Amgen 2011 Annual Report Download - page 28

Any products or technologies that are directly or indirectly successful in addressing anemia associated with
renal failure could negatively impact EPOGEN®sales. In the United States, as noted above, EPOGEN®and
Aranesp®compete with each other, primarily in the U.S. hospital dialysis clinic setting. In addition, EPOGEN®
could face additional competition from those products noted in the Aranesp®section above that may be used in
dialysis in the United States.
Other Marketed Products
Our other marketed products include Sensipar®/Mimpara®(cinacalcet), Vectibix®(panitumumab), Nplate®
(romiplostim), Prolia®(denosumab) and XGEVA®(denosumab).
Sensipar®/Mimpara®(cinacalcet)
Sensipar®is our registered trademark in the United States and Mimpara®is our registered trademark in
Europe for cinacalcet, our small molecule medicine used in treating CKD patients on dialysis who produce too
much parathyroid hormone (PTH), a condition known as secondary hyperparathyroidism. In 2004, Sensipar®/
Mimpara®was approved in the United States and Europe for the treatment of secondary hyperparathyroidism in
CKD patients on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma. In 2008,
Mimpara®was approved in Europe for the reduction of hypercalcemia in patients with primary
hyperparathyroidism (PHPT) where a parathyroidectomy is not clinically appropriate or is contraindicated. In
2011, Sensipar®was approved in the United States for the treatment of severe hypercalcemia in patients with
PHPT who are unable to undergo parathyroidectomy. We market Sensipar®primarily in the United States and
Mimpara®primarily in Europe.
As previously discussed, CMS’s Final Rule on Bundling in Dialysis became effective on January 1, 2011
and provides a single payment for all dialysis services. Oral drugs without intravenous equivalents, such as
Sensipar®and phosphate binders, will continue to be reimbursed separately under the Medicare Part D benefit
until 2014 when they will be reimbursed under the bundled payment system. Inclusion in the bundled payment
system may reduce utilization of these oral drugs and have a material adverse impact on Sensipar®sales. (See
Reimbursement.)
The phase 3 EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (E.V.O.L.V.E™)
trial, initiated in 2006, is a large (3,800 patient), multi-center, international, randomized, double-blind study to
assess the effects of Sensipar®/Mimpara®on mortality and cardiovascular morbidity in patients with CKD
undergoing maintenance dialysis. The E.V.O.L.V.E™ study completed enrollment in January 2008 and we
anticipate data from the study in 2012.
Worldwide Sensipar®/Mimpara®sales for the years ended December 31, 2011, 2010 and 2009, were $808
million, $714 million and $651 million, respectively.
Our outstanding material patents for cinacalcet are described in the following table.
Territory General Subject Matter Expiration
U.S. Calcium receptor-active molecules including species 10/23/2015
U.S. Calcium receptor-active molecules 3/8/2018
U.S. Methods of treatment 12/14/2016
Europe(1) Calcium receptor-active molecules 10/23/2015
(1) 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
hyperparathyroidism in patients with CKD on dialysis and/or hypercalcemia in patients with parathyroid
carcinoma could negatively impact Sensipar®/Mimpara®sales.
12