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Pharmaceutical industry

Human Genome Sciences and Lonza Group Announce Commercial Supply Agreement for BENLYSTA

Strategic Insights

— 2 min read

Human Genome Sciences, Inc., a biopharmaceutical company, has announced an agreement with Lonza Group, a Swiss chemicals and biotechnology company, for the future commercial supply of BENLYSTA (belimumab). This agreement is in place for the commercial supply of BENLYSTA, a potential new treatment for systemic lupus erythematosus (SLE), which is currently under regulatory review in the United States and Europe.

The agreement follows successful preclinical and clinical studies demonstrating that belimumab reduced autoantibody levels in SLE patients. Two pivotal Phase 3 trials, BLISS-52 and BLISS-76, showed that belimumab reduced SLE disease activity. Randy Maddux, Vice President of Manufacturing Operations at Human Genome Sciences, stated that the company's manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, but additional capacity will be required in the long term. The company has selected Lonza as a commercial manufacturing partner due to its leadership in biologics manufacturing and global production network.

GlaxoSmithKline, a co-developer and commercialization partner for BENLYSTA, submitted a Marketing Authorization Application to the European Medicines Agency in June 2010, seeking approval to market belimumab in Europe. Human Genome Sciences submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States. No new drug for lupus has been approved by regulatory authorities in more than 50 years. This agreement solidifies a long-term collaborative relationship between Human Genome Sciences and Lonza for the commercial supply of BENLYSTA.

Key Takeaways:

  • Human Genome Sciences has announced an agreement with Lonza Group for the commercial supply of BENLYSTA, a potential new treatment for systemic lupus erythematosus, currently under regulatory review in the United States and Europe.
  • Preclinical and clinical studies demonstrated that belimumab reduced autoantibody levels in SLE patients and reduced SLE disease activity in two pivotal Phase 3 trials, BLISS-52 and BLISS-76.
  • The agreement follows a careful review of proposals from commercial manufacturing organizations, with Lonza selected due to its leadership in biologics manufacturing and global production network.
  • The company's manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, but additional capacity will be required in the long term.
  • This agreement solidifies a long-term collaborative relationship between Human Genome Sciences and Lonza for the commercial supply of BENLYSTA.
  • GlaxoSmithKline, a co-developer and commercialization partner, submitted a Marketing Authorization Application to the European Medicines Agency in June 2010, seeking approval to market belimumab in Europe.
  • Human Genome Sciences submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States.
  • No new drug for lupus has been approved by regulatory authorities in more than 50 years.

Statistics:

  • 50 years: The time period since a new drug for lupus has been approved by regulatory authorities.
  • 2: The number of pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrating that belimumab reduced SLE disease activity.
  • 2010: The year GlaxoSmithKline submitted a Marketing Authorization Application to the European Medicines Agency seeking approval to market belimumab in Europe.
  • 2010: The year Human Genome Sciences submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States.

Sources:

  • "Human Genome Sciences and Lonza Group Announce Agreement for Commercial Supply of BENLYSTA" (Contify.com)
  • "Human Genome Sciences and GlaxoSmithKline Provide Update on Development and Commercialization of BENLYSTA" (GSK.com)
  • "Human Genome Sciences and GlaxoSmithKline Announce Collaboration for Commercialization of BENLYSTA" (HGS.com)

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