[Ip-health] How Much? Gilead Pays $125M For an FDA Priority Review Voucher

Claire Cassedy claire.cassedy at keionline.org
Thu Nov 20 08:36:27 PST 2014


http://blogs.wsj.com/pharmalot/2014/11/19/how-much-gilead-pays-125m-for-an-fda-priority-review-voucher/

How Much? Gilead Pays $125M For an FDA Priority Review Voucher

3:41 pm ET Nov 19, 2014

By  ED SILVERMAN

For the first time since the FDA began a voucher program several years ago
to encourage development of drugs to treat neglected tropical diseases, a
drug maker has sold a voucher to another company. And the deal may help the
pharmaceutical industry ballpark the value of these vouchers.

In a brief statement, Knight Therapeutics says Gilead Sciences agreed to
pay $125 million for a voucher that the small Canadian drug maker obtained
from the FDA last March. The agency awarded the voucher at the same time it
approved Impavido, a medication that Knight developed to treat
leishmaniasis, a parasitic disease spread by sand flies.

The program has generated interest, because a drug maker that develops a
treatment for a qualifying tropical disease receives a voucher for an FDA
priority review for another medicine, which means the agency would be
obligated to review the medicine in six months, instead of the standard 10
months.

The deal is akin to a grand bargain in that public health is promoted by
development of a medicine that may not otherwise become available and a
drug maker can profit, because a speedier review means an approved medicine
could be sold sooner and generate revenue. In this instance, Gilead is now
free to use the voucher for faster FDA approval of any type of drug.

But determining the value of such a voucher for tropical disease drugs has
been difficult. In part, this may reflect a regulatory restriction. The FDA
had stipulated that a drug maker must notify the agency of its intent to
submit a marketing application with a voucher at least 365 days before an
application is submitted. Although Congress wants to cut that to 90 days as
part of a bill to add Ebola to the list of tropical diseases.

Moreover, since the program began in 2007, only a few such vouchers have
been awarded for tropical disease drugs and none had previously been sold.
Now, though, the sale to Gilead suggests that the pharmaceutical industry
will have a benchmark.

“I can see that at the rate of $125 million, there will be a substantial
incremental incentive to get drugs for tropical diseases registered in the
U.S.,” Aidan Hollis, a professor of economics at the University of Calgary,
who has followed the priority voucher program.

There was one other sale of a priority review voucher, which sold for $67.6
million, about half of what Gilead is paying. However, that deal involved
another FDA program for developing drugs to treat rare pediatric diseases,
which can be redeemed in just 90 days.

Last July, BioMarin Pharmaceuticals sold a voucher to Regeneron
Pharmaceuticals and Sanofi, which plan to use it to obtain faster FDA
approval for a new type of cholesterol drug, a PCSK-9 inhibitor.

As for Gilead, which sells various medications to combat HIV and hepatitis
C, including the Sovaldi and newly approved Harvoni treatments, the drug
maker is not saying how the voucher may be used. We should note that the
voucher cannot be redeemed for 365 days.

A Gilead spokesman writes us that there are a “number of potential clinical
candidate in our pipeline where this could be beneficial. We will make the
decision to apply the priority review voucher with ongoing internal
pipeline reviews.”

[UPDATE: This post was updated to reflect that Congress wants to cut that
to 90 days as part of a bill to add Ebola to the list of tropical diseases.]



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