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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.
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While FDC products can have clinical and commercial advantages, they also can be challenging to bring to market. A 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 study.
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- Approximate cost of FDC product development - 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
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 http://www3.best-in-class.com/rr1285.htm. 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.
ABOUT BEST PRACTICES, LLC: Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations.
SOURCE Best Practices, LLC
