Restasis, Allergan

Restasis (cyclosporine ophthalmic emulsion)
Chronic dry eye
Allergan
Global Sales 2012:
$792 million
U.S. Sales 2012: Not reported, but ex-U.S. sales are "modest," company says
Expiration Date: May 2014

For an idea of how important Restasis is to Allergan ($AGN), just consider what happened to the company's stock in June 2013. That's when the FDA decided potential copycats wouldn't need to go through clinical trials, as Allergan had expected. The company's shares plummeted by 12%. Analysts downgraded the stock and cut their price targets. When CEO David Pyott announced second-quarter earnings, the questions immediately zeroed in on Restasis. He promised to fight the FDA's decision, saying the company would also "further contemplate taking every appropriate legal and regulatory action" to protect the drug.

No wonder: Allergan had just kicked off a new consumer advertising campaign, and Q2 Restasis sales were up more than 10%. Its full-year forecast for the drug: up to $900 million, and most of the dry-eye treatment's sales are booked in the U.S.

Since then, Allergan has written the FDA to demand a higher standard for Restasis copies. The argument: Lab tests can't properly assess bioequivalence in an eye drug because of the "unique and challenging" ocular environment. So far, the FDA hasn't responded. In the past, when drugmakers have petitioned for a change in generics requirements, they've followed up in court if the agency hasn't come through. Allergan probably would do the same.

For more:
Special Report: Top 10 DTC Pharma Advertisers - Allergan
Allergan pushes FDA to defend Restasis from early generics
Allergan skids on probability of early Restasis generics
If Allergan went on the block, would Big Pharma bite?

-- Tracy Staton (email | Twitter)

Restasis, Allergan
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