HGSI: NDA for Albuferon Expected to be Filed This Fall
Waiting for 2 Phase III Results for Benlysta
NDA filing for Albuferon is expected in the fall for Hepatitis C
Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
Human Genome Sciences Inc. (
HGSI -
Analyst Report) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.
HGSI has an exclusive worldwide agreement with
Novartis (
NVS -
Snapshot Report) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for
chronic hepatitis C (HCV). Under this agreement, Novartis will co-develop and co-commercialize Albuferon and share equally in development costs, sales and marketing expenses and profits of any product that is commercialized in the U.S. Novartis will be responsible for commercialization outside the U.S. and will pay HGS a royalty on these sales.
HGSI has finished two pivotal phase III trials: ACHIEVE 1, the first pivotal phase III clinical trial of Albuferon in combination with ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) and ACHIEVE 2/3, a second phase III clinical trial of Albuferon in combination with ribavirin in treatment-naïve patients with chronic hepatitis C genotypes 2 and 3. Both trials are randomized, open-label, active-controlled, multi-center, non-inferiority trials that will evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS in combination with ribavirin.
Both trials are designed to evaluate two doses of Albuferon administered every two weeks, versus an active-control arm in which patients will receive PEGASYS on a standard once-weekly regimen. ACHIEVE 1 is being conducted in patients with genotype 1 HCV, and the second trial, ACHIEVE 2/3, will be conducted in patients with genotype 2/3 HCV. The primary efficacy endpoint of both trials is sustained virologic response, defined as undetectable HCV RNA.
