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The Medicines Co.'s "Warty" Drug Strategy Flops

The Medicines Co.'s strategy of turning trash to treasure took a blow this week as the company discontinued two Phase III trials of platelet inhibitor cangrelor due to lack of efficacy.

Cangrelor was an AstraZeneca cast-off that Medicines acquired in 2003. The two Phase III trials in patients underoing percutaneous coronary intervention (a.k.a angioplasty) were designed to support a launch in 2010, and analysts had estimated the drug could bring in $300 million annually.

But an interim analysis determined that neither of the two massive trials -- which were well on their way toward completing enrollment of more than 15,000 patients -- was likely to meet its endpoint.

Cangrelor isn't necessarily dead. Medicines plans to study the drug in a subset of needier patients who can't take oral anti-clotting drugs like Plavix (clopidogrel) or who have to stop taking Plavix ahead of surgery. Since cangrelor is short-acting and intravenous, it may yet find a niche.

But hopes of a hefty launch in 2010 are dashed, and that's bad news for the company on several fronts.

First, Medicines' anticoagulant Angiomax (bivalirudin) goes off patent in 2010 thanks to a lawyer who missed a patent filing deadline that would have protected the drug until 2014. Only new legislation can fix the faux pas, and Medicines' efforts to lobby Congress have thus far gotten the cold shoulder. BioWorld Today reported that Angiomax is expected to pull in $425 million to $445 million in revenue this year, but analysts predict sales will get slashed in half in 2011.

But besides the replacement revenue Medicines was counting on from cangrelor, the drug's failure puts added pressure to perform on the company's only other late-stage asset, the antibiotic oritavancin. And like cangrelor, oritavancin is a big pharma cast-off.

Oritavancin was passed from Eli Lilly to Intermune to Targanta Therapeutics before landing with Medicines. Targanta's bid for FDA approval in complicated skin and skin structure infections was met with a complete response letter asking for another Phase III trial.

When Medicines announced its acquisition of Targanta during the J.P. Morgan Healthcare conference in January, chairman and CEO Clive Meanwell said he was "not blind to the warts on this drug." He said Medicines had looked at oritavancin when Eli Lilly was selling it and again when Intermune put it on the table, but he thought Targanta had cleaned up some of the drug's problems, and the price was right.

Medicines is planning a confirmatory Phase III trial of oritavancin this year, hoping to prove it can turn at least one warty toad into a prince.

Frog Prince courtesy of Flickr user jennifer.barnard, CC 2.0

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