self-treat their problems often spend thousands of dollars a year,
on everything from cosmetic products that don't truly work to expensive dermatology procedures and
plastic surgery. Pfizer's Dermatology TA is dedicated to developing new prescription medicines to
help close the gap in the availability of effective skin care products, bringing clinically proven
treatments, backed by rigorous testing for safety and effectiveness, to patients.
Dermatologic Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Alopecia — The loss of hair, or baldness. Often caused by heredity or hormonal imbalance,
Alopecia eventually affects most men as they age as well as some women, especially after
menopause. Pfizer aims to develop novel, effective treatments through three unique mechanisms:
potassium-channel openers, thyromimetics, and antiandrogens.
Wrinkles — Lines or creases in the skin. Caused by aging and sun exposure, wrinkles affect
everyone to some degree as they get older. Pfizer's goal is to develop an effective wrinkle-reducing
product that is significantly more active than any of the "standard" retinoids on the market with a
good tolerability profile and much less invasive than currently offered wrinkle-reducing procedures
such as BOTOX® or dermal fillers.
Oily skin/Acne — Excessively oily skin and pimples on the skin. Caused by overproduction of
sebum and inflammation of the follicular canal, oily skin and acne negatively impact the social and
emotional quality of life for many teenagers and adults. To address the gap in the market for a
topical prescription drug that reduces oil with no serious side effects, Pfizer is exploring several
early-stage compounds in its pipeline indicated for oily skin and mild-to-moderate acne. These
compounds target the skin's sebaceous glands and reduce the oily substance, called sebum—the
'food' that acne-causing bacteria feed on—produced by these glands.
Skin Improvement — Blotchy changes in the color of the skin or scarring of the skin. Skin changes
can result from aging (age spots) or hormonal changes ("melasma"—a dark "mask" that often
appears on the faces of pregnant or hormone-exposed women). In addition, scarring can occur as
the result of surgery, trauma, or the effects of inflammatory conditions such as acne.
BOTOX® is a registered trademark of Allergan Inc.
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Genitourinary
Genitourinary (GU) conditions account for a major source of distress for millions of people
throughout the world. While many GU conditions are manageable, patients often do not seek
treatment due to either the dismissal of these conditions as "merely quality of life" issues or the
embarrassment and misunderstanding associated with their symptoms and conditions. In response,
Pfizer is working to help these patients. Our goal is to restore dignity to those suffering from GU
conditions and help improve their quality of life.
Genitourinary Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Hot Flashes — Usually a symptom of menopause characterized by the sensation of heat in the face
and neck and sometimes associated with night sweats.
Lower Urinary Tract Symptoms — The collective term for an overlapping set of symptoms caused
by benign prostatic hyperplasia (non-cancerous enlargement of the prostate gland) and/or
overactive bladder. These symptoms include increased urgency and frequency of needing to pass
urine; the need to go to the bathroom two or more times a night (nocturia); incontinence; poor urine
flow and straining to pass urine. These symptoms have a profound impact on the quality of life of
millions of patients worldwide, often leading to social isolation, depression, lack of sleep, and acute
embarrassment. Pfizer is working to better understand patients' needs in order to help create a more
patient-centric, symptom-related diagnosis, as well as novel treatments to relieve patients' most
bothersome symptoms.
Incontinence — The inability to control the flow of urine from the bladder.
Overactive Bladder — A condition in which the muscle in the bladder (the detrusor) is too active,
causing frequent, strong and sudden urges to urinate even when the bladder is not full. In addition to
urgency, symptoms include urinary frequency and involuntary leakage of urine.
Stress Incontinence — The involuntary leakage of urine from the bladder caused by a sudden rise
of pressure in the abdomen, often due to coughing, sneezing or laughing.
Mixed Incontinence — The involuntary leakage of urine due to a combination of overactive bladder
and stress incontinence.
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Gastroesophageal Reflux Disease (GERD) — Movement of acidic stomach contents back into the
esophagus, leading to symptoms including heartburn. GERD affects 50 million people in the U.S.,
with an estimated 20 percent dissatisfied with their current medication and its ability to relieve and
control their symptoms. Pfizer is working to investigate novel ways to bring greater relief to patients
with this unpleasant disease.
Liver Fibrosis — Refers to the scarring of the liver caused by chronic viral hepatitis (Hepatitis B or
C) or fatty liver (related to obesity). If the fibrosis is left untreated, the condition can progress to
cirrhosis for which the only treatment is liver transplant. While there are no current therapies to treat
this disease, which affects some 15 million patients in the U.S. alone, Pfizer is leading research for
medicines to treat liver fibrosis halting, or even reversing, its progression toward cirrhosis.
Inflammatory Bowel Disease (IBD) — Ulcerative Colitis and Crohn's Disease — Inflammation
and/or ulceration of the inner lining of the large intestine (colon), characterized by abdominal pain,
diarrhea, and rectal bleeding. IBD adversely affects many patients' lives, often leading to sleep loss
as well as career and social implications. Pfizer is working to develop new, more effective
approaches, including biological medicines, to treat IBD.
Inflammation
The body's first natural response to wounds and infections is the inflammatory response. However,
in diseases such as Rheumatoid Arthritis, the body's immune system can be activated without
stimulus or infection, attacking its own healthy tissues. And in other situations such as
transplantation, it becomes necessary to suppress the immune system to ensure that the body does
not attack the new organ as a foreign invader. Many current therapies leave transplant patients in a
vulnerable position due to their many side effects.
Our researchers are working on medicines that will make this less of a balancing act, reducing the
risk of side effects and making them more manageable. Some of our most important candidates are
derived from our leading-edge work in identifying kinases—enzymes that "switch on" other enzymes.
To date, 214 kinases have been implicated in various diseases.
Another active area of pursuit is osteoarthritis, often called "wear and tear" arthritis, although the
disease actually reflects a much more dynamic process of a change in the balance of joint cartilage
destruction and healing that goes on continuously. This form of arthritis is very common—almost
everybody will suffer osteoarthritis in some joint or other as they age.
Inflammatory Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Osteoarthritis — Deterioration of the cartilage in the joints between bones, causing pain, stiffness,
and loss of function.
Rheumatoid Arthritis — Inflammation of the lining of the joints, particularly of the hands and feet,
causing swelling, pain, stiffness, and joint destruction.
Transplant Rejection — Prevention of the body’s immune response and attack on a donor organ.
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Infectious Diseases
Pfizer has a proud tradition of discovering and developing medicines that have truly benefited global
health care through the treatment of infectious diseases. From Mansil® and Diflucan® in the '70s
and '80s to Vfend® and Eraxis® today, we are proud that our medicines have helped save countless
lives worldwide, and continue to do so.
However, the nature of infectious diseases is that they change and develop new strains that are
resistant to current therapies. As recent history has shown, there is always the possibility of a new
infectious disease emerging with little or no warning. The most significant example of this in recent
history is, of course, HIV/AIDS. Pfizer is breaking new ground in our approaches to the treatment of
HIV, not least with maraviroc, currently in registration, and granted an accelerated review by both
the U.S. and European regulatory agencies. We are exploring a number of other approaches in
research and development to find new treatments for HIV/AIDS.
In 2006, Pfizer acquired the British company PowderMed, giving us the ability to discover and
develop not just medicines, but vaccines to treat infectious diseases, and influenza in particular.
PowderMed brings with it a novel DNA vaccine technology platform, as well as two potential
influenza vaccines designed for the company's innovative, needle-less intradermal delivery method.
Bacterial Infections — Infections in patients in either the community or hospital setting, most
notably involving multidrug-resistant bacteria strains.
Fungal Infections — Medicines with the ability to treat a spectrum of infections caused by different
kinds of fungi.
o Aspergillosis — A specific type of fungal infection which can particularly affect the lungs,
bronchial airways, sinus cavities, eyes and ears, especially in those with weakened immune
systems.
o Esophageal Candidiasis — A fungal infection (of the genus Candida) within the esophagus.
o Invasive Candidiasis/Candidemia — An infection of the bloodstream by the Candida fungus,
which can spread throughout the whole body and most frequently occurs in hospitalized
patients.
Hepatitis C Virus — A virus that causes inflammation of the liver, usually transmitted through blood
or sexual contact.
Human Immunodeficiency Virus (HIV) — The virus that causes AIDS (Acquired Immune
Deficiency Syndrome) which destroys the body’s immune system and ability to fight infection and
disease.
Malaria — Transmitted by Anopheles mosquito bites, malaria is a parasitic infection causing chills
and fever and can lead to death.
Skin and Skin Structure Infections — Caused by bacteria, including multidrug-resistant strains.
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Neuroscience
In the U.S. today, 7 of the 10 leading causes of disability are neurological and psychiatric disorders.
To meet these patient needs, Pfizer is taking a bold leadership approach that will evolve from
dealing with symptoms to modifying diseases, where scientifically feasible. As a result, Pfizer has
new approaches to attack Alzheimer’s disease, schizophrenia and other feared conditions. For
anxiety, sleep disorders, and neuropathic pain, we continue to expand inquiry into alpha-2-delta
binding site agents, the mechanism that has already led to the development of Neurontin® and
Lyrica®.
Neuroscience Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Alzheimer´s Disease — A progressive disorder characterized by the loss of personal and factual
memory and a decline in cognitive ability, it is often accompanied by a sense of disorientation. It is
only in the last few years that researchers have truly come to understand the causes of Alzheimer's,
its effect on the brain, and how and why it kills brain cells causing the devastation of many families,
and changing friends and loved ones into completely different people. Coupled with this is the wider
appreciation and understanding about a disease no longer considered to be just a normal part of the
aging process. Despite this growing knowledge, Alzheimer's remains one of the world's most
undiagnosed diseases, with only an estimated third of the world's Alzheimer's sufferers (estimated to
be 18 million people) receiving treatment. Through years of scientific research to help gain
understanding, the Neuroscience team now has a multitude of potential treatments for Alzheimer's in
research and development. Coupled with this are the team's efforts to develop an effective tool to
detect Alzheimer's early and if possible before onset of the disease. Pfizer's commitment to finding
new medicines to treat Alzheimer's was cemented in 2006 with the acquisition of Rinat Bioscience,
and partnership with Transtech Pharma.
Epilepsy — A disorder of the nervous system resulting from electrical activity in the brain, and
characterized by seizures.
General Anxiety Disorder — An uncontrollable worry about everyday things which can often impair
a patient´s normal daily functioning.
Insomnia — The persistent inability to fall asleep or remain asleep throughout the night.
Bipolar Disorder, Manic Depressive Illness — A major mood disorder in which patients cycle
between periods of depression or mania.
Panic Disorder — An anxiety disorder characterized by short but disabling periods of intense fear
and worry, often accompanied by rapid heart beat and dizziness.
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Oncology
Cancer causes more deaths every year in the U.S. than any other medical condition, with the
exception of heart disease.
Pfizer is becoming a global force in oncology. Researchers are working to find treatments that focus
on specific targets important in tumor growth and patient survival. In early 2006, the FDA approved
the Pfizer drug Sutent® to treat rare forms of intestinal and kidney cancers. Its novel mechanism
both cuts off the blood supply to the cancer and destroys cellular reproduction. Sutent is now also in
trials for the treatment of breast, lung, and colorectal cancer.
Sutent is not the only medicine in Pfizer trials to treat these forms of cancer, and in addition the
Pfizer portfolio contains medicines currently being investigated for the treatment of stomach, liver,
prostate, pancreas and melanoma forms of cancer.
Pfizer's approach to the fight against cancer focuses on four different methods of treatment:
o Angiogenesis Inhibition: blocking the growth of the blood vessels which grow to, and 'feed',
cancerous tumors.
o Immunotherapy: 'awakening' the body's immune system to help better fight cancer.
o Signal Transduction Inhibition: stopping the abnormal signals within cancer cells.
o Cytotoxics/Potentiators: exploiting the defects in cancer cells to stop them from repairing and
replicating
Oncologic Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Cancer — Approaches for single medicines that treat multiple types and locations of cancer.
Colorectal Cancer — Cancer of the colon (large intestine) or the rectum (the end of the large
intestine).
Melanoma — A malignant skin tumor that begins in the cells that produce skin coloring
(melanocytes).
Lung Cancer — The abnormal growth of cells in lung tissue. Lung cancer is the leading cause of
cancer death in the U.S.
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Ophthalmology
The incidence of eye disease is growing as the world's population ages and suffers increasingly from
conditions such as diabetes. Pfizer is building on its expertise in treating diseases of the eye,
including glaucoma and retinal diseases, such as age-related macular degeneration (AMD) and
diabetic macular edema (DME), to expand its portfolio of ophthalmic compounds and improve the
treatment options available to patients worldwide.
Ophthalmic Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Age-related Macular Degeneration (AMD) — Damage to the retina, usually in adults over 55,
leading to vision loss. Pfizer currently produces Macugen® for the treatment of wet Age-related
Macular Degeneration. Macugen, while proving to be an effective medicine for the treatment of
AMD has to be taken, on a periodic basis, through direct injection into the eye. Our research is now
concentrating on discovering and developing a new medicine with a longer duration of action so that
it does not have to be injected as frequently.
Diabetic Macular Edema — Thickening of the retina due to the abnormal accumulation of fluid in
the retina, causing visual blurring; may progress to vision loss if untreated.
Glaucoma — A group of disorders that, if untreated, may lead to damage to the optic nerve.
Damage to the optic nerve may lead to vision loss, and may progress to blindness. Most people with
glaucoma have elevated fluid pressure in the eye, a condition known as increased intraocular
pressure. Glaucoma is the leading cause of blindness in the United States today with more than two
million patients suffering from the most common form — open angle glaucoma.
Pain
In recent years there have been very few breakthrough medicines for the treatment of chronic pain,
with many of the current standard medicines dating back decades (if not centuries). The result of this
is that there are still millions of patients across the world for whom there is no adequate medicine to
treat their pain. The impact of pain is profound. Frequent sufferers are stopped from working,
sleeping, and socializing with a common result of depression.
But, Pfizer's pain team is hopeful that new insights into the causes of pain, as well as how to actually
'measure' it, can help usher in a series of new medicines that will provide greater relief from the
symptoms of pain, allowing patients to return to normal lives at work and at home.
The 'holy grail' for our researchers is what they call the 'magic bullet' for pain. This medicine would
be effective against a variety of different types of pain, providing more effective and safer relief from
symptoms than current medicines.
Pain Conditions
Indications for medicines currently in phases of development, from Phase I through recent approval:
Acute Pain — The sudden onset of pain that lasts for a short time.
Neuropathic Pain — Pain caused by nerve damage or damage to the nervous system. Diabetic
neuropathy is pain caused by damage to the spine and nerves as a specific result of diabetes.
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provide medical advice or guidance, and should not be used for that purpose. Medical use of any product should be strictly in
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27 Programs Advanced*
Discovery
Projects
+7 +14 +3 +1 +2
13 Programs Discontinued
* Pipeline represents progress of R&D programs since 12/06, across 11 therapeutic areas,
including: Cancer, Heart Disease, Pain, Neurological Disorders and Infectious Diseases.
Included are 85 New Molecular Entities plus 14 Additional Indications.
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Pfizer Pipeline
Page 19 of 19