[See #msg-29708517 for the convoluted history of this case, which originally focused on ABT’s use of multiple generic-preventing 30-month stays under Hatch-Waxman (a practice that is now prohibited). As noted at the end of the article below, TriCor is essentially an obsolete product, and ABT is attempting to switch users to TriLipix. The ABT-AZN JV to commercialize Certriad (#msg-38514635, #msg-38449725) is another endgame for ABT’s fenofibrate business.]
›NOVEMBER 30, 2009, 3:54 P.M. ET By KEVIN KINGSBURY AND KATHY SHWIFF
Abbott Laboratories and Laboratories Fournier SA have agreed to grant generic-drug maker Teva Pharmaceuticals Industries Ltd. the rights to the cholesterol drug TriCor no sooner than March 28, 2011.
Under some circumstances, Teva may not receive rights to TriCor's 145-milligram dose until July 1, 2012. Formulation patents on the drug, which Abbott holds in partnership with Solvay SA, don't expire for as many as 14 years.
Abbott and Fournier were sued earlier in this decade for alleged abuse of the patent system to ward off competition for TriCor from generic drug makers. Among the plaintiffs in the antitrust action was Impax Laboratories Inc. The generic drugmaker said a month ago that it had begun a challenge of TriCor patents.
The deal with Teva will end the litigation between the two companies. Abbott spokesman Kelly Morrison said the agreement "allows Abbott to maintain certainty" about when generic competition will begin.
Abbott doesn't expect generic competition outside the U.S. Those rights are held by Solvay, whose drug business Abbott has agreed to acquire for at least €4.5 billion ($6.7 billion)[#msg-41922225].
The TriCor saga dates back to the 1960s, when the drug, known generically as fenofibrate, was discovered by Fournier. The French company began selling the product in Europe in 1975, and Abbott licensed it in the late 1990s. The drug's underlying patent had expired, but Abbott patented a new way to make it.
TriCor is prescribed to help lower levels of bad cholesterol and triglycerides, which are chemicals in the blood derived from fats, and to raise good cholesterol.
But some doctors are skeptical about the benefits of TriCor. Past studies have failed to show definitively that it reduces heart attacks and related disease, and some studies have raised the possibility it could cause kidney problems. Abbott has defended the drug's efficacy and safety, saying there's no evidence it boosts the risk of kidney problems.
In October, Abbott played down the potential impact of a planned review by the European drug regulatory body of the long-term clinical benefits of certain cholesterol drugs, including TriCor. A spokeswoman said the committee will probably focus on harmonizing prescribing labels across Europe to reflect label changes recommended in 2007 by a European Union advisory body, which found the drugs' risk/benefit profile to be positive.
In the U.S., the National Institutes of Health has conducted a large study testing whether adding TriCor to the cholesterol-lowering drug simvastatin [MRK’s Zocor] is any better than simvastatin alone at improving cardiovascular outcomes in diabetics. Treatment in the NIH study ended in June, and the results are expected to be reported in early 2010.
In its latest quarterly report in October, Abbott said combined sales of TriCor and follow-up Trilipix slid 1% to $330 million.
JPMorgan analysts said the Teva deal allows Abbott more time to convert TriCor users to Trilipix, which hit the market in January[yes, of course]. Nearly one-quarter of TriCor users have switched, and the analysts expect the figure to top 50% by March 2011, when the first TriCor generics could hit the market.‹
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