Be cautious when considering a Fixed Dose Combination!

(by Neal Hansen, expert-trainer of the
Late Stage Pharma Lifecycle Management course)

Developing a Fixed Dose Combination (FDC) is one of the developmental lifecycle management (LCM) strategies pharma marketers can opt for.

However, the resistance to premium priced FDCs is likely to be high in today’s tougher market environment, particularly when launching an FDC towards the end of a product’s lifecycle.

Therefore, companies must carefully examine the critical success factors for such strategy to be effective:

The FDC must target a tangible unmet need and improve the competitive profile of the parent brand. Ideally this means that the FDC:
		°	Has proven to be superior to each molecule separately
		°	Has proven to be superior to other FDCs on the market
		°	Has proven to be superior to the free association of both molecules
			If the above is not the case, the FDC drug must be attractive to critical stakeholders for other reasons (price, compliance, convenience,...)
Where possible, the FDC should expand the scope of the molecule into new indications or new patient populations
The FDC must gain patent protection and/or market exclusivity and where possible extend the protected life of the parent brand franchise
In short, before developing your FDC drug, you need a positive answer to four questions:
	Does the FDC meet an unmet need in the market? Does the FDC fit with day-to-day treatment practice? Will the FDC provide me with a competitive advantage? Will I be able to establish a strong protection for my FDC?
If the answers to any of the above questions is no, you’d better think twice!

Learn much more from Neal Hansen at the Late Stage Pharma Lifecycle Management course

“ This course is an excellent opportunity to learn about the rationale of LCM, its aspects and how to apply it. Great opportunity as well to discuss specific problems with the excellent trainer Neal Hansen and the course participants.”

Killian Duffner, Senior Vice President, Grünenthal - Germany

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