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FDA reviewer backs approval of TMC's cangrelor

Claims it offers a small benefit over Sanofi’s Plavix

FDA headquarters White Oak 

The Medicines Company (TMC) looks on course finally to get approval for its intravenous antiplatelet drug cangrelor in the US after a marathon phase III development programme extending back to 2006.

Cangrelor will be reviewed by an FDA advisory committee tomorrow, but briefing documents published ahead of the panel suggest the agency's reviewer is in favour of approval of the drug, having turned it down last year with a request for more data.

Cangrelor is a P2Y12 inhibitor - in the same class as AstraZeneca's Brilinta (ticagrelor) and Daiichi Sankyo/Eli Lilly's Effient (prasugrel) - and like its counterparts is aiming to tap into the multibillion-dollar market formerly occupied by Sanofi's Plavix (clopidogrel) which lost patent protection in 2012. 

The FDA now concludes that cangrelor offers a small benefit compared to clopidogrel when used second-line to reduce thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) such as angioplasty and stenting.

The briefing document supports use of the drug when an oral P2Y12 inhibitor is not suitable and when glycoprotein IIb/IIIa receptor antagonists such as abciximab or eptifibatide are not being considered.

Earlier this year the European Commission approved cangrelor in the EU - where it will be sold as Kengrexal - for the reduction of thrombotic cardiovascular events in adults with coronary artery disease. 

However, for TMC the delay in bringing cangrelor to market and a narrower indication than originally proposed will likely prove costly, particularly as the company is facing the threat of generic competition to its already-marketed anticoagulant and biggest seller Angiomax (bivalirudin) in the US. 

Angiomax is also used in the PCI setting and TMC has been hoping to promote cangrelor as a companion product to its biggest brand, although this will be less effective if generic alternatives are available and there are already signs of weakness in its flagship brand. 

Last week, the company said it expected first-quarter revenues from Amgiomax to be in the $97m-$105m range, compared to $156m in the first quarter of 2014, which it suggested "reflects uncertainty regarding the product's patent exclusivity in the US past June 2015."

Meanwhile, after a slow start caused in part by an investigation into the trial underpinning its approval, Brilinta is now gaining momentum with sales rising 70% last year to reach $476m, while Lilly reported Effient sales of more than $500m, up around 3%. 

Additional competition in the category will also come from Merck & Co's first-in-class protease-activated receptor-1 (PAR-1) antagonist Zontivity (vorapaxar) - which was cleared for marketing in the US last year, although the prospects for this drug have been held back by a risk of intracranial haemorrhage (ICH) detailed on its label.

Analysts had at one point been predicting sales of cangrelor could reach upwards of $500m, but expectations are now more modest with estimates typically in the $100m-$200m range.

Article by
Phil Taylor

14th April 2015

From: Sales

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