Successful strategies for launching fixed dose combination products to market

The pharmaceutical industry is under constant pressure to produce new products and fixed dose combination therapies are one of the industry's strategies to offset lackluster pipelines and patent loss. But there is more to success than just developing a new FDC and launching it - successful research and development leaders recognize that understanding the market and audience will smooth the FDC launch process, according to a Best Practices, LLC FDC study.

A third of the FDC leaders who participated in the study said the most important lesson learned from their work with FDC products is the need to focus on the differentiated benefit and value that the product can bring to patients, physicians and payers. "You have to understand the customer groups you're talking to. Primary care physicians want a friendly missile. They want to give you the pill and get you out of their hair in 10 minutes or less. Scientists want to tinker with everything. They want a pinch of this and a dab of that," one R&D veteran noted in the report.

In short, FDC success is determined in the market, not the lab, according to "Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market." 

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
• Specific reimbursement challenges
• Strategies, tactics, practices to help accelerate or impede launch progress
• Lessons learned from executives
• Metrics for effectively communicating business value