Amgen 2013 Annual Report Download - page 7

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Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is committed to unlocking the potential of biology
for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins
by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology pioneer, Amgen has grown to be the world's largest independent biotechnology company,
has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
We were incorporated in California in 1980 and became a Delaware corporation in 1987. Amgen operates in one business segment: human therapeutics.
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Following is a summary of significant developments that occurred in 2013 and early 2014 affecting our business.
Acquisition
•In October 2013, we acquired Onyx Pharmaceuticals, Inc. (Onyx), a global biopharmaceutical company engaged in the development and
commercialization of innovative therapies for improving the lives of people with certain cancers. Onyx has a growing multiple myeloma franchise,
with Kyprolis® (carfilzomib) for Injection already approved in the United States (U.S.), and with oprozomib being evaluated in clinical trials for
patients with hematologic malignancies. In addition, Onyx has three partnered oncology assets: Nexavar ® (sorafenib) tablets (an Onyx and Bayer
HealthCare Pharmaceuticals, Inc. (Bayer) compound), Stivarga ® (regorafenib) tablets (a Bayer compound), and palbociclib (a Pfizer, Inc. (Pfizer)
compound). See Note 2, Business combinations to the Consolidated Financial Statements.
We believe there is a significant opportunity to grow Kyprolis ®. Ongoing studies to support and extend the position of Kyprolis ® in multiple
myeloma include:
•The FOCUS trial, which could support the European Union (EU) filing for the indication of relapsed/refractory multiple myeloma;
•The ASPIRE trial, which is the confirmatory trial for full U.S. approval as well as a registration-enabling study for relapsed multiple
myeloma in the United States and the EU;
•The ENDEAVOR trial, which compares Kyprolis® with Velcade® (bortezomib) in patients with relapsed multiple myeloma who have received
one to three prior therapies; and
•The CLARION trial, which compares Kyprolis ® with Velcade® in patients with newly diagnosed multiple myeloma.
Pipeline
Evolocumab (AMG 145)
•In December 2013 and January 2014, we announced results from five phase 3 lipid lowering clinical studies evaluating evolocumab as a
monotherapy, in combination with statin therapy, in heterozygous familial hypercholesterolemia, in statin-intolerant subjects, and in combination
with optimized lipid lowering therapy in a 52 week safety and efficacy study. All five of these studies met their primary endpoints.
In a separate phase 3 study of our devices for use in combination with evolocumab, 95 percent or greater of the 164 patients enrolled were able to
self-administer at least one full home administration of evolocumab 420 mg subcutaneously by one injection with an automated mini-doser or by
three injections with a standard spring-based autoinjector. Reductions in low-density lipoprotein cholesterol (LDL-C) were comparable with both
devices.
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