Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic Hepatitis C

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Human Genome Sciences Announces Albuferon® Meets Primary Endpoint in Phase 3

Trial in Chronic Hepatitis C

By: PR Newswire

Dec. 8, 2008 07:00 AM

- Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority

to Pegasys (peginterferon alfa-2a) in the ACHIEVE 2/3 trial in patients with

genotypes 2 and 3 chronic hepatitis C -

- Patients receiving 900-mcg Albuferon had comparable rates of serious adverse

events, severe adverse events and discontinuations due to adverse events, vs.

peginterferon alfa-2a -

ROCKVILLE, Md., Dec. 8 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc.

(Nasdaq: HGSI) today announced that Albuferon® (albinterferon alfa-2b) met its

primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in

ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon in combination with ribavirin

in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C

(p=0.0086). Albinterferon alfa-2b is being developed by HGS and Novartis under

an exclusive worldwide co-development and commercialization agreement entered

into in June 2006.

" We are pleased that Albuferon met its primary endpoint in the ACHIEVE 2/3

trial. These Phase 3 data show that the efficacy of Albuferon was comparable to

Pegasys, with half the injections, " said H. Watkins, President and Chief

Executive Officer, HGS. " We look forward to having the results of ACHIEVE 1, our

other Phase 3 trial of Albuferon, in March 2009. If ACHIEVE 1 is successful, we

believe Albuferon could become the market-leading interferon for the treatment

of chronic hepatitis C, and we expect that global marketing applications will be

filed by fall 2009. "

, M.D., Professor of Medicine, Medical Director of Liver

Transplantation, and Chief of the Hepatobiliary Disease Section, University of

Florida, said, " Chronic hepatitis C represents a significant unmet medical need.

These Phase 3 results suggest that albinterferon alfa-2b has the potential to

become an important new treatment option for patients with chronic hepatitis C.

Albuferon requires half as many injections as the pegylated interferons, and

clinical results to date suggest that it may offer comparable efficacy, with no

difference in clinically significant adverse events. The observed variation in

response by geography is an unexpected finding and requires further analysis. We

look forward to results from the ACHIEVE 1 trial, which is evaluating

albinterferon alfa-2b in the treatment of patients with genotype 1 hepatitis C. "

In the randomized, multi-center, active-controlled non-inferiority Phase 3

trial, 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C

were initially assigned to one of three treatment groups, including two groups

that received albinterferon alfa-2b once every two weeks at doses of 900-mcg or

1200-mcg, and an active control group that received peginterferon alfa-2a once

weekly at a dose of 180-mcg - with all patients receiving oral ribavirin daily

at 800-mg in two divided doses. In January 2008, a dose modification was made

and patients originally assigned to receive the 1200-mcg dose of albinterferon

alfa-2b had their dose reduced to 900-mcg albinterferon alfa-2b every two weeks.

The dose modification was recommended by the independent Data Monitoring

Committee (DMC) for the Albuferon Phase 3 trials, following their observation

during a routine review of unblinded data from both trials that serious

pulmonary adverse events were higher in the 1200-mcg Albuferon treatment group.

Following the dose modification, the study continued to follow all patients

randomized into the trial on an intention-to-treat (ITT) basis according to

their original dose assignment. The primary data analysis compares the 900-mcg

albinterferon alfa-2b treatment group to the peginterferon alfa-2a treatment

group. The trial included 24 weeks of treatment, and the primary efficacy

endpoint was non-inferiority to peginterferon alfa-2a, based on a comparison of

the rate of SVR, defined as undetectable viral load (HCV RNA < 10 IU/mL) at Week

48 (24 weeks following completion of treatment).

" We are encouraged that albinterferon alfa-2b met the primary efficacy endpoint

of non-inferiority to peginterferon alfa-2a in the ACHIEVE 2/3 study, " said

C. Stump, M.D., Executive Vice President, Research and Development, HGS.

" These data show that the rate of sustained virologic response was comparable

for the treatment group receiving the 900-mcg dose of albinterferon alfa-2b

every two weeks, versus the treatment group receiving the standard dose of

peginterferon alfa-2a once weekly. Importantly, the number of serious and severe

adverse events, including pulmonary adverse events, was also comparable. When we

have ACHIEVE 1 results in March, we will be in a position to assess the full

therapeutic potential of albinterferon alfa-2b. "

Key Findings from ACHIEVE 2/3

The topline ACHIEVE 2/3 results include the following key findings:

Treatment Group Receiving Albinterferon Alfa-2b 900-mcg Every Two Weeks, vs.

Treatment Group Receiving Peginterferon Alfa-2a 180-mcg Every Week

Based on an ITT analysis of the treatment group assigned to receive 900-mcg

albinterferon alfa-2b every two weeks, the topline results demonstrate that

albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to

peginterferon alfa-2a, with 79.8% (249/312) of patients achieving SVR in the

900-mcg albinterferon alfa-2b treatment group, vs. 84.8% (263/310) in the

peginterferon alfa-2a treatment group (p=0.0086 for non-inferiority).

By region, SVR rates were

North America: 82.5% (85/103) for 900-mcg albinterferon alfa-2b, vs. 81.5%

(88/108) for peginterferon alfa-2a;

Asia: 79.8% (75/94) for 900-mcg albinterferon alfa-2b, vs. 95.5% (85/89) for

peginterferon alfa-2a;

Europe: 78.1% (64/82) for 900-mcg albinterferon alfa-2b, vs. 81.7% (67/82) for

peginterferon alfa-2a;

Other regions: 75.8% (25/33) for 900-mcg albinterferon alfa-2b, vs. 74.2%

(23/31) for peginterferon alfa-2a.

Patients receiving 900-mcg albinterferon alfa-2b had comparable rates of serious

adverse events, severe adverse events, and discontinuations due to adverse

events, vs. peginterferon alfa-2a.

The incidence of severe and/or serious adverse events was comparable between the

two groups, with 17.3% (54/313) in the albinterferon alfa-2b 900-mcg treatment

group, vs. 17.5% (54/309) in the peginterferon alfa-2a treatment group.

The incidence of severe and/or serious pulmonary adverse events was also

comparable between these groups: severe and/or serious pulmonary infections were

0.6% (2/313) for 900-mcg albinterferon alfa-2b, vs. 0.6% (2/309) for

peginterferon alfa-2a; and severe and/or serious respiratory, thoracic or

mediastinal disorders were 1.0% (3/313) for 900-mcg albinterferon alfa-2b, vs.

1.3% (4/309) for peginterferon alfa-2a.

Overall, adverse events observed were those typically associated with interferon

therapy, and the rate of discontinuations due to adverse events was comparable:

4.8% (15/313) for 900-mcg albinterferon alfa-2b, vs. 3.6% (11/309) for

peginterferon alfa-2a.

Treatment Group Originally Randomized to Receive Albinterferon Alfa-2b 1200-mcg

Every Two Weeks and Reduced to 900-mcg Following January 2008 Dose Modification,

vs. Treatment Group Receiving Peginterferon Alfa-2a 180-mcg Every Week

Due to the dose modification announced in January 2008, patients in the

treatment group originally randomized to receive albinterferon alfa-2b 1200-mcg

every two weeks had their dose modified to 900-mcg albinterferon alfa-2b every

two weeks. All patients had completed at least 12 weeks of treatment at the time

of the dose modification. Data from all three treatment groups in the ACHIEVE

2/3 study were analyzed according to the original dose assignment. The following

topline results for the treatment group originally randomized to receive

1200-mcg albinterferon alfa-2b every two weeks did not impact the primary

analysis comparing the 900-mcg albinterferon alfa-2b treatment group to the

peginterferon alfa-2a treatment group.

Based on an ITT analysis of results for the treatment group originally

randomized to receive 1200-mcg albinterferon alfa-2b every two weeks, 80.0%

(248/310) of patients in this treatment group achieved SVR, vs. 84.8% (263/310)

in the peginterferon alfa-2a treatment group, which statistically demonstrated

non-inferiority (p=0.0059).

The incidence of severe and/or serious adverse events was comparable between the

two groups, with 16.8% (52/310) in the treatment group originally randomized to

receive 1200-mcg albinterferon alfa-2b every two weeks, vs. 17.5% (54/309) in

the peginterferon alfa-2a treatment group.

The incidence of severe and/or serious pulmonary adverse events was also

comparable between these groups: severe and/or serious pulmonary infections were

1.3% (4/310) in the treatment group originally randomized to receive 1200-mcg

albinterferon alfa-2b, vs. 0.6% (2/309) in the peginterferon alfa-2a treatment

group; severe and/or serious respiratory, thoracic or mediastinal disorders were

1.6% (5/310) in the treatment group originally randomized to receive 1200-mcg

albinterferon alfa-2b, vs. 1.3% (4/309) in the peginterferon alfa-2a treatment

group.

Overall, adverse events observed were those typically expected with interferon

therapy. The incidence of discontinuations due to adverse events was 5.5%

(17/310) in the treatment group originally randomized to receive 1200-mcg

albinterferon alfa-2b every two weeks, vs. 3.6% (11/309) in the peginterferon

alfa-2a treatment group.

About Albinterferon Alfa-2b (Albuferon)

Albinterferon alfa-2b is a novel, longer-acting form of interferon alfa that was

created using the proprietary HGS albumin-fusion technology. Human albumin is

the most prevalent naturally occurring blood protein in the human circulatory

system, persisting in circulation in the body for approximately 19 days.

Research has shown that genetic fusion of therapeutic proteins to human albumin

decreases clearance and prolongs the half-life of the therapeutic proteins.

Albuferon results from the genetic fusion of human albumin and interferon alfa.

Albuferon is being developed by HGS and Novartis for the treatment of chronic

hepatitis C under an exclusive worldwide co-development and commercialization

agreement entered into in June 2006. HGS and Novartis will co-commercialize

Albuferon in the United States and will share clinical development costs, U.S.

commercialization costs and U.S. profits equally. Novartis will be responsible

for commercialization in the rest of the world and will pay HGS a royalty on

those sales. Clinical development, commercial milestone and other payments to

HGS could total as much as $507.5 million, including $132.5 million received to

date.

About Hepatitis C

Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It

is estimated that as many as 170 million people worldwide are infected with

hepatitis C virus. This includes nearly four million people in the United

States. When detectable levels of HCV persist in the blood for at least six

months, a person is diagnosed with chronic hepatitis C. Hepatitis C virus can

cause serious liver disease, leading to cirrhosis, primary liver cancer and even

death.

Conference Call

HGS management will hold a conference call to discuss this announcement today at

8:15 AM Eastern. Investors may listen to the call by dialing 888-215-6982 or

913-312-0389, passcode 7154642, five to 10 minutes before the start of the call.

A replay of the conference call will be available within a few hours after the

call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-

457-0820, confirmation code 7154642. Today's conference call also will be

webcast and can be accessed at www.hgsi.com. Investors interested in listening

to the live webcast should log on before the conference call begins to download

any software required. Both the audio replay and the archive of the conference

call webcast will remain available for several days