First Long-Term Data of a PCSK9 Inhibitor to be Featured in Clinical Science: Special Reports Session
THOUSAND OAKS, Calif., Nov. 12, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it will present new data on evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood1, at the upcoming American Heart Association (AHA) Scientific Sessions 2013, being held Nov. 16 – 20 in Dallas.
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 Tuesday, Nov. 19, at 4:51 p.m. CST.
"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 Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We hope the data we are accumulating from our Phase 3 clinical program for evolocumab will help advance care for patients who struggle to control high cholesterol and have an urgent unmet need."
Additionally, Amgen will highlight findings from long-term open-label data accumulated from patients in GAUSS (Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin intolerant Subjects) and MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels), two Phase 2 studies that evaluated evolocumab in patients with hyperlipidemia who cannot tolerate statins and as a stand-alone treatment, respectively.
Data presented on evolocumab will include:
- Randomized Comparison of the Safety, Tolerability, and Efficacy of Long-Term Administration of AMG 145 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)
Amgen will also host a webcast investor meeting at AHA on Tuesday, Nov. 19, at 7 p.m. CST. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate at the investor meeting to discuss data being presented at AHA.
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 Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
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 Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 binding to LDL receptors on the liver's surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.1
Amgen has obtained the issuance of two U.S. patents related to evolocumab: USP 8,030,457 and USP 8,563,698. These patents will expire in 2029 but some extension period may be available, subject to certain regulatory conditions and statutory provisions for patent term extension.
About PROFICIO: The Evolocumab Clinical Trial Program
PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations, is a large and comprehensive clinical trial program evaluating evolocumab. Phase 3 clinical trials for evolocumab are currently underway and build upon the Phase 2 studies.
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.
Amgen 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 since 1980, 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.
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 Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Nov. 12, 2013, and expressly disclaims any duty to update information contained in this news release.
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Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)
1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet 2003;34:154-156.