Genentech Responds to FDA Probe and Negative Wall Street Journal Report

Strategic Insights -

Genentech, Inc. has denied any wrongdoing in regards to the Food and Drug Administration (FDA) probe of its marketing practices, calling reports "old news." The company has been cooperating with the FDA for months and has discussed the investigation publicly. Genentech's president and CEO, G. Kirk Raab, stated that the company has no reason to believe the House Subcommittee on Oversight and Investigations is still investigating the GUSTO clinical trial. The FDA had previously recommended the accelerated dose of Activase(r) (Alteplase, recombinant) t-PA for marketing, citing the significant survival benefits demonstrated in the GUSTO heart attack study.

Key Takeaways:

  • Genentech denied any wrongdoing in regards to the FDA probe of its marketing practices, calling reports "old news."
  • The company has been cooperating with the FDA for months and has discussed the investigation publicly.
  • Genentech's president and CEO, G. Kirk Raab, stated that the company has no reason to believe the House Subcommittee on Oversight and Investigations is still investigating the GUSTO clinical trial.
  • The FDA had previously recommended the accelerated dose of Activase(r) (Alteplase, recombinant) t-PA for marketing, citing the significant survival benefits demonstrated in the GUSTO heart attack study.
  • Several expert securities analysts have responded to the Wall Street Journal article, with Smith Barney stating that the article is "sensationalist" and Cowen & Co. predicting that the article will have no major impact on sales.
  • Genentech has headquarters in South San Francisco, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
  • The company is a leading international biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs.
  • In June 1994, the FDA Cardio-Renal Advisory Committee unanimously recommended the accelerated dose of Activase(r) (Alteplase, recombinant) t-PA for marketing.

Statistics:

  • 41,000 patients participated in the GUSTO clinical trial comparing thrombolytic therapies in the treatment of heart attack.
  • The FDA had previously recommended the accelerated dose of Activase(r) (Alteplase, recombinant) t-PA for marketing, citing the significant survival benefits demonstrated in the GUSTO heart attack study.
  • Genentech is a leading international biotechnology company with headquarters in South San Francisco, California.

Sources:

  • Business Wire, "Genentech Responds to FDA Probe and Negative Wall Street Journal Report" (November 10, 1994)
  • Genentech, Inc., "Genentech, Inc. Profile" (no date)
  • Wall Street Journal, "Genentech Faces FDA Probe" (no date)
  • Smith Barney, "Genentech: No Reason to Sell" (no date)
  • Cowen & Co., "Genentech: Expect No Major Impact on Sales" (no date)