Amgen 2009 Annual Report Download - page 25

clinical trial which will compare the effect of Vectibix®versus Erbitux®(cetuximab) on OS for chemorefractory
mCRC patients with wild-type KRAS tumors.
Worldwide Vectibix®sales for the years ended December 31, 2009, 2008 and 2007 were $233 million, $153
million and $170 million, respectively.
In July 2009, we announced that the FDA approved certain revisions to the U.S. prescribing information
(“PI”) for the EGFr class of antibodies, including Vectibix®. The INDICATIONS AND USAGE section of the PI
has been updated to include that 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 and that use of Vectibix®is not
recommended for the treatment of colorectal cancer with these mutations. The CLINICAL STUDIES section of
the PI has been updated to reflect results from retrospective analyses across seven randomized clinical trials with
agents in this class. This includes the first phase 3 analysis that showed mCRC patients with mutated KRAS tu-
mors do not respond to monotherapy with an EGFr-inhibiting antibody (the Vectibix®“408” trial). This decision
follows the FDA’s December 2008 ODAC meeting where the clinical utility of the KRAS gene as a predictive
biomarker in patients with mCRC treated with anti-EGFr antibody was discussed.
In 2009, we announced that the primary endpoint of extending progression-free survival (“PFS”) was met in
the phase 3 clinical trial evaluating Vectibix®in combination with FOLFOX as a first-line treatment in patients
with KRAS wild-type mCRC, while the secondary endpoint of OS was not met. In patients with mutated KRAS,
PFS was significantly inferior for patients who received Vectibix®as compared to patients that did not receive
Vectibix®. We also announced in 2009 that the co-primary endpoint of extending PFS was met in the phase 3
clinical trial evaluating Vectibix®in combination with FOLFIRI as compared to patients who received FOLFIRI
alone as a second line treatment in patients with KRAS wild-type mCRC, while the co-primary endpoint of OS
was not met. In patients with mutated KRAS, no difference was seen in PFS for patients who received Vectibix®
as compared to patients that did not receive Vectibix®. For more information, see “Research and Development
and Selected Product Candidates.” Based on the results of these studies, we are planning to file for regulatory
approval in the United States and EU for first- and second- line treatment in patients with KRAS wild-type
mCRC.
Our outstanding material patents for panitumumab are described in the table below.
Territory General Subject Matter Expiration
U.S. Human monoclonal antibodies EGFr 4/8/2020
Europe Human monoclonal antibodies EGFr 12/4/2022
Any products or technologies that are directly or indirectly successful in treating mCRC after disease pro-
gression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens
could negatively impact product sales for Vectibix®. The following table reflects companies and their currently
marketed products that primarily compete with Vectibix®in the United States and Europe. The table below of
competitor marketed products may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. Erbitux®Eli Lilly and Company (“Eli Lilly”)/ BMS
Europe Erbitux®Merck KGaA
Nplate®(romiplostim)
In August 2008, the FDA approved Nplate®, the first platelet producer for the treatment of thrombocytope-
nia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic
purpura (“ITP”). Nplate®, the first FDA approved peptibody protein, works by raising and sustaining platelet
counts. We were granted an exclusive license by KA to manufacture and market Nplate®in the United States, all
European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and cer-
tain countries in Central Asia, Africa and the Middle East. In February 2009, we announced that the European
Commission granted marketing authorization for Nplate®for the treatment of splenectomized adult chronic ITP
patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). In the EU, Nplate®may
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