Amgen 2009 Annual Report Download - page 20

Our outstanding material patents for Epoetin alfa are described in the table below.
Territory General Subject Matter Expiration
U.S. Process of making erythropoietin 8/15/2012
U.S. Product claims to erythropoietin 8/20/2013
U.S. Pharmaceutical compositions of erythropoietin 8/20/2013
U.S. Cells that make certain levels of erythropoietin 5/26/2015
Amgen and Roche reached a settlement of litigation in December 2009, and on December 22, 2009, the U.S.
District Court for the District of Massachusetts entered final judgment and a permanent injunction against Roche
prohibiting Roche from infringing our patents. The judgment was accompanied by Roche’s admission that our
five patents involved in the lawsuit are valid, enforceable and infringed by Roche’s Peg-EPO, and by us allowing
Roche to begin selling Peg-EPO in the United States in mid-2014 under terms of a limited license agreement.
Peg-EPO has been approved by the FDA for the treatment of anemia associated with CKD.
Any products or technologies that are directly or indirectly successful in addressing anemia associated with
CRF could negatively impact product sales of EPOGEN®. 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 in the United States from those product candidates noted in the Aranesp®sec-
tion above that may be used in dialysis.
Neulasta®(pegfilgrastim)/NEUPOGEN®(Filgrastim)
Neulasta®is our registered trademark for a pegylated protein, based on the Filgrastim molecule, that se-
lectively stimulates production of certain white blood cells known as neutrophils. Neutrophils defend against
infection. NEUPOGEN®is our registered trademark for our recombinant-methionyl human G-CSF, a protein that
selectively stimulates production of neutrophils. Treatments for various diseases and diseases themselves can re-
sult in extremely low numbers of neutrophils, a condition called neutropenia. Myelosuppressive chemotherapy,
one treatment option for individuals with certain types of cancers, targets cell types that grow rapidly, such as
tumor cells. Normal cells that divide rapidly, such as those in the bone marrow that become neutrophils, are also
vulnerable to the effects of cytotoxic chemotherapy, resulting in neutropenia with an increased risk of severe in-
fection. Very often, neutropenia is the dose limiting side effect of chemotherapy and can thus be responsible for a
reduction in the amount of chemotherapy that can be administered safely. Such reductions in chemotherapy dose
can compromise the effectiveness of chemotherapy on the cancer it is being used to treat, with the result of a
higher treatment failure rate. As mentioned above, the pegfilgrastim molecule is based on the Filgrastim mole-
cule. A polyethylene glycol molecule (“PEG”) is added to enlarge the Filgrastim molecule, thereby extending its
half-life and causing it to be removed more slowly from the body. Because pegfilgrastim is eliminated through
binding to its receptor on neutrophils and their precursors, pegfilgrastim remains in the circulation until neu-
trophil recovery has occurred. This neutrophil-mediated clearance allows for administration as a single dose per
chemotherapy cycle, compared with NEUPOGEN®, which requires more frequent dosing. Neulasta®and
NEUPOGEN®are prescribed more frequently in the curative setting, in which myelosuppressive chemotherapy
is administered with the intent to cure cancer, rather than in the palliative setting, in which myelosuppressive
chemotherapy is administered to treat other complications of cancer by managing tumor growth.
We were granted an exclusive license to manufacture and market Neulasta®and NEUPOGEN®in the Unit-
ed States, Europe, Canada, Australia and New Zealand under a licensing agreement with KA (see “Business
Relationships — Kirin Holdings Company, Limited”).
We market Neulasta®and NEUPOGEN®primarily in the United States and Europe. Filgrastim is also mar-
keted under the brand name GRANULOKINE®in Italy. Neulasta®was initially launched in the United States
and Europe in 2002 and is indicated for reducing the incidence of infection associated with chemotherapy-
induced neutropenia in cancer patients with non-myeloid malignancies. Administration of Neulasta®in all cycles
of chemotherapy is approved for patients receiving myelosuppressive chemotherapy associated with at least a
17% risk of febrile neutropenia. NEUPOGEN®was initially launched in the United States and Europe in 1991.
NEUPOGEN®is indicated for reducing the incidence of infection as manifested by febrile neutropenia for
8