Amgen Announces Phase 2 Study Results for Brodalumab in Moderate to Severe Plaque Psoriasis Published in the New England Journal of Medicine

Brodalumab Moving Into Phase 3 for Moderate to Severe Psoriasis
 
THOUSAND OAKS, Calif., March 28, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that results from a Phase 2 trial evaluating the safety and efficacy of brodalumab (formerly AMG 827) in 198 patients with moderate to severe plaque psoriasis were published in the New England Journal of Medicine. The 12-week, dose-ranging study achieved its primary endpoint with the mean percentage improvement in psoriasis area and severity index (PASI) score higher in all brodalumab groups compared to placebo (p<0.001). Brodalumab is a human monoclonal antibody that selectively binds to and blocks signaling via the interleukin-17 (IL-17) receptor, thereby stopping the binding of several IL-17 family members associated with psoriasis. The majority of subjects treated with brodalumab 210 mg every other week achieved total clearance of their skin disease (PASI 100 of 62 percent).

PASI score is a measure of psoriatic plaque redness, scaling and thickness and the extent of involvement in each region of the body. Treatment efficacy is often measured by the reduction of PASI from baseline (i.e., a 75 percent reduction is known as PASI 75, a 90 percent reduction is known as PASI 90 and a PASI 100 is total clearance of skin disease).

"There are a variety of treatment options available to those living with psoriasis, yet these options are unable to help many patients achieve their therapeutic goals," explained Kim Papp, M.D., Ph.D., the study's lead author and director at Probity Medical Research, Ontario, Canada. "In this Phase 2 study, brodalumab showed a high level of response in patients with moderate to severe plaque psoriasis with a rapid onset of action within days. Based on these results, additional clinical trials are warranted to further assess the safety and efficacy of brodalumab."

Psoriasis affects approximately 125 million people worldwide and is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients have plaque psoriasis, which can cause painful and itchy red, scaly patches to appear on the skin.

Detailed Results
In this study, treatment with brodalumab every other week resulted in mean improvements in PASI scores of 85.9 percent (140 mg), 86.3 percent (210 mg) and 45.0 percent (70 mg) versus 16.0 percent with placebo (all p<0.001). A monthly dose of brodalumab at 280 mg was associated with a mean PASI improvement of 76 percent. Approximately 30 percent of patients in the placebo group had worsening psoriasis.

The study also evaluated secondary endpoints including PASI 75, PASI 90 and PASI 100, which indicate 75 percent, 90 percent and 100 percent reductions in patient PASI scores from baseline, respectively. In patients dosed with 140 mg of brodalumab, 77 percent achieved a 75 percent reduction in their PASI score, 72 percent achieved a 90 percent reduction and 38 percent experienced total clearance (PASI 100) (all p<0.001). In patients dosed with 210 mg of brodalumab, 82 percent achieved a 75 percent reduction, 75 percent achieved a 90 percent reduction and 62 percent experienced total clearance (PASI 100) (all p<0.001).  

The most commonly reported adverse events in the combined brodalumab groups were common cold (eight percent), upper respiratory tract infection (eight percent) and injection site redness (six percent). Two cases of grade three neutropenia were reported in the 210 mg brodalumab group.

Study Design
The study was a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging trial designed to assess the efficacy and safety of brodalumab in moderate to severe plaque psoriasis. Patients with a PASI >12 and affected body surface area >10 percent were randomized to receive brodalumab (70, 140 or 210 mg at day one and weeks 1, 2, 4, 6, 8 and 10 or 280 mg monthly) or placebo.

About Brodalumab (AMG 827)
Brodalumab (AMG 827) is a highly-selective human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes. 

Brodalumab is the only investigational treatment in development that blocks the IL-17 receptor, thereby blocking several of the IL-17 ligands at once from sending signals to the body. Currently, other agents in development seek to target the individual IL-17 ligands.  By stopping IL-17 ligands from binding with the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation and other ailments.

Brodalumab is currently being investigated for the treatment of psoriasis (Phase 2 and planned Phase 3), psoriatic arthritis (Phase 2) and asthma (Phase 2).

About Amgen
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Follow us on http://twitter.com/amgen.

Forward Looking Statements
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 most recent 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 March 28, 2012 and expressly disclaims any duty to update information contained in this news release.

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CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)

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Posted: March 2012

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