Amgen 2011 Annual Report Download - page 33

On July 15, 2011, we announced that the EC granted marketing authorization for XGEVA®for the
prevention of SREs (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in
adults with bone metastases from solid tumors. The timing of reimbursement authority approval of pricing in
individual EU countries will vary by country, which could follow the EC approval by many months. For
example, in August 2011, XGEVA®received reimbursement authority in Germany. The EC also granted
XGEVA®an additional year of data and market exclusivity in the EU since the indication was considered new
for denosumab and based on the significant clinical benefit of XGEVA®in comparison with existing therapies.
U.S. XGEVA®sales for the years ended December 31, 2011 and 2010, were $351 million and $8 million,
respectively.
Any products or technologies that are directly or indirectly successful in treating for the prevention of SREs
in patients with bone metastases from solid tumors could negatively impact XGEVA®sales.
The following table reflects currently marketed products that compete with XGEVA®. The table below and
the following discussion of competitor marketed products may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. & Europe Zometa®(1) Novartis
U.S. & Europe Aredia®(2) Novartis
(1) Novartis has indicated that patent protection on the active ingredient for Zometa®will expire in 2013 in the
United States and 2012 in other major markets. At such time, we expect that generic forms of zoledronic
acid may become commercially available and compete with Zometa®and XGEVA®.
(2) Novartis’s patent covering the use of Aredia®to treat tumor-induced hypercalcemia, osteolysis from
multiple myeloma and bone metastases from breast cancer expired in the United States in 2001. Following
the patent expiry, generic pamidronate, which competes with Aredia®and XGEVA®, became available
from other companies.
In addition, Bayer has a product candidate, alpharadin, in phase 3 clinical development for SREs in patients
with prostate cancer, that may compete with XGEVA®in the future.
Our outstanding material patents for denosumab are described in the following table.
Territory General Subject Matter Expiration(1)
U.S. RANKL antibodies; methods of interfering with RANK signaling 12/22/2017
U.S. Methods of treatment 11/11/2018
U.S. RANKL antibodies including sequences 2/19/2025
U.S. Nucleic acids encoding RANKL antibodies, and methods of
producing the same 11/11/2023
Europe RANKL antibodies 12/22/2017
Europe Medical use of RANKL antibodies 4/15/2018
Europe RANKL antibodies including epitope binding 2/23/2021
Europe RANKL antibodies including sequences 6/25/2022
(1) In some cases, these patents may be entitled to patent term extension in the United States or supplemental
protection in one or more countries in Europe and the length of any such extension will vary by country.
Marketing and Distribution
We maintain sales and marketing forces primarily in the United States, Europe and Canada to support our
currently marketed products. We have also entered into agreements with third parties to assist in the
commercialization and marketing of certain of our products in specified geographic areas. (See Business
Relationships.) Together with our partners, we market our products to healthcare providers, including physicians
or their clinics, dialysis centers, hospitals and pharmacies. We also market certain products directly to consumers
17