Procter & Gamble and Hoechst Marion Roussel Submit Regulatory Applications for Risedronate

Strategic Insights -

Procter & Gamble Pharmaceuticals and Hoechst Marion Roussel have simultaneously submitted applications in the United States and Europe for the regulatory approval of risedronate (Actonel) for the prevention and treatment of osteoporosis. The companies are seeking approval for Actonel in both the US and Europe for post-menopausal osteoporosis and corticosteroid-induced osteoporosis, as well as Paget's disease in Europe. The applications are based on the results of 11 clinical studies involving over 16,000 patients from 18 countries.

Key Takeaways:

  • Procter & Gamble Pharmaceuticals and Hoechst Marion Roussel have submitted regulatory applications in the US and Europe for the approval of risedronate (Actonel) for the treatment of osteoporosis.
  • The applications cover the use of Actonel for post-menopausal osteoporosis, corticosteroid-induced osteoporosis, and Paget's disease in Europe.
  • The clinical trials for Actonel included 11 separate studies involving over 16,000 patients from 18 countries.
  • Actonel increased bone mass and reduced the risk of bone fractures in clinical studies.
  • Procter & Gamble and Hoechst Marion Roussel plan to co-promote Actonel in North America and select European markets, while Hoechst Marion Roussel will market the product independently in other global markets.
  • The companies are committed to getting Actonel to patients as quickly as possible, utilizing the full resources of their strategic alliance.

Statistics:

  • The clinical trials for Actonel involved over 16,000 patients from 18 countries.
  • Actonel increased bone mass in clinical studies.
  • Actonel reduced the risk of bone fractures in clinical studies.
  • The estimated direct and indirect healthcare costs of osteoporosis are as high as $20 billion.
  • Procter & Gamble Pharmaceuticals is a $38 billion global leader in the development, manufacturing, and marketing of consumer goods.

Sources:

  • Procter & Gamble Pharmaceuticals (NYSE: PG)
  • Hoechst Marion Roussel
  • U.S. Food & Drug Administration (approved Actonel for the treatment of Paget's disease in the US in March 1998)
  • Securities and Exchange Commission (Hoechst AG Registration Statement on Form 20-F)