Italy eyes €1.2 billion pharma fine
pharmafile | May 30, 2014 | News story | Sales and Marketing | Novartis, Roche, avastin, off label, wet and
Italy’s health ministry says it is looking for €1.2 billion in damages from Roche and Novartis over claims that the companies colluded to stop Roche’s cancer drug Avastin from being used by doctors to treat wet age-related macular degeneration (AMD).
Off-label prescribing of Avastin (bevacizumab) for this eye condition has been relatively common even though the drug – unlike the more expensive Lucentis (ranibuzimab), which is co-marketed by Novartis and Roche – is not approved for this licence.
But the brands are chemically similar, and by prescribing Avastin off-label health authorities have saved money. Both companies insist they have done nothing wrong: Roche says the request from the Italian authorities has ‘no basis’ while Novartis ‘strongly’ deny the allegations.
In March, Italy’s antitrust authority fined the two firms €182.5 million – although Roche and Novartis have consistently said that there is no such agreement between them.
Last month French competition authorities began their own investigation: a notice on the website of the Authorite de la Concurrence said that unannounced visits were made on 8 April to unnamed companies in France suspected of being involved in ‘anti-competitive activities’.
Documents have been removed from the offices but the Authorite declined to comment, telling Pharmafile that the procedure was ‘confidential’.
Earlier this month European Union regulators considered whether they need to take any action over the allegations.
There has been no formal move by the European Commission, but Joaquin Almunia, vice president of the EC in charge of competition issues, was quoted as saying regulators were ‘gathering information’.
The EC “will assess whether further action is needed in this area”, Almunia adds, although he would not say what the ‘precise content’ of the current investigation is.
The Avastin/Lucentis issue was the subject of a legal battle in the UK a couple of years ago, where the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) cluster was making Avastin available to patients.
The cluster decided to reverse its stance after Novartis offered Lucentis at a discounted price although the size of the price cut remains confidential.
Adam Hill
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