Hepatitis C drug Albinterferon alfa-2b nearing FDA approval in US: Human Genome Sciences

Human Genome Sciences, Inc is seeking approval for albinterferon alfa-2b (Zalbin)  for the treatment of chronic hepatitis C.

A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration for albinterferon alfa-2b (Zalbin), Human Genome Sciences said in a press release.

Human Genome Sciences’ BLA submission is based on the results of two pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) dosed once each week.

The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naïve patients with chronic hepatitis C.

In both studies, albinterferon alfa-2b, with half the injections, achieved sustained virologic response comparable to that achieved by peginterferon alfa-2a. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2255 patients.

“Assuming licensure by the FDA and other regulatory agencies, HGS believes Zalbin could become an important treatment for chronic hepatitis C. Novartis targets submission of marketing authorization applications under the brand name Joulferon in the rest of the world later this quarter, beginning with Europe,”“stated  H. Thomas Watkins, President and Chief Executive Officer, HGS.

Zalbin (also known as Joulferon) is a genetic fusion of human albumin and interferon alfa created using 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.

HGS and Novartis will co-commercialize albinterferon alfa-2b in the United States as Zalbin, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally, under an exclusive worldwide co-development and commercialization agreement entered into in 2006.

Novartis will be responsible for commercialization of albinterferon alfa-2b as Joulferon in the rest of the world, and will pay HGS a royalty on those sales. These brand names will be subject to confirmation by health authorities at the time of product approval.

HGS has primary responsibility for the bulk manufacture of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $207.5 million received to date.

The remaining payments to HGS under the agreement relate to the achievement of certain regulatory approval and commercial milestones.

Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. Nearly 170 million people worldwide are infected with hepatitis C virus, it is estimated. 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. Patients infected with the genotype 1 hepatitis C virus account for approximately 75% of the chronic hepatitis C patients in the U.S.

Human Genome Sciences’ clinical development pipeline includes novel drugs to treat lupus, hepatitis C, inhalation anthrax and cancer. The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, Benlysta (belimumab) for lupus and Zalbin (albinterferon alfa-2b) for hepatitis C.

Phase 3 development has been completed successfully for both BENLYSTA and Zalbin. The submission of marketing applications for Benlysta is planned in the U.S., Europe and other regions in the first half of 2010. A BLA has been submitted for Zalbin to the FDA in the United States, and Novartis targets submission of marketing authorization applications under the brand name Joulferon in the rest of the world, beginning with Europe in fourth quarter 2009.

In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the Stockpile over a three-year period beginning near the end of 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax.

Human Genome Sciences also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of inhibitor-of-apoptosis proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.