CHMP Opinion Based on Positive Benefit/Risk Assessment in Patients
with Hypercalcemia Due to Primary Hyperparathyroidism and Where
Parathyroidectomy is Not Clinically Appropriate or is Contraindicated
Amgen (Europe) GmbH today announced that the European Committee for
Medicinal Products for Human Use (CHMP) has issued a positive opinion
recommending the extension of the marketing authorization for Mimpara® (cinacalcet) in the European Union (EU) for the reduction of
hypercalcemia in patients with primary hyperparathyroidism (PHPT) for
whom parathyroidectomy would be indicated on the basis of serum calcium
levels (as defined by relevant treatment guidelines), but in whom
parathyroidectomy is not clinically appropriate or is contraindicated.
"As Amgen is committed to providing treatment
options for grievous illnesses where no other treatment options are
available, we are pleased with the CHMP´s
decision to grant Mimpara with a positive opinion. Patients with PHPT
and hypercalcemia, where surgery is not an option, may now benefit from
this new treatment," said Willard Dere, M.D.
senior vice president and chief medical officer, Amgen International. "The
expected new indication is a positive demonstration of Mimpara´s
favorable efficacy and safety profile in these patients."
The CHMP positive opinion for Mimpara is based on a positive
benefit/risk assessment in a patient population that currently has no
other long-term treatment options available to them. As part of the CHMP
review, Amgen´s clinical efficacy and safety
Mimpara data from patients with hypercalcemia due to PHPT in whom
surgery was not a treatment option were evaluated. Following the review
the CHMP concluded that Mimpara fulfills an unmet medical need for this
patient population with uncontrolled hypercalcemia.
About PHPT
PHPT is an endocrine disorder caused by the enlargement of one or more
of the four parathyroid glands and resulting in the release of excess
parathyroid hormone (PTH). PTH regulates the amount of calcium and
phosphorus in the body and plays an important role in several body
systems including the skeletal, gastrointestinal, renal, muscular, and
central nervous systems.
The majority of patients with PHPT requiring an intervention are treated
surgically by parathyroidectomy, however this is not a suitable
treatment option for a small proportion of patients.
About Mimpara
Mimpara® (cinacalcet) (also known as Sensipar® in the United States, Australia and Canada) is a calcimimetic agent that
is approved for the treatment of secondary hyperparathyroidism (SHPT) in
patients with chronic kidney disease receiving dialysis.
Calcimimetics amplify the action of calcium on the calcium-sensing
receptors on the parathyroid gland, thereby decreasing the secretion of
PTH. Mimpara is the first and only calcimimetic agent approved for use
in dialysis patients to specifically bind to and directly modulate the
calcium-sensing receptor on the surface of the chief cell of the
parathyroid gland while simultaneously lowering blood calcium and
phosphorus levels. In dialysis patients, Mimpara significantly reduces
PTH levels while simultaneously lowering blood calcium and phosphorus
levels. Mimpara binds to the parathyroid gland´s
calcium-sensing receptors, making them more sensitive to calcium, which
causes the gland to reduce its release of PTH.
The threshold for seizures may be lowered by reductions in calcium
levels and, infrequently, seizures have been reported with use of
Mimpara. The most commonly reported side effects are nausea and
vomiting. In post-marketing safety surveillance, isolated, idiosyncratic
cases of hypotension and/or worsening heart failure have been reported
in patients with impaired cardiac function, in which a causal
relationship to cinacalcet could not be completely excluded and may be
mediated by reductions in serum calcium levels.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s
promise by bringing safe and effective medicines from lab, to
manufacturing plant, to patient. Amgen therapeutics have changed the
practice of medicine, helping millions of people around the world in the
fight against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically
improve people´s lives. To learn more about
our pioneering science and our vital medicines, visit www.amgen.com.
Forward-Looking Statement
This news release contains forward-looking statements that are based on
management´s current expectations and beliefs
and are subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those described.
All statements, other than statements of historical fact, are statements
that could be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or clinical
results or practices, customer and prescriber patterns or practices
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully described
in the Securities and Exchange Commission (SEC) reports filed by Amgen
including Amgen´s most recent annual report
on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.
Please refer to Amgen´s most recent Forms
10-K, 10-Q and 8-K for additional information on the uncertainties and
risk factors related to our business. Unless otherwise noted, Amgen is
providing this information as of April 25, 2008 and expressly disclaims
any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may
differ materially from those we project. Discovery or identification of
new product candidates or development of new indications for existing
products cannot be guaranteed and movement from concept to product is
uncertain; consequently, there can be no guarantee that any particular
product candidate or development of a new indication for an existing
product will be successful and become a commercial product. Further
preclinical results do not guarantee safe and effective performance of
product candidates in humans. The complexity of the human body cannot be
perfectly, or sometimes, even adequately modeled by computer or cell
culture systems or animal models. The length of time that it takes for
us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. We develop product candidates internally and
through licensing collaborations, partnerships and joint ventures.
Product candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or as
safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the market.
Our business may be impacted by government investigations, litigation
and products liability claims. We depend on third parties for a
significant portion of our manufacturing capacity for the supply of
certain of our current and future products and limits on supply may
constrain sales of certain of our current products and product candidate
development.
In addition, sales of our products are affected by the reimbursement
policies imposed by third-party payors, including governments, private
insurance plans and managed care providers and may be affected by
regulatory, clinical and guideline developments and domestic and
international trends toward managed care and healthcare cost containment
as well as U.S. legislation affecting pharmaceutical pricing and
reimbursement. Government and others´ regulations and reimbursement policies may affect the development, usage
and pricing of our products. In addition, we compete with other
companies with respect to some of our marketed products as well as for
the discovery and development of new products. We believe that some of
our newer products, product candidates or new indications for existing
products, may face competition when and as they are approved and
marketed. Our products may compete against products that have lower
prices, established reimbursement, superior performance, are easier to
administer, or that are otherwise competitive with our products. In
addition, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates. We
cannot guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing products.
Our stock price may be affected by actual or perceived market
opportunity, competitive position, and success or failure of our
products or product candidates. Further, the discovery of significant
problems with a product similar to one of our products that implicate an
entire class of products could have a material adverse effect on sales
of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product
candidates are not approved by the U.S. Food and Drug Administration
(FDA), and no conclusions can or should be drawn regarding the safety or
effectiveness of the product candidates. Only the FDA can determine
whether the product candidates are safe and effective for the use(s)
being investigated. Further, the scientific information discussed in
this news release relating to new indications for our products is
preliminary and investigative and is not part of the labeling approved
by the FDA for the products. The products are not approved for
the investigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or effectiveness
of the products for these uses. Only the FDA can determine whether the
products are safe and effective for these uses. Healthcare professionals
should refer to and rely upon the FDA-approved labeling for the
products, and not the information discussed in this news release.
