Amgen to Appeal CHMP Opinion on Vectibix(R) (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer in Europe

Thousand Oaks, California (ots/PRNewswire) - Amgen
announced today that it has submitted a request to the European
Medicines Agency (EMA) for a re-examination of the negative opinion
issued in March by the Committee For Medicinal Products for Human Use
(CHMP) for the use of Vectibix in combination with chemotherapy for
patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Amgen believes that Vectibix in combination with chemotherapy
provides an important treatment option for patients with wild-type
KRAS mCRC. Amgen remains committed to patients with this aggressive
disease, for whom there are limited treatment options.

Data from studies 20050203 (PRIME) and 20050181 ('181') showed
that adding Vectibix to FOLFOX and FOLFIRI chemotherapy,
respectively, improved progression-free survival (PFS) versus
chemotherapy alone in patients with wild-type KRAS mCRC. Patients
taking this combination have a greater chance of living longer
without their disease getting worse. Additionally, the response rate
of Vectibix plus chemotherapy was higher than chemotherapy alone.
Though quantitatively greater, the improvement in median overall
survival did not achieve statistical significance in the Vectibix arm
of either trial.(i)(ii)

In general, adverse event rates were comparable across arms in
both studies, with the exception of known toxicities associated with
anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia.
Vectibix-related grade 3/4 infusion reactions were reported in less
than one percent of patients. In patients with mutant KRAS tumors,
outcomes were inferior for those receiving Vectibix plus FOLFOX
versus FOLFOX alone.(iii)(iv)

Vectibix is already approved and established in more than 30
countries outside of the United States (U.S.) as a monotherapy
treatment for patients with wild-type KRAS mCRC, when standard
chemotherapy is no longer effective. In the U.S., Vectibix received
accelerated approval in September 2006 as a monotherapy for the
treatment of patients with EGFR-expressing mCRC after disease
progression on or following fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens. Furthermore, use of
Vectibix is not recommended in patients whose tumors have KRAS
mutations in codon 12 or 13. In Japan and Israel, Vectibix is also
approved for use in combination with chemotherapy for patients with
wild-type KRAS mCRC.

About KRAS

Results from studies performed over the last 25 years indicate
that KRAS plays an important role in cell growth regulation. In mCRC,
EGFR transmits signals through a set of intracellular proteins. Upon
reaching the nucleus, these signals instruct the cancer cell to
reproduce and metastasize, leading to cancer progression.(v)
Anti-EGFR antibody therapies work by inhibiting the activation of
EGFR, thereby inhibiting downstream events that lead to malignant
signaling. However, in patients whose tumors harbor a mutated KRAS
gene, the KRAS protein is always turned "on," regardless of whether
the EGFR has been activated or therapeutically inhibited. KRAS
mutations occur in approximately 40-50 percent of mCRC
patients.(vi)(vii)

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide in
men and the second most common in women. In 2008, approximately 1.23
million cases of colorectal cancer were diagnosed globally.(viii) In
2008, there were an estimated 333,330 new cases of colorectal cancer
in the EU.(ix)

About Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
mCRC. Vectibix was approved in the U.S. in September 2006 as a
monotherapy for the treatment of patients with EGFR-expressing mCRC
after disease progression on or following fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix as a single agent for the treatment
of EGFR-expressing mCRC is based on progression-free survival (PFS).
Currently no data are available that demonstrate an improvement in
disease-related symptoms or increased survival with Vectibix.

Retrospective subset analyses of mCRC trials have not shown a
treatment benefit for Vectibix in patients whose tumors had KRAS
mutations in codon 12 or 13. Use of Vectibix is not recommended for
the treatment of colorectal cancer with these mutations.(x)

In December 2007, the European Medicine Agency (EMA) granted a
conditional marketing authorization for Vectibix as a monotherapy for
the treatment of patients with EGFR-expressing mCRC with non-mutated
(wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-,
and irinotecan-containing chemotherapy regimens.(xi) Vectibix has
been launched in more than 30 European Union countries, Russia,
Israel, Switzerland, Australia, Canada and Japan. Applications in the
rest of the world are pending.

Important European Product Safety Information

For full prescribing information please see the Summary of
Product Characteristics.

Vectibix is indicated as monotherapy for the treatment of
patients with EGFR-expressing, metastatic colorectal carcinoma (mCRC)
with nonmutated (wild-type) KRAS after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Vectibix is contraindicated in patients with a history of severe
or life-threatening hypersensitivity reactions to the product and in
patients with interstitial pneumonitis or pulmonary fibrosis.

Other common adverse events of special importance associated with
Vectibix and/or EGFR monoclonal antibody therapies include
dermatologic-related reactions, pulmonary complications, electrolyte
disturbances and infusion-related reactions (including rare reports
with fatal outcome). These events should be monitored carefully, see
Summary of Product Characteristics for information on appropriate
management of these adverse events. Acute renal failure has been
observed in patients who develop severe diarrhoea and dehydration.

Vectibix should not be used in combination with IFL [bolus
5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125
mg/m2)] or in combination with bevacizumab containing chemotherapy.

Vectibix should not be administered in combination with
oxaliplatin-containing chemotherapy to mCRC patients with mutant KRAS
tumours or for whom KRAS tumour status is unknown.

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, 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, bone disease, 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 http://www.amgen.com.

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CONTACT: Amgen
Carrie Deverell: +41-41-3690-308 (E.U. media)
Christine Regan: +1(805)447-5476 (U.S. media)
Arvind Sood: +1(805)447-1060 (investors)

(i) Douillard, JE et al. Randomized, Phase 3 Study (PRIME) of
Panitumumab with FOLFOX4 versus FOLFOX4 Alone as First-Line
Treatment in Patients With Previously Untreated Metastatic
Colorectal Cancer. J Clin Oncol 28. 2010.
(ii) Peeters, M et al. Randomized Phase III Study of Panitumumab With
Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared
With FOLFIRI Alone As Second-Line Treatment in Patients With
Metastatic Colorectal Cancer. J Clin Oncol 28, 2010.
(iii) Adverse event rates were comparable across arms with the exception
of known toxicities associated with anti-epidermal growth factor
receptor (EGFR) therapy such as rash, diarrhea and hypomagnesemia.
Vectibix-related grade 3 infusion reactions were reported for two
patients (less than 1 percent).
(iv) In general, adverse events rates were comparable across arms with
the exception of known toxicities associated with anti-epidermal
growth factor receptor (EGFR) therapy such as rash, diarrhea, and
hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were
reported in less than one percent of patients.
(v) Malumbres, M. and Barbacid, M. RAS oncogenes: the first 30 years.
Nature Reviews Cancer. 3:459-65, 2003.
(vi) Karapentis C, S. Snell, L, E. The Laboratory Assessment of KRAS
Mutation Status in Colorectal Cancer. Asia, Pacific Journal of
Oncology and Hematology. 2010.
(vii) Friday BB and Adjei AA. K-ras as a target for cancer therapy.
Biochim. Biophys. Acta 1756: 127-144, 2005.
(viii) Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM.
GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC
CancerBase No. 10. (http://globocan.iarc.fr) Lyon, France:
International Agency for Research on Cancer; 2010.
(ix) Ferlay J, Parkin DM, Steliarova-Foucher E Estimates of cancer
incidence and mortality in Europe in 2008.
(http://www.ncbi.nlm.nih.gov/pubmed/20116997) Eur J Cancer. 2010
Mar; 46(4):765-81. Epub 2010 Jan 29.
(x) Vectibix (panitumumab) [prescribing information]. Thousand Oaks,
Calif: Amgen; 2011.
(xi) Vectibix (panitumumab) SPC. Thousand Oaks, Calif: Amgen; 2011.

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