(Adds details on drug, rival drugs, new treatment approach)
By Ransdell Pierson
Aug 21 An experimental new psoriasis treatment
from Eli Lilly and Co proved superior to Amgen Inc's
blockbuster Enbrel, drawing it closer to a potential
marketing battle with new products being developed by Amgen and
Based on favorable results from Phase III trials, Lilly said
Thursday it would seek marketing approval in the first half of
2015 for its drug ixekizumab for patients with
moderate-to-severe plaque psoriasis.
Cowen and Company analysts have forecast that ixekizumab, if
approved, could generate annual sales for Lilly of $600 million
by 2020. That would make it a mid-sized product for the company,
which has annual sales of about $20 billion.
Lilly needs new drugs to restore earnings growth, as profits
have dropped for several years due to the expiration of patents
on big products.
Like rival injectable drugs being tested by Amgen and
Novartis, Lilly's treatment works by blocking an
inflammation-causing protein called IL-17, deemed to be a major
culprit in the skin disease.
Enbrel, Amgen's older drug, is the most widely prescribed
treatment for psoriasis and works by blocking a different
protein, called tumor necrosis factor.
After 12 weeks, patients treated with ixekizumab had
significantly greater clearance of raised skin patches that are
a hallmark of psoriasis, compared with those who took placebos
or Enbrel (etanercept) in the large trials, Lilly said.
In all three studies, patients received either a placebo or
ixekizumab every two or four weeks, for three months. In two of
those studies, called UNCOVER-2 and 3, patients could receive
Enbrel twice weekly. In UNCOVER-1, those responding to treatment
continued to take either placebos or ixekizumab for up to 60
Among patients treated with Lilly's drug, 78 to 90 percent
experienced at least a 75 percent reduction of skin plaque at 12
weeks, based on a standard scale of psoriasis area and severity.
Moreover, some 31 to 41 percent achieved clear skin. That
compared with 5 to 7 percent of those treated with Enbrel in the
UNCOVER-2 and 3 studies. In the UNCOVER-1 study, high levels of
effectiveness were maintained through 60 weeks of treatment.
The overall rate and severity of side effects for ixekizumab
were similar to those seen for Enbrel, including stuffy nose and
reactions at the injection site, Lilly said.
Novartis' treatment against IL-17, secukinumab, recently met
all its primary and secondary goals in late-stage trials,
showing superiority to Enbrel in one study.
Amgen and its partner AstraZeneca Plc in May
reported favorable results for their anti-IL-17 drug, called
brodalumab, in a late-stage trial.
Psoriasis is a chronic autoimmune disease in which the
growth cycle of skin cells is accelerated.
The most common form, plaque psoriasis, appears as raised,
red patches covered with a silvery white buildup of dead skin
cells. About 17 percent of an estimated 125 million psoriasis
patients worldwide have moderate-to-severe plaque psoriasis.
Lilly shares were little changed in afternoon trading.
(Additional reporting by Natalie Grover in Bangalore; Editing
by Bernadette Baum)