Tag Archives: priority review vouchers

FDA, the US Drug Regulator, Reminder of Tropical Disease Priority Review Vouchers

Posted on July 15, 2010 by admin| Leave a comment

FDA, the US Drug Regulator, Reminder of Tropical DIsease Priority Review Vouchers

This guidance provides information on the implementation of section 1102 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which adds new section 524 to the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360n). Section 524 authorizes FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified by the Act. A priority review voucher may be used by the sponsor who obtains it or another sponsor to obtain a priority review for a different application. A priority review voucher may be transferred from the sponsor who obtains it to another sponsor.

These vouchers are valued at between US$50 and US$300 million, and there is grant money available to fund development it is a great way of generating large anounts of value whilst saving lives.

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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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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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Merck & Co Great Strategy for Tropical Disease Voucher Production

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Priority Review Vouchers – and there off

Posted on April 9, 2009 by admin| Leave a comment

Some time ago we published an article about Priority Review Vouchers and how they could potentially be worth US$300million, although I have just read an estimate of US$50 to US$500 million. Well it has started now watch this space,Yesterday the FDA announced the approval of Norvartis’ combination drug product Coartem (artemether, lumefanterine) for the treatment of acute uncomplicated malaria infections in adults and children weighing at least five kilograms, and the FDA has awarded them a priority review voucher. It remains to be seen if they sell it on, for the estimated millions, or use it to speed up their own products.

For those of you who don’t know about these vouchers, how they work is if you develop a new drug against certain tropical diseases (there is a list available) the FDA gives you a voucher that can be used to grant an accelerated approval process to any product, a voucher that can be sold on. Because these vouchers if applied to a potential block buster can bring forward your access to market by at least 4 months, combined with shorter remaining patent lives on new drugs leaving development, they are expected to be worth many millions of dollars, as mentioned above values of US$500 million are being banded about.

This is obviously quite disruptive to business strategy, it could be possible to take a drug all the way to registration in a rare tropical disease with grants and charity contributions, reducing the amount needed to be raised and boosting your remaining equity well beyond what would normally be expected, then get your voucher, sell it for the many millions to fund your programmes in western disease. Its a strategy that will add significant time to your development programme but you will be sitting on the equity but its a strategy to be considered and there are many others.

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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