Amgen 2011 Annual Report Download - page 29

The following table reflects companies and their currently marketed products that compete with Sensipar®
in the United States and with Mimpara®in Europe in the nephrology segment for patients with CKD on dialysis.
The table below and the following discussion of competitor marketed products and products in development may
not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. Hectorol®Genzyme Corporation (Genzyme)
U.S. Rocaltrol®Roche
U.S. Calcijex®Abbott
U.S. Calcium Acetate®Roxane Laboratories/Sandoz
U.S. & Europe Zemplar®Abbott
U.S. & Europe Renagel®Genzyme
U.S. & Europe Renvela®Genzyme
U.S. & Europe PhosLo®/Rephoren®Fresenius Medical Care
U.S. & Europe OsvaRen®Fresenius Medical Care
U.S. & Europe Fosrenol®Shire Pharmaceuticals Group Plc
On July 25, 2008, we filed a lawsuit against Teva and Barr Pharmaceuticals Inc. (Barr) for infringement of
four Sensipar®patents. The lawsuit was based on Abbreviated New Drug Applications filed by Teva and Barr
that sought approval to market generic versions of Sensipar®. Following trial, on January 7, 2011, the U.S.
District Court for the District of Delaware granted an injunction prohibiting Teva and Barr from commercializing
generic versions of Sensipar®in the United States until expiration of three of those patents. These generic
versions could compete with Sensipar®in the future.
Vectibix®(panitumumab)
Vectibix®is our registered trademark for panitumumab, our monoclonal antibody for the treatment of patients
with EGFr expressing mCRC after disease progression on, or following fluoropyrimidine-, oxaliplatin- and
irinotecan- containing chemotherapy regimens. EGFr is a protein that plays an important role in cancer cell
signaling and is over-expressed in many human cancers. Vectibix®binds with high affinity to EGFrs and interferes
with signals that might otherwise stimulate growth and survival of the cancer cell. We acquired full ownership of
Vectibix®with our acquisition of Abgenix, Inc. (Abgenix) in April 2006. In September 2006, Vectibix®received
FDA accelerated approval in the United States, based upon clinical trial data from a study demonstrating a
statistically significant improvement in progression-free survival and with the condition that Amgen conduct a
confirmatory trial to verify the clinical benefit of panitumumab through demonstration of an improvement in overall
survival. (See discussion of the ‘181 trial below.) In the EU, the conditional approval of Vectibix®as monotherapy,
for the treatment of patients with EGFr expressing metastatic colorectal carcinoma with non-mutated (wild-type)
KRAS genes after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens, was
received in December 2007 and is reviewed annually by the Committee for Medicinal Products for Human Use
(CHMP). Each year thereafter, the EU conditional marketing authorization was renewed with an additional specific
obligation to conduct a clinical trial in the approved monotherapy indication. In 2010, we began enrollment for this
additional clinical trial which compares the effect of Vectibix®versus Erbitux®(cetuximab) on overall survival for
chemorefractory mCRC patients with wild-type KRAS genes. KRAS is a protein found in all human cells. Some
colorectal cancers have mutations in the KRAS gene. Vectibix®has been shown to be ineffective in people whose
tumors had KRAS mutations in codon 12 or 13.
In 2009, we announced results from the ‘203 and ‘181 pivotal phase 3 trials evaluating Vectibix®in
combination with chemotherapy (FOLFOX or FOLFIRI) as a first- and second-line treatment for mCRC,
respectively. Both studies demonstrated that Vectibix®administered with chemotherapy significantly improved
progression-free survival in patients with wild-type KRAS mCRC. Additionally, both studies showed numeric
improvements in median overall survival in the same patient population. The numeric improvements in median
overall survival failed to achieve statistical significance. It was previously agreed with the FDA that the ‘181
study would serve as the confirmatory trial for establishing full approval for the mCRC indication.
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