Generic drugmaker Watson Pharmaceutical ($WPI) is going to court trying to force the FDA to allow it to launch the generic version of a drug that has itself spawned thousands of liability lawsuits for developer Takeda Pharmaceutical.
Watson was prepared to launch a generic version of Type II diabetes drug Actos Friday of this week after negotiating six-month exclusivity with Takeda Pharmaceutical. But the FDA threw a wrench into the works when it challenged its "shared exclusivity," an action that it says could cost it a 6-month delay and, of course, six months worth of revenue. Citing IMS Health data, Actos generated about $2.7 billion in sales in the 12 months ending May 31.
Without disclosing the issue, the company claims it tried negotiating with the FDA and today said it filed suit when those talks failed. "We believe that we have sound arguments that refute FDA's position and will seek the court's intervention to enable approval," CEO Paul Bisaro says in a statement.
In a heads up to investors, the company says if it can't force the issue with the FDA, it believes it can still hit its recently released 2012 earnings projections. With its recently announced deal to buy Swiss-based rival Actavis for $5.6 billion up front, plus a potential $306.9 million (€250 million) worth of stock in milestone payments, the company is anxious to generate all of the revenue that it can.
But with Actos, it gets a drug with some baggage. While Takeda has defended its effectiveness and safety, the FDA last year required the Japanese company to add a warning of possible bladder cancer risks. France made the drugmaker remove Actos from the market there. There are estimates that Takeda could face up to 10,000 lawsuits from patients who say they were not properly warned of the added risk.
- here's the release
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