Event Analysis and Response Service: Cox-2s

Summary

On 30th September 2004, Merck withdrew its blockbuster drug Vioxx from the global market after trial data reinforced the suspicion that it increased the risk of cardiovascular events. Vioxx was a widely used Cox-2 selective non-steroidal anti-inflammatory drug. Its withdrawal has sparked much speculation, regulatory review and a shakedown within the pharmaceutical industry.

Highlights

• Key clinical trials, including the evidence leading up to Merck's decision to withdraw Vioxx and results from various long-term clinical trials involving other members of the Cox-2 class, are examined.
• Detailed analysis of the FDA and EMEA evaluations of the Cox-2s, including a review of the three day FDA advisory committee meeting held in February and analysis of the main conclusion with respect to the impact on current and future treatments, are provided.
• Opportunities and threats within the market, and strengths and weaknesses of the key brands, are identified and used to provide up-to-date global forecasts. The key brands are forecast to 2010 and are based on company reported sales data, with clear positive and negative impacting assumptions.

Scope

• Seven analysis statements, originally published in response to major events in the Cox-2 story between November 2004 and May 2005
• Each statement is based on the information available at that time, and captures the rapidly changing market dynamics and current opinion
• Forecasts are based on the continually updated PharmaVitae Company Comparator forecast tools and company reported global sales
• The key brands analyzed include Vioxx, Bextra, Celebrex, Arcoxia, Mobic and Prexige

Reasons to Purchase

• Understand the progression and commercial impact of the safety concerns highlighted by the investigation into the Cox-2 class
• Cuts through the media 'shock news' and provides an indispensable fact based reference document with clear and non-biased analysis
• Assess future strategic decisions using this in-depth commercial case study as a benchmark

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