[Ip-health] FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

Tahir Amin tahir at i-mak.org
Wed Oct 15 10:06:39 PDT 2014


FDA Changes Policy Hours Before Approvals, Giving Companies Gift
Potentially Worth Billions
 Posted 13 October 2014
By Alexander Gaffney, RAC

On Friday, two companies were the lucky recipients of gifts never before
given by the US Food and Drug Administration (FDA)—gifts potentially worth
millions, if not billions of dollars in value.

In the US, pharmaceutical manufacturers who obtain approval to market a
"new" drug from FDA are eligible for varying degrees of market- (rather
than patent-) based exclusivity.

For New Chemical Entities (NCEs), that means five years of protection
during which time FDA will not approve any generic equivalents. For "new"
drugs that represent a new use for an old drug, or a new dose of an old
drug, FDA is able to grant just three years of patent protection.

Historically, that meant that a fixed-dose combination (FDC) product
consisting of at least one already-approved entity was ineligible for five
years of exclusivity—just three.
New Guidance

But on the morning of 10 October 2014, FDA released a new, final policy
which markedly changed its interpretation of the drug marketing exclusivity
provisions of the *Federal Food, Drug and Cosmetic Act (FD&C Act)* in
response to multiple petitions
<http://www.raps.org/regulatoryDetail.aspx?id=9210> from the pharmaceutical

"Accordingly, a 5-year NCE exclusivity determination will be made for each
drug substance in a drug product, not for the drug product as a whole," FDA
wrote in the guidance, *New Chemical Entity Exclusivity Determinations for
Certain Fixed-Dose Combination Drug Products*

"As a result, an application for a fixed-combination submitted under
section 505(b) of the *FD&C Act* will be eligible for 5-year NCE
exclusivity if it contains a drug substance, no active moiety of which has
been approved in any other application under section 505(b).30," FDA
explained. "For example, a fixed-combination drug product that contains a
drug substance with a single, new active moiety would be eligible for
5-year NCE exclusivity, even if the fixed-combination also contains a drug
substance with a previously approved active moiety."

However, the policy came with a significant setback for industry: The new
policy would only be effective as of 10 October 2014, and not retroactively.
New Approvals

But while that policy was a potential setback for the sponsors of 19
already-approved FDCs (some of which might not be eligible for the
protection), it's now a boon for two FDCs approved on 10 October 2014.

Just hours after FDA released its final FDC exclusivity policy, it
announced the approval of Gilead's Harvoni (ledipasvir and sofosbuvir), a
FDC used to treat chronic hepatitis C virus genotype 1 infections, and
Eisai's Akynzeo (netupitant and palonosetron), an FDC used to treat nausea
and vomiting in patients undergoing cancer chemotherapy.

Had the drugs been approved just one day earlier, neither would have been
eligible for NCE exclusivity. Gilead's Harvoni includes sofosbuvir, a drug
approved in 2014 and marketed as Sovaldi. Eisai's Akynzeo includes oral
palonosetron, approved in 2008 under the brand name Aloxi.

But in addition to the existing drugs, both products contain new chemical
entities that boost the effectiveness of the products. Harvoni's
ledipasvir, for example, allows the drug to be used without interferon or
ribavirin. Akynzeo's netupitant apparently boosts the effectiveness of the
drug, protecting a patient from nausea and vomiting "during both the acute
phase and delayed phase after the start of chemotherapy."

For both companies, the additional two years of market exclusivity could
potentially be valuable. Harvoni is expected to become a blockbuster
meaning Gilead will have at least two extra years to reap billions in
revenue before it has to begin defending its patents on the drug in
earnest. Gilead said it plans to sell the product for $94,500 for a 12-week
course of treatment.

And while projected sale data for Akynzeo was not available, it's hard to
envision a scenario in which an extra two years of exclusivity could
possibly hurt a company's bottom line. Sales of the drug's predecessor,
Alixo, reached $537 million in 2011 according to data from *Evaluate*

Both Harvoni's
and Akynzeo's
market exclusivity periods end on 10 October 2019,
- See more at:

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472

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