Genentech and Alkermes Announce Plans to Submit New Drug Application for Nutropin Depot

Strategic Insights -

Genentech, a leading biotechnology company, and Alkermes, a developer of sophisticated drug delivery technologies, have announced plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nutropin Depot, a sustained release formulation of recombinant human growth hormone (rhGH). The decision was based on the successful completion of a multi-center Phase III clinical trial, which evaluated the safety, tolerability, and efficacy of Nutropin Depot in children with growth hormone deficiency.

Key Takeaways:

  • The Phase III clinical trial was conducted with 74 patients at 27 centers in the United States from December 1997 through March 1998.
  • Two different dosing regimens were evaluated: 36 patients received subcutaneous injections of Nutropin Depot once a month, while 38 patients received subcutaneous injections twice a month.
  • The primary efficacy endpoint of the trial was linear growth rate at six months, annualized.
  • Nutropin Depot is designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres that slowly release rhGH.
  • Alkermes is focused on completing the validation and start-up of its manufacturing facility in Cambridge, Massachusetts.
  • Genentech aims to provide patients and their families with alternatives for growth hormone therapy.
  • Final results from the study are expected to be presented at a scientific meeting in 1999.

Statistics:

  • 74 patients were enrolled in the Phase III clinical trial.
  • 36 patients received subcutaneous injections of Nutropin Depot once a month, while 38 patients received subcutaneous injections twice a month.
  • The trial was conducted at 27 centers in the United States.
  • The Phase III clinical trial lasted for 6 months.

Sources:

  • Genentech, Inc., and Alkermes, Inc. (1998, October 22). Genentech and Alkermes Announce Plans to Submit New Drug Application for Nutropin Depot. Business Wire.
  • Alkermes, Inc. Annual Report (1998).