Tag Archives: Neglected disease

Merck & Co Great Strategy for Tropical Disease Voucher Production

Posted on November 1, 2009 by admin| Leave a comment

Merck & Co Great Strategy for Tropical Disease Voucher Production

I have read a great story in First Word (Click here)

Merck & Co. and the UK charity Wellcome Trust announced Thursday the creation of a joint venture that will focus on developing affordable vaccines against diseases that commonly affect low-income countries. I don’t doubt that Merck are keen to be do good but there is a great upside that I am sure will not be lost on Merck – Priority Review Vouchers. Its a topic that we have covered a few times on this site, but if you get a technology approved for a neglected tropical disease the FDA will award you a Priority Review Voucher that you can use or sell as you see fit. The estimated value of these vouchers is put at between US$50 million and US$300 million. It looks like Merck have developed a system of producing these vouchers as quickly as possible and getting charities involved to share the cost too, somebody at Merck needs a huge bonus for this one, and think of the huge global health benefits its going to deliver.

for more article on this topic try – Click Here1 and Click Here2

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Neglected Diseases – FDA Review Vouchers – a new source of revenue

Posted on January 26, 2009 by admin| 3 Comments

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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