06.08.2007 20:33:00
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Pfizer Says Growth in Phase II Portfolio Supports Goal of Tripling Phase III Portfolio by 2009
Pfizer said today that it now has a total of 47 programs in its Phase II
Research and Development pipeline, which is the largest Phase II cohort
in its history and represents continued progress toward its target of
tripling the company’s Phase III portfolio by
2009.
"The growth of our Phase II cohort is
encouraging progress toward meeting our target for our Phase III
portfolio by 2009,” said Pfizer’s
Chairman and Chief Executive Officer Jeff Kindler. "With
the progress we are seeing in our pipeline -- as well as our efforts in
reducing our attrition rates – we are also
continuing to target having a steady stream of new medicines from our
internal R&D, four a year, starting in 2011. Our portfolio is very
promising and focused on markets where we see substantial opportunities
to meet unmet medical needs with innovative science and technology. We
will continue to sharpen the focus and simplify the structure of our R&D
organization so that we bring our pipeline forward to commercialization
as rapidly as possible and enhance our productivity in all aspects of
our clinical work.”
The pipeline update, posted today at http://www.pfizer.com/pipeline,
provides information on progress of candidates since the posting last
December:
There are now 99 total programs, with 38 in Phase I, 47 in Phase II,
11 in Phase III and three in registration, awaiting action from
regulatory authorities.
Three compounds have entered Phase III, 14 have entered Phase II, and
seven have entered Phase I.
Phase II now includes 47 programs, reflecting the success of the
company’s ongoing efforts to increase R&D
productivity and reduce attrition at this key phase of development –
14 compounds were added while only four were discontinued. Phase II
covers a wide range of therapeutic areas, and it is advancing
potential new and innovative treatments across a broad spectrum of
unmet medical needs.
The pipeline includes 20 potential treatments for cancer; 16 for
cardiovascular, metabolic and endocrine diseases; 17 for pain and
inflammation; 17 for neurological disorders and 10 for infectious
diseases. Others areas represented include gastrointestinal,
genitourinary, ophthalmology, dermatology and allergy/respiratory.
Overall a total of 13 programs were discontinued.
The development pipeline now has a total of 14 biologic compounds,
including vaccines and antibodies designed to treat cancer, rheumatoid
arthritis, influenza and other serious medical conditions. Pfizer is
making significant internal and external investments to further expand
its presence in biologics and capitalize on attractive development
opportunities.
While the total number of Phase I compounds has declined since the
December, 2006 update and now stands at 38, reflecting both transfers
to Phase II and some attrition, the majority of Pfizer’s
Phase I starts are targeted for the second half of 2007.
The update includes 85 New Molecular Entities plus 14 potential new
indications or enhancements for medicines including Lyrica, Geodon,
maraviroc, and Eraxis and Vfend, among others.
"The continuing momentum in our pipeline and
the progress we are making in advancing important new compounds are
tangible evidence that the changes we’ve made
in our organization are having real impact where it matters most: the
breadth and depth of our pipeline,” said John
LaMattina, President of Pfizer Global Research and Development, who
announced his plans to retire from the company earlier this year.
"In the last eight months, we have advanced
27 programs, with the loss of just 13. Our progress is especially
gratifying since we are continuing to make major structural and
organizational changes while we pursue all of these opportunities. We
are revising the allocation of our capital so that we target the areas
of greatest medical and commercial promise, and I am confident that you
will see Pfizer bring forward significant new therapies to fight cancer,
cardiovascular disease, neurological disorders, infections and many
other conditions. This performance is remarkable in a period of profound
change and is a testament to the commitment and dedication of my
colleagues in Pfizer Global Research & Development,”
he added.
Research focus continues on areas of
high medical need
Highlights of today’s update include new
information on five of Pfizer’s 11
therapeutic areas: 1) oncology; 2) cardiovascular, metabolic and
endocrine disease; 3) pain; 4) the neuroscience portfolio; and 5)
infectious diseases.
Oncology is a major focus
of Pfizer’s medical research. The company
invests more than 20% of its development budget in this area with 20
active programs in immunotherapy, angiogenesis inhibition and signal
transduction inhibition. The pipeline includes potential treatments
across numerous tumor types, underscoring the company’s
multidimensional approach to cancer treatment. The company now has
compounds either in or nearing Phase III that, in total, address more
than 70 percent of deaths due to various cancer types.
Sutent was launched late last year to treat renal cell
carcinoma and gastrointestinal stromal tumors. Pfizer’s
Phase III study using Sutent in patients with non-small cell lung
cancer and breast cancer are progressing well, and Pfizer recently
dosed its first patient in its new colorectal Phase III study. Pfizer
is also pursuing axitinib for the treatment of thyroid and pancreatic
cancers, and there is new data showing that it prolonged overall
survival in advanced pancreatic cancer when combined with standard
care chemotherapy. The first patient in the Phase III pancreatic
cancer trial was dosed in July.
The investigational compound CP-751871, which works by a novel
mechanism of action, represents a new generation of immunotherapy and
showed favorable survival outcomes in patients with metastatic
melanoma with limited treatments options. CP-675206 continues
in Phase III testing for melanoma, with data expected to be available
in 2008.
Pfizer continues to build on its traditional strengths in cardiovascular
research and has expanded in metabolic and endocrine diseases.
Apixaban, a compound being investigated for the prevention and
treatment of a broad range of venous and arterial thrombotic conditions,
is being jointly developed with Bristol-Myers Squibb. Phase II trials
for thrombosis treatment have been completed. Phase III trials in venous
thromboembolism prevention in patients undergoing total knee replacement
surgery will seek to demonstrate superiority to enoxaparin, and Phase II
trials are evaluating apixaban for acute coronary syndrome. Phase III
trials are also underway to study apixaban for the prevention of stroke
in patients with atrial fibrillation.
Today’s update also reflects Pfizer’s
intention to resubmit its new drug application for lasofoxifene,
a selective estrogen receptor modulator for the treatment of
osteoporosis, with new data in December of this year. Other compounds
include CP-945598, a potential new treatment for obesity now in
Phase III studies, and CP-533536, a compound in Phase II for
bone healing, where Pfizer is now consulting with outside experts to
develop broader clinical trials and expand its information base.
The updated pipeline shows eight candidates for pain,
with an additional nine in the related area of inflammation.
The company's scientists are now developing many innovative compounds
aimed at novel, recently-discovered biological targets with the
potential to alter, reduce or block the transmission of pain signals.
For S,S-reboxetine (a selective norepinephrine reuptake
inhibitor), Pfizer is encouraged by the data from a Phase II trial in
patients with fibromyalgia. Phase II trials have progressed as
monotherapy or in combination with Lyrica for post-herpetic neuralgia. A
Phase II trial is being planned for painful diabetic neuropathy.
For PF-4383119, Pfizer has completed a Phase IIa trial in
osteoarthritis with a positive read-out. As a result, the company will
complete a multi-dose trial in osteoarthritis and initiate studies in
other settings of pain this year. For PF-592379, a Phase II
trial just started comparing against oxycodone in severe
osteoarthritis pain.
In neuroscience, Pfizer
received approval during the period for Lyrica’s
fibromyalgia indication, an important line extension in the U.S. Lyrica
is currently in Phase III testing for epilepsy monotherapy and
Generalized Anxiety Disorder (GAD) in the U.S., as well as Phase II for
restless leg syndrome. Geodon is another in-line Pfizer medicine
with potential new indications: it is in Phase II for adjunctive bipolar
depression and Phase III for bipolar relapse prevention.
Pfizer also continues work on alpha-2-delta compounds for patients
with neurological disorders, and it is proceeding with broad
confirmatory development of PD-332334, now in Phase II, for the
treatment of GAD. Pfizer scientists continue to believe that molecules
with this mechanism of action are potentially important new therapies
for the treatment of illnesses including insomnia and vasomotor
symptoms. Pfizer also has several new approaches to the treatment of
Alzheimer’s disease in ongoing Phase II
clinical trials.
In infectious diseases,
Pfizer scientists are working on new treatments for diseases that have a
devastating impact of many parts of the world, including malaria,
hepatitis C and HIV/AIDS. Today we announced FDA approval for SelzentryTM
(maraviroc), for the treatment of HIV in treatment-experienced patients.
Maraviroc is also in Phase II testing for rheumatoid arthritis.
Pfizer is also currently in Phase III testing for a combination Zithromax/
chloroquine tablet to treat malaria. Its Phase II portfolio
includes two potentially new HIV treatments, and it has another Phase
II program underway to study two in-line medicines -- Eraxis and Vfend
-- in combination to treat fungal infections.
"We will continue to update our pipeline so
that investors, doctors, the scientific community, patients and their
families can see how our research is advancing,”
said Mr. Kindler. "These updates are an
important part of our commitment to transparency in all aspects of our
operations, and we look forward to reporting on our continuing progress.”
DISCLOSURE NOTICE: The information contained in this release is as of
August 6, 2007. Pfizer assumes no obligation to update any
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about various products
in development and potential additional indications for various in-line
products, including their potential benefits, as well as targets with
respect to the advancement of product candidates within the Company’s
research and development pipeline, that involve substantial risks and
uncertainties. Such risks and uncertainties include, among other things,
the uncertainties inherent in research and development; decisions by
regulatory authorities regarding whether and when to approve any drug
applications and supplemental drug applications that may be filed for
such products in development and such additional indications for in-line
products as well as their decisions regarding labeling and other matters
that could affect the availability or commercial potential of such
products and such additional indications; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2006
and in its reports on Form 10-Q and Form 8-K.
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