Novartis enters late-stage trials for new hepatitis C drug
pharmafile | December 21, 2006 | News story | Research and Development, Sales and Marketing |
Novartis, in collaboration with a US biotech company, has initiated phase III trials of a chronic hepatitis C drug that could significantly reduce the side-effects of current treatments.
The clinical programme includes two randomised trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with the current ribavirin treatment (Roche's Copegus), versus Roche's other hepatitis drug Pegasys, also in combination with ribavirin.
Albuferon has been produced by Maryland-based Human Genome Sciences, which has spent six years developing the drug to late-stage trial status.
HGS has received an upfront payment of $45 million from Novartis and stands to gain as much as $507 million in total from the drug, which is expected to be filed for global marketing in 2009.
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the company's own albumin fusion technology. The drug was developed from the genetic fusion of human albumin and interferon alpha.
Research has shown that genetic fusion of therapeutic proteins to human albumin prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
H Thomas Watkins, president and chief executive of HGS said: "We are pleased to advance Albuferon to phase III clinical trials. Hepatitis C is the most common chronic blood-borne infection in the developed world."
He added: "We believe Albuferon could become the interferon of choice in treatment regimens for this potentially devastating disease."
Novartis and HGS say Albuferon has a distinct advantage over current treatments, as patients only need half the number of injections. They say clinical results to date suggest its clinical safety is at least comparable to pegylated interferon and it has demonstrated a noticeable drop in the number of known side-effects experienced with current medications.
John McHutchison, professor of medicine and director of GI/hepatology at North Carolina's Duke University Medical Centre, said: "There continues to be a significant need for more effective and better tolerated treatments for chronic hepatitis C. We look forward to continuing the evaluation of Albuferon in larger populations in phase III trials."
Hepatitis C is a viral inflammation of the liver. It is estimated that as many as 170 million people are infected worldwide. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as suffering from the chronic form of the illness, which can cause serious liver disease leading to cirrhosis, primary liver cancer and death.
