Amgen 2007 Annual Report Download - page 38

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In addition, a number of companies have cytokine inhibitors in development, including GlaxoSmithKline
plc (“GlaxoSmithKline”), Pfizer Inc. (“Pfizer”), Repligen Corporation and Taisho Pharmaceutical Co., Ltd.,
which may compete with ENBREL. On December 4, 2007, J&J filed a BLA with the FDA and a market author-
ization application (“MAA”) with the EMEA for CNTO 1275 (ustekinumab) to treat adults with moderate to
severe plaque psoriasis. On February 4, 2008, the FDA accepted the BLA for review. J&J is also developing
CNTO 148 (golimumab) for the treatment of rheumatoid arthritis. Roche filed a BLA for its rheumatoid arthritis
candidate Actemra (tocilizumab) on November 21, 2007. Abbott is developing ABT-874, which is a psoriasis
drug. UCB has partnered with Nektar Therapeutics to develop Cimzia®(PEGylated anti-TNF) for the treatment
of rheumatoid arthritis and Crohn’s disease. On February 6, 2008, the FDA agreed to accept, for filing and re-
view, a BLA for Cimzia®.
Oncology
Any products or technologies that are directly or indirectly successful in treating mCRC after disease pro-
gression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens
could negatively impact product sales for Vectibix™. In October 2006, Vectibix™ was launched in the United
States. In December 2007, the European Commission granted a conditional marketing authorization for Vecti-
bix®in the EU. In early 2008, we launched Vectibix®in certain EU countries.
Amgen Marketed Product Competitor Marketed Product Competitor
Vectibix™ — U.S. Erbitux®Imclone Systems Incorporated
(“Imclone”)/ BMS
Vectibix™ — International Erbitux®Merck KGaA
Product candidates
We are currently studying new product candidates, including denosumab and Nplate™, and currently mar-
keted products for new indications, including Vectibix™, which, if approved, we expect will enter into highly
competitive markets. If successful, these product candidates will face substantial competition from products cur-
rently marketed as well as those under development by other biotechnology and pharmaceutical companies. For
example, the bone loss setting, in which denosumab would compete, is currently comprised of three therapeutic
classes: bisphosphonates, selective estrogen receptor modulators and anabolic agents. Competitive intensity will
increase in the bone loss setting with the expected approval of new agents.
The following table reflects other companies and their currently marketed products that will primarily com-
pete with denosumab, if approved:
Amgen Product Candidate Competitor Marketed Product Potential Competitor
Denosumab FOSAMAX®Merck & Co., Inc. (“Merck”)
Denosumab Actonel®Procter & Gamble /Aventis
Denosumab Boniva®/Bonviva®Roche / GlaxoSmithKline
Denosumab Evista®Eli Lilly and Company (“Eli Lilly”)
Denosumab Forteo®/Forsteo™Eli Lilly
Denosumab Miacalcin®Novartis
Denosumab Zometa®Novartis
Denosumab Aredia®Novartis
Denosumab Aclasta®/Reclast®Novartis
Merck’s patent covering the use of FOSAMAX®to treat bone loss expired in the United States in February
2008. Following the patent expiry, generic aledronate became available from Teva Pharmaceutical Industries
Ltd. and is expected to be available from other companies. GlaxoSmithKline is in the development of PRO-
MACTA®, which is in phase 3, and may compete with Nplate™.
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