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AstraZeneca: Amgen and AstraZeneca announce positive results from phase 3 study of Brodalumab  (AMG 827) in patients with moderate-to-severe plaque psoriasis

Study evaluating novel investigational IL-17 receptor antibody meets
all primary and secondary endpoints

AstraZeneca and Amgen today announced that the Phase 3 AMAGINE-1TM
study evaluating brodalumab in patients with moderate-to-severe
plaque psoriasis met all primary and secondary endpoints for both
evaluated doses. Brodalumab is the only investigational treatment in
development that binds to the interleukin-17 (IL-17) receptor and
inhibits inflammatory signaling by blocking the binding of several
IL-17 ligands to the receptor. Primary endpoints were patients
achieving at least a 75 percent improvement from baseline in disease
severity at week 12, as measured by the Psoriasis Area Severity Index
(PASI 75), and patients achieving clear or almost clear skin at week
12 according to the static Physician Global Assessment (sPGA 0 or 1).

A significantly higher proportion of patients treated with brodalumab
achieved a PASI 75 response (primary endpoint), as well as PASI 90
and PASI 100 responses at week 12 (secondary endpoints) compared to
placebo. Results showed that 83.3 percent of patients in the 210 mg
group and 60.3 percent of patients in the 140 mg group achieved PASI
75 responses compared to placebo (2.7 percent). Results also showed
that 70.3 percent of patients in the 210 mg group and 42.5 percent of
patients in the 140 mg group achieved PASI 90 responses compared to
placebo (0.9 percent). Further, 41.9 percent of patients in the 210
mg group and 23.3 percent of patients in the 140 mg group achieved
PASI 100 responses compared to placebo (0.5 percent). Of the 661
patients enrolled in this study, 46 percent reported prior biologic
use and 28.7 percent weighed more than 100 kilograms (kg) at baseline
(mean weight for the study population was 90.8 kg).

A 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 PASI 100 is total clearance
of skin disease).

The most common adverse events that occurred during the
placebo-controlled period in the brodalumab group (more than 5
percent of participants) were nasopharyngitis, upper respiratory
tract infection and headache. Serious adverse events occurred in 1.8
percent of patients in the 210 mg group and 2.7 percent of patients
in the 140 mg group compared to 1.4 percent for placebo during the
placebo-controlled period.

"Data from the AMAGINE-1 study suggest that brodalumab may offer a new
level of efficacy for patients with moderate-to-severe plaque
psoriasis, a disease that affects more than 100 million people
globally," said Sean E. Harper, executive vice president of Research
and Development at Amgen. "This is the first read-out from our Phase
3 psoriasis clinical programme and we look forward to obtaining
additional Phase 3 data from our two head-to-head studies versus
ustekinumab later this year."

Psoriasis is a non-contagious chronic disease in which the immune
system causes skin cells to grow at an accelerated rate. Instead of
being shed, skin cells pile up, causing painful and itchy, red, scaly

"Moderate-to-severe plaque psoriasis is a serious disease, and despite
available treatments, there is still a significant need for more
effective therapies," said Briggs Morrison, executive vice president
of Global Medicines Development at AstraZeneca. "We are encouraged by
brodalumab's emerging profile and look forward to presenting the full
data in the appropriate scientific forum."

AMAGINE-1 is one of three Phase 3 studies designed to assess the
efficacy and safety of brodalumab in patients with moderate-to-severe
plaque psoriasis. AMAGINE-2 and AMAGINE-3 are designed to evaluate
the efficacy and safety of induction and maintenance regimens of
brodalumab at different dose schedules in patients with
moderate-to-severe plaque psoriasis compared to ustekinumab and

- ENDS -


AMAGINE-1 Study Design

AMAGINE-1 assessed the safety and efficacy of brodalumab given every
two weeks via subcutaneous injection at two doses (140 mg or 210 mg)
compared to placebo in patients with moderate-to-severe plaque
psoriasis. Another purpose of the study was to assess safety and
efficacy when patients treated with brodalumab, who responded to
treatment, began receiving placebo compared to the patients who
continued receiving brodalumab.

The Phase 3 study began with a 12-week, double-blind,
placebo-controlled induction phase. During this phase, patients were
randomised in a 1:1:1 ratio to receive 210 mg of brodalumab, 140 mg
of brodalumab or placebo every two weeks.

At week 12, patients originally randomised to receive treatment with
brodalumab who achieved clear or almost clear skin according to their
sPGA (0 or 1) were rerandomised 1:1 to receive placebo or continued
treatment with brodalumab at the current dose. Rerandomised patients
losing disease control were treated with their original brodalumab
dose. All patients originally randomised to placebo and any patient
not qualifying for rerandomisation (sPGA > 1) received 210 mg of
brodalumab every two weeks.

sPGA is a physician's rating of psoriasis severity at a given point in
time based on plaque, scaling and redness. A physician can rate a
patient's psoriasis as clear (0), almost clear (1), mild (2),
moderate (3), severe (4) or very severe (5).

About Brodalumab (AMG 827)

Brodalumab is a novel human monoclonal antibody that binds to the
interleukin-17 (IL-17) receptor and inhibits inflammatory signaling
by blocking the binding of several IL-17 ligands to the receptor. By
stopping IL-17 ligands from activating the receptor, brodalumab
prevents the body from receiving signals that may lead to
inflammation. The IL-17 pathway plays a central role in inducing and
promoting inflammatory disease processes. In addition to
moderate-to-severe plaque psoriasis (Phase 3), brodalumab is
currently being investigated for the treatment of psoriatic arthritis
(Phase 3) and asthma (Phase 2).

About the Amgen and AstraZeneca Collaboration

In April 2012, Amgen and AstraZeneca formed a collaboration to jointly
develop and commercialise five monoclonal antibodies from Amgen's
clinical inflammation portfolio. With oversight from joint governing
bodies, Amgen leads clinical development and commercialisation for
brodalumab (Phase 3 for moderate-to-severe plaque psoriasis and

psoriatic arthritis, Phase 2 for asthma) and AMG 557/MEDI5872 (Phase
1b for autoimmune diseases such as systemic lupus erythematosus).
AstraZeneca, through its biologics arm MedImmune, leads clinical
development and commercialisation for MEDI7183/AMG 181 (Phase 2 for
ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase 2
for Crohn's disease) and MEDI9929/AMG 157 (Phase 2 for asthma).

About Amgen

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.

For more information, visit and follow us on

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:


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2014 and expressly disclaims any duty to update information contained
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