Amgen 2009 Annual Report Download - page 24

Our outstanding material patents for cinacalcet are described in the table below.
Territory General Subject Matter Expiration
U.S.(1) Calcium receptor-active molecules 10/23/2015
U.S.(1) Calcium receptor-active molecules 12/14/2016
U.S.(1) Methods of treatment 12/14/2016
Europe(2) Calcium receptor-active molecules 10/23/2015
(1) An application for patent term extension has been submitted and is currently pending in the United States.
(2) In some cases, this European patent may also be entitled to supplemental protection in one or more countries
in Europe and the length of any such extension will vary by country.
Any products or technologies that are directly or indirectly successful in treating secondary hyper-
parathyroidism in patients with CKD on dialysis and/or hypercalcemia in patients with parathyroid carcinoma
could negatively impact product sales of Sensipar®/Mimpara®.
The following table reflects companies and their currently marketed products that primarily compete with
Sensipar®in the United States and Mimpara®in Europe in the nephrology segment for patients with CKD on
dialysis. The table and discussion below of competitor marketed products and potential competitor products 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 Inc
U.S. & Europe Zemplar®Abbott
U.S. & Europe Renagel®Genzyme
U.S. & Europe Renvela®Genzyme
U.S. & Europe PhosLo®/Rephoren®Fresenius Medical Care AG & Co. KGaA
(“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 Pharmaceuticals USA, Inc. and Teva Pharmaceutical
(together defined as “Teva”) and Barr Pharmaceuticals Inc. (“Barr”) for infringement of four Sensipar®patents.
The lawsuit is based on the Abbreviated New Drug Application filed by Teva and Barr which seeks approval to
market generic versions of Sensipar®. (See Note 20, “Contingencies and commitments” to the Consolidated Fi-
nancial Statements.) These generic versions could compete with Sensipar®in the future.
Vectibix®(panitumumab)
Vectibix®is our registered trademark for our first fully human monoclonal antibody for the treatment of pa-
tients 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 sig-
naling and is over-expressed in many human cancers. Vectibix®is a fully human monoclonal antibody that binds
with high affinity to EGFrs and interferes with signals that might otherwise stimulate growth and survival of the
cancer cell. The goal of developing fully human monoclonal antibodies is to offer effective targeted therapies
with lessened risk of immune response against these agents. We acquired full ownership of Vectibix®with our
acquisition of Abgenix, Inc. (“Abgenix”) in April 2006 and Vectibix®received FDA approval in September
2006. 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 after failure of standard chemo-
therapy regimens was received in December 2007 and is reviewed annually by the CHMP. In December 2008
and 2009, the conditional marketing authorization was renewed with an additional specific obligation to conduct
a clinical trial in the existing approved indication. In 2009, the CHMP approved the protocol for this additional
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