In September 2008 the FDA launched a new federal programme designed to increase the amount of work being undertaken in certain neglected tropical infectious diseases. (implemented by the FDA amendments act of 2007). This programme will award a sponsor of a drug for a tropical disease a voucher entitling the company an expedited review for any other drug application. The expedited review can reduce the time for a review from 18 to 6 months saving upwards of a year, which can add extra time on market giving some additional $300million plus in additional sales.
Whilst most small companies developing drugs in Tropical Diseases would be unlikely be in a position to take full advantage of these vouchers and access there full potential value, the regulations allows the original sponsor company to sell this voucher to another company. This is the real trick to these regulations. This voucher represents a significant asset, to be exploited and can be a critical element of your licensing negotiations with larger companies once you have developed your product, and these neglected tropical diseases are likely to be considered orphan in the USA so reduced development programmes and speedier registration are likley ot be obtainable.
On its own its impact is interesting but when combined with other regulatory pathways it can be a powerful way of building value quickly into your product, fast tracking you to approval, generating an valuable asset and getting your technology ready for a mainstream registration via a licensing deal with a larger pharmaceutical company.
We have looked at these regulatory strategies as part of our work as drug development consultants. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Your site displays incorrectly in Firefox, but content excellent! Thank you for your wise words:)
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