( BW)(AMGEN) Mimpara(R) (Cinacalcet) Receives Positive CHMP
Opinion for Extension of Marketing Authorisation in the European
Union; 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

    Business Editors/Health/Medical Writers

    ZUG, Switzerland--(BUSINESS WIRE)--April 25, 2008--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(R) (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(R) (cinacalcet) (also known as Sensipar(R) 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
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    --30--

    CONTACT: Amgen
             Marie Fay, +41 41 3690 339 (media)
             Arvind Sood, +1 805-447-1060 (investors)


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