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Amgen to Highlight New Evolocumab (AMG 145) Data at Upcoming American Heart Association Scientific Sessions 2013
Data from the Phase 2 OSLER (Open Label Study of Long TERm Evaluation Against LDL-C Trial) study, which evaluates the safety, tolerability and sustained efficacy of long-term administration of evolocumab and standard of care in more than 1,100 patients with high cholesterol, will be featured during a Clinical Science: Special Reports session on
"The Phase 2 OSLER study provides the first long-term 52-week data for a PCSK9 inhibitor in diverse patient populations with high cholesterol," said
Data presented on evolocumab will include:
- Randomized Comparison of the Safety, Tolerability, and Efficacy of
Long-Term Administration of AMG145 Versus Standard of Care in 1104 Patients: 52-Week Results from the OSLER Study
CS.03, Clinical Science: Special Reports,
Tuesday, Nov. 19, 4:51 - 5:01 p.m. CST(Ballrooms C1 & C2)
- Efficacy and Safety of Long-Term Treatment with AMG 145 Monotherapy
Abstract 12191, Abstract Poster Session,
Tuesday, Nov. 19, 3 - 4:30 p.m. CST(Hall F, Core 2, Poster Board: 2010)
- Efficacy and Tolerability of Long-Term Treatment With AMG 145 in Patients With Statin Intolerance
Abstract 12621, Abstract Poster Session,
Tuesday, Nov. 19, 3 - 4:30 p.m. CST(Hall F, Core 2, Poster Board: 2009)
Live audio of the investor meeting will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast of the conference, as with other selected presentations regarding developments in
About Evolocumab (AMG 145)
Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.2 Evolocumab, being developed by
The Phase 3 program includes 13 trials, with a combined planned enrollment of more than 28,000 patients. The Phase 3 studies will evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2), in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2), as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2), and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia.
Five studies of evolocumab will provide long-term safety and efficacy data, including the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) study, which will assess whether treatment with evolocumab compared to placebo reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease.
Additional information about clinical trials of evolocumab can be found at www.clinicaltrials.gov.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia.