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Enbrel is in Phase II clinical development for the treatment of

asthma as well as for the treatment of idiopathic pulmonary fibrosis.

According to Datamonitor Plc. analysts, Enbrel is among several novel

antifibrotic agents in clinical trials that offer new hope for major

advances in the treatment of idiopathic pulmonary fibrosis by

inhibiting the processes that lead to end-stage fibrosis. Idiopathic

pulmonary fibrosis is a progressive and lethal disease of elderly

patients for which current therapy is minimally effective.

To date, very few multicenter trials have been conducted in

idiopathic pulmonary fibrosis. Datamonitor analysts estimate,

however, that the promising antifibrotic drugs in Phase II/III

clinical trials could potentially bring relief to more than 200,000

sufferers and will create a new market estimated to be worth more

than $2 billion annually.

Idiopathic pulmonary fibrosis is a disease of unknown cause that

affects people 50 years old and older. A typical symptom cluster

includes shortness of breath, a chronic dry hacking cough, and chest

discomfort. Shortness of breath is usually the most prominent and

disabling symptom, although the cough may have a greater impact on a

patient's daily life in terms of decreased socialization.

The pathology of the disease is poorly understood, although current

thinking suggests that the disease is a disorder of wound healing, in

which progressive fibrosis gradually interferes with a persons

ability to breathe. Novel antifibrotic agents in clinical trials,

such as interferon-gamma 1b, pirfenidone, bosentan, and etanercept,

which inhibit the process of fibrosis, may prevent the fatal outcome

common in idiopathic pulmonary fibrosis patients.

There are estimated to be about 220,000 people in the United States,

Europe, and Japan that are affected by idiopathic pulmonary fibrosis,

with about 90,000 of these patients in the United States. These

figures are comparable to the prevalence of diseases such as chronic

myeloid leukemia. As a consequence of misdiagnosis and late

presentation, however, the actual number of diagnosed patients is

significantly lower.

The prevalence of idiopathic pulmonary fibrosis is expected to

increase drastically during the next 10 years due to the aging of the

population combined with improvements in diagnosis, according to

Shaun Falkingbridge, respiratory senior analyst, Datamonitor

(datamonitor.com).

" Patients have a five-year survival rate of 20%; lower than many

neoplastic diseases, including non-Hodgkin's lymphoma, colorectal

cancer, prostate cancer, and breast cancer, although to date very few

multicenter trials have been conducted in idiopathic pulmonary

fibrosis compared with diseases with a similar mortality, " Mr.

Falkingbridge says. " Enbrel has recently completed Phase II clinical

trials for idiopathic pulmonary fibrosis and is expected to reach the

market in 2009. "

MARY LOU