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Spring 2003
Quality Of Life Survey Results
In Patients
With Pituitary Tumors
Survey results published spring 2003 in the journal Quality Management
in Health Care.
Preliminary Study
Results.


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New Treatments!
US FOOD AND DRUG ADMINISTRATION APPROVES
SOMAVERT® FOR THE TREATMENT OF ACROMEGALY
First in a new class of medicines treats debilitating
hormone disease
Peapack, N.J. (March 26, 2003) ¾ Pharmacia
Corporation (NYSE:PHA) announced today that the US Food and Drug
Administration (FDA) has approved SOMAVERT® (pegvisomant for
injection) for the treatment of acromegaly in patients who have
had an inadequate response to surgery and/or radiation therapy and/or
other medical therapies, or for whom these therapies are not appropriate.
The goal of treatment is to normalize serum IGF-I levels.
Acromegaly is a serious, life-shortening disease
triggered by over-secretion of growth hormone, most often caused
by a pituitary tumor. This excess of growth hormone leads to overproduction
of a second hormone, IGF-I (insulin-like growth factor-l), which
contributes to the disabling symptoms and the long-term health problems
associated with the disorder. Patients with acromegaly often suffer
from headache, excessive sweating, soft-tissue swelling, joint disorders
and, perhaps most striking, a progressive coarsening of facial features
and enlargement of the hands, feet and jaw. Patients with acromegaly
face a mortality rate two to four times higher than the average
person, due to such serious long-term complications as heart and
respiratory disease, diabetes mellitus and some forms of cancer.
SOMAVERT is the first in a new class of medicines
called growth hormone receptor antagonists and the only medicine
designed to specifically block the effects of excess growth hormone
in acromegaly. It will be available in the US by prescription within
the next few weeks. SOMAVERT was approved by the European Commission
in November 2002.
“SOMAVERT is an important medical advance
that offers new hope to patients with acromegaly,” said Ariel
Barkan, MD, Professor of Internal Medicine, Professor of Neurosurgery
and Co-director of the Pituitary and Neuroendocrine Center, University
of Michigan Health Systems, and clinical investigator for SOMAVERT.
“We are very encouraged by the introduction of SOMAVERT, an
important new treatment option for those who are suffering the ravages
of this disease,” said Robert Knutzen, acromegaly patient
and CEO/Chairman of the Pituitary Network Association, an international
non-profit organization dedicated to providing support and information
to patients with pituitary disorders.
SOMAVERT was studied in a fixed-dose, randomized
clinical trial and in a long-term, open-label, dose-adjusted study
in patients with acromegaly. In the pivotal study, SOMAVERT normalized
IGF-I levels in up to 82 percent of patients, and in the long-term
study, SOMAVERT normalized concentrations of IGF-I in 92 percent
of patients. IGF-I level is a biochemical measure of the severity
of acromegaly.
“We are excited to bring to market a new
treatment for patients with acromegaly,” said Peter Rost,
MD, Vice President, Endocrine Care, Pharmacia Corporation. “The
addition of SOMAVERT to our portfolio of products to treat pituitary
disorders further strengthens our commitment to global leadership
in endocrine care.”
The number of patients diagnosed with acromegaly
in the US, Europe and Japan is in the tens of thousands. Experts
believe the prevalence may be higher, as diagnosis is often delayed
for up to 15 years after symptoms begin.2 Traditional treatments
for acromegaly include surgery to remove the pituitary tumor, radiation
therapy and pharmaceutical treatments.
In clinical studies, elevations of liver tests
(ALT and AST) greater than ten times the upper limit of normal were
reported in two patients (0.8%) exposed to SOMAVERT. Serial monitoring
of liver tests is necessary when beginning and during therapy with
SOMAVERT. The most commonly reported adverse events with SOMAVERT
occurring
in at least ten percent of patients and at frequencies greater than
placebo were infection, pain, diarrhea, nausea, flu syndrome, abnormal
liver function tests, and injection-site reactions. The majority
of reported adverse events were of mild to moderate intensity and
limited duration. SOMAVERT is contraindicated in patients with hypersensitivity
to any of its components. The stopper on the vial of SOMAVERT contains
latex.
Pharmacia has an established and leading presence
in the field of endocrine care.
Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical
company whose innovative medicines and other products save lives
and enhance health and wellness. Pharmacia's 43,000 people work
together with many diverse stakeholders to bring these benefits
to people around the world, and to create new health solutions for
the future. On July 15, 2002, Pharmacia and Pfizer Inc. (NYSE:PFE)
announced the signing of a definitive agreement providing for Pfizer
to acquire Pharmacia in a stock-for-stock transaction.
For additional patient product information, please
contact 1-888-691-6813. For physician/pharmacist information, please
contact 1-800-323-4204.
For additional information on Pharmacia, please visit www.pharmacia.com.
For additional patient product information, please
contact 1-888-691-6813. or click on link www.somavert.com
for patient product information website.
Media Contact
Alma Gregory Baird
908 901 1290 Analyst Contact
Alex Kelly
908 901 7028
SOMAVERT® is a registered trademark of
Pharmacia Corporation.


Latest News December 2002
EUROPEAN COMMISSION APPROVES
SOMAVERT® FOR THE TREATMENT OF ACROMEGALY
First in a new class of medicines treats debilitating hormone disease
Peapack, N.J., November 19, 2002 -
Pharmacia Corporation (NYSE:PHA) announced today that the European
Commission has approved SOMAVERT® (pegvisomant powder and solvent
for solution for injection) for the treatment of patients with acromegaly
who have had an inadequate response to surgery and/or radiation
therapy and in whom an appropriate medical treatment with somatostatin
analogues did not normalise IGF-I concentrations or was not tolerated.
Acromegaly is a serious, life-shortening disease
triggered by over-secretion of growth hormone, most often caused
by a pituitary tumour. This excess of growth hormone leads to overproduction
of a second hormone, IGF-I, (insulin-like growth factor-l), which
causes the disabling symptoms and the long-term health problems
associated with the disorder.
SOMAVERT is the first in a new class of medicines
called growth hormone receptor antagonists. SOMAVERT was studied
in a randomised clinical trial and in two long-term open label dose
adjusted studies in patients with acromegaly. In the long-term studies,
SOMAVERT normalised concentrations of IGF-I in more than 90 percent
of patients. IGF-I is a measure of the activity of acromegaly, and
achieving a normal IGF-I level is a fundamental goal of acromegaly
treatment.
SOMAVERT is the first and only medicine designed
to specifically block the effects of growth hormone and is currently
under review by the US Food and Drug Administration (FDA).
“SOMAVERT is a significant advance in the
medical management of acromegaly,” said Peter J. Trainer,
BSc, MD, FRCP, Consultant Endocrinologist, Christie Hospital, Manchester,
U.K. and lead author of the pivotal SOMAVERT study published by
the New England Journal of Medicine. “The approval of this
medicine ensures that patients in Europe suffering from acromegaly
will soon have access to an additional effective medical treatment
for this disease.”
“Now that we have the Commission's approval,
we look forward to making this important new treatment available
to patients in Europe suffering from acromegaly in the coming months,”
said Peter Rost, MD, Vice President, Endocrine Care, Pharmacia Corporation.
“The development of SOMAVERT is another example of our commitment
to global leadership in endocrine care.”
Patients with acromegaly often suffer from headache,
excessive sweating, soft-tissue swelling, joint disorders and, perhaps
most striking, a progressive coarsening of facial features and enlargement
of the hands, feet and jaw. Untreated, patients with acromegaly
face a mortality rate two to four times higher than the average
person, due to such serious long-term complications as heart and
respiratory diseases, diabetes mellitus and some forms of cancer.
The number of people with acromegaly is estimated at 40,000 in Europe,
the USA and Japan, but experts believe the prevalence may be much
higher as diagnosis is often delayed for up to 15 years after symptoms
begin. Traditional treatments for acromegaly include surgery to
remove the pituitary tumour, radiation therapy and pharmaceutical
treatments.
SOMAVERT is contraindicated in patients with hypersensitivity
to pegvisomant or any of the excipients. In clinical studies, the
most commonly reported adverse events with SOMAVERT occurring in
at least 5% of patients were injection site reactions, sweating,
headache and asthenia. Lab tests to monitor liver function are recommended
during the first six months of therapy with SOMAVERT.
Pharmacia has an established and leading presence
in the field of endocrine care. The Company markets GENOTROPIN®
(somatropin [rDNA origin] for injection), the world's leading growth
hormone, for the treatment of growth hormone deficiency (GHD) in
children and adults, Prader-Willi Syndrome and in children born
Small for Gestational Age (SGA). It also markets DOSTINEX® (cabergoline
tablets) for the treatment of hyperprolactinemia.
Pharmacia Corporation (NYSE:PHA) is a top-tier
global pharmaceutical company whose innovative medicines and other
products save lives and enhance health and wellness. Pharmacia's
43,000 people work together with many diverse stakeholders to bring
these benefits to people around the world, and to create new health
solutions for the future. On July 15, 2002, Pharmacia and Pfizer
Inc. (NYSE: PFE) announced the signing of a definitive agreement
providing for Pfizer to acquire Pharmacia in a stock-for-stock transaction
that is expected to close by the end of 2002.
SOMAVERT®, GENOTROPIN® and DOSTINEX®
are registered trademarks of Pharmacia Corporation.

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