Albuferon Quality-Of-Life Reported

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Albuferon Quality-Of-Life Reported

HUMAN GENOME SCIENCES REPORTS POSITIVE INTERIM QUALITY-OF-LIFE DATA

FROM PHASE 2B TRIAL OF ALBUFERONâ„¢ WITH RIBAVIRIN IN TREATMENT-

NAÃVE HEPATITIS C PATIENTS

- Albuferon associated with fewer missed work days and better patient-

reported quality-of-life scores than pegylated interferon through

Week 12 -

Announcement from Human Genome Sciences

ROCKVILLE, land - October 16, 2006 - Human Genome Sciences, Inc.

(Nasdaq: HGSI) today reported 12-week interim quality-of-life results

from a Phase 2b clinical trial to evaluate the efficacy, safety and

impact on health-related quality of life of Albuferonâ„¢ in

combination with ribavirin in patients with genotype 1 chronic

hepatitis C (HCV) who are naïve to interferon alpha-based treatment

regimens. The interim results demonstrate that all Albuferon

treatment groups consistently performed favorably through Week 12

compared to the pegylated interferon alpha treatment group, based on

patient-reported disability days and health-related quality of life

as measured by the SF-36 health survey. The data were presented over

this past weekend at the annual Australian Gastroenterology Week in

Adelaide.

“Health-related quality-of-life issues, including lost days of work

and normal activity, pose a significant challenge for patients

undergoing treatment for chronic hepatitis C,†said Pianko,

M.D., F.R.A.C.P., Ph.D., Associate Professor of Medicine, Monash

University (Melbourne, Australia). “Interim results of the current

study suggest that Albuferon may have the potential to offer a

therapeutic alternative with less impairment of health-related

quality of life, and fewer disability days, compared with the current

standard of care, with at least comparable safety and efficacy. We

look forward to continuing the evaluation of Albuferon to determine

its appropriate role in the treatment of hepatitis C.â€

“Through Week 12 of the Phase 2b study, patients in the Albuferon

treatment groups recorded fewer missed work days and, based on the SF-

36 health assessment, reported better quality of life than patients

in the pegylated interferon treatment group,†said C. Stump,

M.D., Executive Vice President, Drug Development, HGS . “This

result was observed in both the physical and mental component summary

measures, as well as in the 8 individual domain scores. The SF-36

results in mental health suggest significantly less impairment of

psychological well-being across the Albuferon treatment groups.â€

About the Albuferon Phase 2B 12-Week Quality-of-Life Results

Albuferon treatment groups recorded fewer disability days and

reported less impairment of health-related quality of life through

Week 12 of the Phase 2b study than patients in the pegylated

interferon treatment group. The 900-mcg Albuferon dose administered

at two-week intervals was associated with 75% fewer disability days,

and the 1200-mcg Albuferon doses administered at two-week and four-

week intervals were associated with 25% fewer disability days.

Through Week 12, b ased on the SF-36 health assessment, patient-

reported outcomes showed that the Albuferon treatment groups

consistently performed favorably compared to PEGASYS in both the

physical and mental component summary measures and in the 8

individual domain scores. SF-36 results in the mental health domain

demonstrated significantly less impairment of psychological well-

being across the Albuferon treatment groups (p=0.002 vs. PEGASYS). Of

the four treatment arms in the Phase 2b study, the 900-mcg Albuferon

dose administered once every two weeks was significantly associated

with the least negative impact on mental and physical function,

bodily pain, vitality, social functioning, and mental health domains,

while maintaining efficacy and safety at least comparable to

pegylated interferon alpha. Less worsening of health-related quality

of life also was observed in the treatment arms receiving 1200-mcg

Albuferon doses administered at two-week and four-week intervals,

respectively, compared to the pegylated interferon alpha treatment

group, with clinically meaningful differences observed in bodily

pain, mental health and social functioning.

Health-related quality of life was assessed using the Short Form 36

(SF-36) health survey. SF-36 is a patient-reported outcomes

instrument, consisting of 36 questions used to measure the health

status of patients with chronic hepatitis C. The 36 questions result

in an 8-scale health profile including: physical function, physical

role limitations, vitality, general health perceptions, pain, social

function, emotional role limitations, and mental health. Summaries of

the combined physical and mental component measures were also used in

the assessment.

About the Albuferon Phase 2B Trial Design

Data are available through Week 12 on 458 patients enrolled in the

randomized, open-label, multi-center, active-controlled, dose-ranging

study, which is being conducted in Australia, Canada, Czech Republic,

France, Germany, Israel, Poland and Romania. Patients were enrolled

and randomized into four treatment groups, three of which receive

subcutaneously administered Albuferon (900 mcg at two-week intervals,

1200 mcg at two-week intervals, and 1200 mcg at four-week intervals).

The fourth treatment group serves as the active control group and

receives 180-mcg doses of subcutaneously administered peginterferon

alfa-2a (PEGASYS) once every week. All patients receive oral daily

ribavirin. The primary efficacy endpoint of the Phase 2b study is

sustained virologic response (SVR), defined as undetectable virus 24

weeks after completion of 48 weeks of treatment. The secondary

endpoints include early virologic response at Week 12 (EVR12), and

safety and health-related quality of life at Weeks 12, 24 and 48.

About Albuferon

Albuferon is a novel, long-acting form of interferon alpha, which was

created by HGS using the Company's proprietary albumin fusion

technology. This technology enables scientists to improve the

pharmacological properties of therapeutic proteins by fusing the gene

that expresses human albumin to the gene that expresses the active

protein. Albuferon results from the genetic fusion of human albumin

and interferon alpha 2b. Recombinant interferon alpha is approved for

the treatment of hepatitis C, hepatitis B and a broad range of

cancers.

Albuferon is being developed by HGS and Novartis under an exclusive

worldwide development and commercialization agreement entered into in

June 2006.