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Report Highlights Successful Strategies for Bringing FDC Products to Market

CHAPEL HILL, N.C., Jan. 5, 2011 /PRNewswire/ -- The pharmaceutical industry's steep patent cliff and relatively lackluster pipeline is pushing strategy and development executives to uncover opportunities for sustainable growth in 2011. One opportunity lies in combination therapies with branded products to extend patent life. For pharma companies, fixed dose combination (FDC) products can extend a therapeutic advantage and become part of lifecycle management. For the patient, FDC products can address unmet medical needs and reduce pill burdens.

While FDC products can have clinical and commercial advantages, they also can be challenging to bring to market. A new Best Practices, LLC report found it takes between five and eight years and an average of $80 million to bring a FDC product to market. One of the keys to successfully commercializing a FDC therapy is to create a differentiated product with a therapeutic benefit, according to the research project.

Indeed, critical product-shaping strategies such as positioning and value were tactics that veteran FDC leaders identified as most valuable for a successful launch of a FDC product, according to "Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market." As one R&D veteran noted in the report, "Bring some value to the payers. If a payer looks at it and there's not really any kind of clinical differentiation, whether it's better efficacy, speed of onset, better response, or better remission, the payers tell us very, very clearly that they're not interested."

Some of the issues addressed in this research include:

  • Chief reason for pursuing FDC development
  • Measures used to evaluate success
  • Years from decision to develop through launch
  • Cost of FDC product development Approximate
  • Difficulty areas for bringing FDC product to market
  • Reasons for partnering with another company to develop FDC product
  • Time lapsed from initial contact to signed contractual agreement with partner
  • U.S. filing routes used
  • EU filing routes used
  • Months from filing to approval
  • Pre-launch marketing challenges
  • Strategies, tactics, practices to help accelerate or impede launch progress
  • Lessons learned from executives
  • Metrics for effectively communicating business value

The full 55-page report contains more than 150 benchmark metrics, providing executives with the tools, tactics and techniques to help organizations successfully develop and commercialize fixed dose combination products. Review a complimentary summary of the study at The summary includes selected best practices drawn from extensive primary research with 51 representatives from 34 leading companies, including eight of the Top 20 pharma companies. 


Best Practices, LLC serves 48 of the world's 50 top pharmaceutical companies.  For 17 years, we have conducted work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.  For more information about the company, go to

SOURCE Best Practices, LLC
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