Amgen to Appeal CHMP Opinion on Vectibix(TM) (Panitumumab)

Amgen (NASDAQ:AMGN) today issued the following statement:

Amgen has received notice from the European Medicines Agency
(EMEA) that the European Committee for Medicinal Products for Human
Use (CHMP) has adopted a negative opinion for Amgen's marketing
authorization application (MAA) for Vectibix(TM) (panitumumab) for
patients with metastatic colorectal cancer (mCRC) who have failed
chemotherapy.

In accordance with European regulations, Amgen intends to request
re-examination of the CHMP opinion through the appeal procedure.
Notwithstanding the CHMP's initial view, Amgen is confident that the
available data demonstrates that Vectibix improves progression-free
survival (PFS) for mCRC patients who have progressed on, or following
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens.

Vectibix is the first fully human IgG2 monoclonal antibody (MAb)
that targets the epidermal growth factor receptor (EGFr), a protein
that plays an important role in cancer cell signalling, a well
validated target in oncology. Vectibix was approved by the United
States Food and Drug Administration (FDA) in September 2006. The FDA
approval of Vectibix was based on a progression-free survival
endpoint.

About Vectibix

Vectibix is indicated in the United States for the treatment of
patients with epidermal growth factor receptor- (EGFr) expressing
metastatic colorectal cancer after disease progression on or following
fluoropyrimidine-, oxaliplatin-, and irinotecan- containing
chemotherapy regimens. The effectiveness of Vectibix for the treatment
of EGFr-expressing, metastatic colorectal carcinoma is based on
progression-free survival. Currently no data are available that
demonstrate an improvement in disease-related symptoms or increased
survival with Vectibix.

Important Product Safety Information

Dermatologic toxicities, related to Vectibix blockade of EGF
binding and subsequent inhibition of EGF receptor-mediated signaling
pathways, included but were not limited to dermatitis acneiform,
pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and
skin fissures. Dermatologic toxicities were reported in 89 percent of
patients treated with Vectibix and were severe in 12 percent of
patients. Severe dermatologic toxicities were complicated by
infection, including sepsis, septic death, and abscesses requiring
incisions and drainage. Vectibix may need to be withheld or
discontinued for severe dermatologic toxicities.

Severe infusion reactions occurred with Vectibix in approximately
1 percent of patients. Severe infusion reactions were identified as
anaphylactic reactions, bronchospasm, fever, chills, and hypotension.
Although fatal infusion reactions have not been reported with
Vectibix, they have occurred with other monoclonal antibody products.
Severe infusion reactions require stopping the infusion and possibly
permanently discontinuing Vectibix, depending on the severity and/or
persistence of the reaction.

About Amgen

Amgen discovers, develops 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 vital
medicines, visit www.amgen.com.

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