Novartis Acquires Rights to Albuferon in Deal with Human Genome Sciences

Novartis has taken a significant step in expanding its hepatitis C portfolio with an exclusive worldwide agreement to acquire the rights to Albuferon, an investigational drug developed by Human Genome Sciences (HGSI). Albuferon is poised to enter phase III clinical trials for the treatment of chronic hepatitis C infections and is designed to offer a valuable treatment option for patients with a long half-life and consistent plasma levels. The agreement comes as a major breakthrough in addressing the unmet medical need for more effective and tolerable interferons.

Key Takeaways:

  • Novartis has acquired exclusive worldwide rights to Albuferon, a novel recombinant protein that combines interferon alfa with human serum albumin, designed to offer a long half-life and improved efficacy and safety/tolerability profile compared to pegylated interferons.
  • The agreement involves an upfront payment of $45 million to Human Genome Sciences, with milestones payable at specific stages of development and sales milestones payable following launch.
  • Albuferon is expected to enter phase III clinical trials by the end of 2006, addressing the need for a more effective and tolerable treatment option for chronic hepatitis C patients.
  • Novartis will copromote Albuferon with Human Genome Sciences in the U.S. and have exclusive rights to market and promote it in the rest of the world.
  • The addition of Albuferon is part of Novartis's strategy to build a leading hepatitis C portfolio with complementary mechanisms of action, including immunomodulators and direct antivirals.
  • Albuferon's ability to interfere with the viral life cycle at different stages may lead to better outcomes when combined with other antiviral compounds.
  • The Novartis portfolio includes other compounds such as valopicitabine (NM283), NIM811 and ANA795, designed to tackle hepatitis C in different ways.

Statistics:

  • $45 million: Upfront payment to Human Genome Sciences as part of the agreement.
  • End of 2006: Expected start date for phase III clinical trials for Albuferon.
  • 50%: Cure rate associated with pegylated interferons for patients with genotype 1 hepatitis C.
  • 60%: Incidence of side effects associated with pegylated interferons.

Sources:

  • Novartis
  • Human Genome Sciences
  • Health & Medicine Week
  • NewsRx.com