Amgen 2010 Annual Report Download - page 23

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Our outstanding material patents for darbepoetin alfa are described in the following table.
Territory General Subject Matter Expiration
U.S. Glycosylation analogs of erythropoietin proteins 5/15/2024
Europe(1) Glycosylation analogs of erythropoietin proteins 8/16/2014
(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.
Our principal European patent relating to Epoetin alfa expired in December 2004. Although we do not market
EPOGEN»in Europe, upon expiration of this patent, some companies received approval to market products,
including biosimilars, that compete with Aranesp»in Europe, as further discussed below.
Any products or technologies that are directly or indirectly successful in addressing anemia associated with
chemotherapy and/or renal failure negatively impact Aranesp»sales. In the United States, Aranesp»competes with
EPOGEN», primarily in the U.S. hospital dialysis clinic setting. The following table reflects companies and their
currently marketed products that compete with Aranesp»in the United States and Europe in the supportive cancer
care and nephrology segments, unless otherwise indicated. The table and the following discussion of competitor
marketed products and products in development may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. PROCRIT»(1) Centocor(2)
Europe EPREX»/ERYPO»Janssen-Cilag(2)
Europe NeoRecormon»F. Hoffmann-La Roche Ltd. (“Roche”)
Europe Retacrit
TM
(3)/Silapo»(3) Hospira Inc.. (“Hospira”)/Stada
Arzneimittel AG
Europe Binocrit»(3)/Epoetin alfa
Hexal»(3)/Abseamed»(3)
Sandoz GmbH (“Sandoz”)/Hexal Biotech
Forschungs GmbH (“Hexal”)/Medice
Arzneimittel Pu
¨tter GmbH & Company
KG
Europe MIRCERA»(4) Roche
Europe Eporatio»/Biopoin»ratiopharm GmbH (“ratiopharm”)(5)/CT
Arztneimittel GmbH (“CT
Arztneimittel”)
(1) Aranesp»competes with PROCRIT»in the supportive cancer care and pre-dialysis settings.
(2) A subsidiary of J&J.
(3) Biosimilar product.
(4) Competes with Aranesp»in the nephrology segment only. Pursuant to a December 2009 settlement agreement
between Amgen and Roche, Roche is allowed to begin selling MIRCERA»in the United States in mid-2014
under terms of a limited license agreement. MIRCERA»has been approved by the FDA for the treatment of
anemia associated with CRF.
(5) A subsidiary of Teva Pharmaceutical Industries Ltd. (“Teva Pharmaceutical”).
In addition to competition from these marketed products, the following products in development could
compete with Aranesp»in the future:
• Affymax Inc. and Takeda Pharmaceutical Company Limited (“Takeda”) are co-developing peginesatide, an
ESA for the treatment of anemia in CRF patients on dialysis and they have announced plans to file for
regulatory approval in the United States in the second quarter of 2011.
• Reliance Life Sciences Pvt. Ltd. (“Reliance Life Sciences”) has an epoetin biosimiliar (Epostim) that they
filed for regulatory approval for in Europe.
7