Human Genome Sciences Inc. Faces Setback in Pipeline Development

Strategic Insights -

Human Genome Sciences Inc. (HGSI) recently encountered a setback in the development of its hepatitis C candidate Joulferon (albinterferon alfa-2b) after its partner Novartis AG (NVS) withdrew the Marketing Authorization Application (MAA) from the European Medicines Agency (EMEA). This move was due to indications that the European regulatory authorities would request additional data, which the companies may not be able to furnish within the specified timeframe. Meanwhile, the company is optimistic about its lupus candidate Benlysta, co-developed with GlaxoSmithKline plc (GSK), which has blockbuster potential.

Key Takeaways:

  • Human Genome Sciences Inc. (HGSI) suffered a setback in the development of its hepatitis C candidate Joulferon (albinterferon alfa-2b) after Novartis AG (NVS) withdrew the Marketing Authorization Application (MAA) from the European Medicines Agency (EMEA).
  • The withdrawal of the MAA was based on indications that the European regulatory authorities would request additional data, which the companies may not be able to furnish within the specified timeframe.
  • The company's lupus candidate Benlysta, co-developed with GlaxoSmithKline plc (GSK), has blockbuster potential and is expected to be approved in the U.S. in the fourth quarter of 2010.
  • Joulferon will face competition from Merck's (MRK) PEG-Intron and Roche's (RHHBY) Pegasys in the interferon alpha market.
  • Human Genome intends to seek approval for Benlysta during the second quarter of 2010 in the United States and Europe.

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Sources:

  • Zacks.com announce
  • Zacks Equity Research
  • Zacks Investment Research, Inc.
  • European Medicines Agency (EMEA)
  • U.S. Food and Drug Administration (FDA)
  • Merck & Co. (MRK)
  • Novartis AG (NVS)
  • Human Genome Sciences Inc. (HGSI)
  • GlaxoSmithKline plc (GSK)
  • Roche Holding Ltd. (RHHBY)