Abbott's Humira tops psoriasis treatment in study

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Abbott: Study finds psoriasis drug effective

Company says Phase III test finds Humira more than doubly effective than

regular treatment.

October 5 2006: 7:14 PM EDT

http://money.cnn.com/2006/10/05/news/companies/bc.health.abbott2.reut/index.htm

CHICAGO (Reuters) -- A late-stage study found Abbott Laboratories Inc.'s

rheumatoid arthritis drug Humira was more than twice as effective at

treating the extent and severity of psoriasis as the standard treatment,

meeting its main goal, the company said Thursday.

The Phase III study found 80 percent of patients with moderate-to-severe

psoriasis saw a 75 percent clearing of their symptoms after 16 weeks,

compared with 36 percent of patients reaching that level of benefit on the

standard treatment methotrexate.

Humira, one of Abbott's (Charts) best-selling products, works by blocking a

protein called tumor necrosis factor. The company expects to submit

applications with European and U.S. regulators in the first half of 2007

that would expand the drug's usage.

Psoriasis, a skin condition characterized by scaling and inflammation,

afflicts 125 million people worldwide. The study was presented at the

European Academy of Dermatology and Venereology Congress in Greece.

" Psoriasis is, in our view, the most important pipeline indication for

Humira, with market opportunity estimates ranging as high as $2 billion in

the Unites States alone, " said JP (Charts) analyst Weinstein.

Amgen Inc.'s (Charts) rheumatoid arthritis drug Enbrel and &

(Charts) rheumatoid arthritis drug Remicade have already received U.S.

marketing approval for the psoriasis.

Wyeth (Charts), which co-promotes Enbrel with Amgen in North America and has

exclusive marketing rights outside the United States, said Thursday it

expects annual sales of Enbrel outside North America to hit $3 billion by

2010.

Abbott said its study was the first head-to-head comparison between a

biologic agent and a standard systemic treatment.

The Abbott study involved 271 patients from eight European countries and

Canada. Patients were split into three treatment arms, with groups receiving

Humira injections, standard treatment with methotrexate or a placebo

treatment.

Abbott said patients experienced similar side effects to those treated with

Humira for other indications. Those included injection site reaction,

inflammation of the nose and pharynx, joint pain and headache.

JP 's Weinstein said Abbott's late-stage European study was the first

of two trials; results from a second U.S. trial should be presented in

February.

" While we do not expect the data to be as favorable as today's, we think the

aggregate data package on Humira should position it as best-in-class in

psoriasis, " he said.

Humira is approved for psoriatic arthritis and ankylosing spondylitis in

Europe and the United States and the company is studying it in other

autoimmune indications.

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Abbott's Humira tops psoriasis treatment in study

Last Update: 6:04 PM ET Oct 5, 2006

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CHICAGO (MarketWatch) -- Abbott Laboratories (ABT) said Wednesday that its

drug Humira performed better in a Phase III study than a standard treatment

for the skin disease psoriasis, a major potential market for Abbott.

The Abbott Park, Ill., company also reiterated that it plans to submit

applications with U.S. and European regulators in the first half of 2007

seeking permission to market Humira as a psoriasis treatment. The drug,

which Abbott has said could post more than $1.9 billion in sales this year,

is currently approved to treat rheumatoid arthritis, arthritis of the spine

and psoriatic arthritis - but not psoriasis itself.

Humira posted $1.4 billion in sales last year. Shares of Abbott traded

recently at $46.32, down 82 cents, or 1.7%.

The new Phase III data, presented at a medical conference in Greece, matched

Humira against a placebo and methotrexate - a standard drug used for years

to treat psoriasis - to see which treatment scored best after 16 weeks on a

standard scale of psoriasis treatment. The study showed that 80% of people

with moderate to severe psoriasis saw at least 75% improvement at 16 weeks,

more than doubling methotrexate's performance, Abbott said.

The study included 271 patients - in eight European countries and Canada -

and met its " primary efficacy endpoint " of reducing disease activity more

than methotrexate or a placebo. There is currently no cure for psoriasis, a

chronic autoimmune disease that affects about 125 million people worldwide.

About a quarter of patients experience moderate to severe disease symptoms,

Abbott said.

The company said the safety profile of the " Champion " study was consistent

with prior Humira studies. Adverse affects in more than 5% of Humira

patients including reaction at the injection site, hepatic events,

inflammation of the nose and pharynx, joint pain and headaches.

Humira is part of a class of treatments called tumor necrosis factor

antagonists, or anti-TNF. TNF is a substance believed to play a role in

inflammatory conditions.

Humira competitors include & 's (JNJ) Remicade and Enbrel,

which is co-marketed by Amgen Inc. (AMGN) and Wyeth (WYE). If approved for

psoriasis, Humira would join Enbrel and Remicade as approved treatments for

the disease - J & J announced last week that Remicade had gained U.S. Food and

Drug Administration approval for severe psoriasis treatment.

The results of the Champion study suggest that Humira " is likely to achieve

'best in class' status among the biologics, " RBC Capital Markets analyst

Phil Nalbone said in a research note Thursday. " At its peak - within roughly

three years of launch - we believe the psoriasis indication will represent

at least a $500 million annual sales opportunity for Abbott. "

Regulatory approval could come by late 2007 or early 2008, Nalbone said. He

forecast $2.03 billion in Humira sales this year, and $2.71 billion next

year.

RBC does not have an investment banking relationship with Abbott. A member

company of the firm or an affiliate has received compensation from Abbott

for non-banking services in the last 12 months.

Abbott will announce results in February from a significantly larger and

longer Phase III study of Humira for psoriasis treatment. That study is

based in the U.S.

Abbott recently announced that it has filed with U.S. and European

regulators seeking approval to market Humira for the treatment of moderate

to severe Crohn's disease, a serious and chronic intestinal inflammatory

disorder.

The company also plans to file with regulators next year seeking approval to

use Humira to treat juvenile rheumatoid arthritis, and is planning to

eventually seek approval for Humira as a treatment for ulcerative colitis,

another intestinal inflammatory disease.