The total duration of therapy in ACHIEVE 1 will be 48 weeks, with 24 weeks of follow-up. The total duration of therapy in ACHIEVE 2/3 will be 24 weeks, with 24 weeks of follow-up.
Both phase III trials achieved their primary endpoints of non-inferiority to peginterferon alfa-2a (Pegasys). The data demonstrated that, with half as many injections, in the two pivotal trials, Albuferon achieved efficacy which was comparable to Pegasys with a positive safety profile. The two studies treated a combined total of 2255 treatment-naive patients.
The submission of global marketing applications for Albuferon is planned in fall 2009, following discussions with the FDA and other regulatory authorities.
Although no safety concerns for 900 mcg Albuferon, the elimination of 1200 mcg will certainly reduce the drug’s market potential. Therefore we modified our sales estimate for Albuferon to reflect the change of the trials.
Data from two phase III trials for Benlysta is expected to be available in July and November, respectively
Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered by HGSI that is required for the development of B-lymphocyte cells into mature plasma B cells.
HGS is co-developing Benlysta with
GlaxoSmithKline (
GSK -
Analyst Report) as a potential treatment for
systemic lupus erythematosus (SLE) and certain other autoimmune diseases.
In February and May 2007, HGS initiated BLISS-76 and BLISS-52, two pivotal phase III trials of Benlysta. Both phase III trials are double-blind, placebo-controlled, multi-center phase III superiority trials to evaluate the efficacy and safety of Benlysta plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE.
The primary efficacy endpoint of both trials is the patient response rate at Week 52, as defined by a reduction from baseline in the SELENA SLEDAI score of at least 4 points, no worsening in Physician’s Global Assessment, and no worsening in BILAG. Important secondary endpoints will include the patient response rate at Week 76, the SF-36 Health Survey physical component summary score, fatigue measures, and the percentage of patients with reduction from baseline in average prednisone dose at Weeks 40-52.
