Italian prosecutors jump into Roche, Novartis case with fraud probe

FiercePharma file photo

After their antitrust-fighting colleagues levied $251 million in fines against Swiss drugmakers Roche ($RHBBY) and Novartis ($NVS) on allegations that they colluded to protect sales of their eye drug, Italian prosecutors are now investigating possible market manipulation and fraud, according to Reuters.

Armed with evidence gathered in the antitrust probe, the prosecutors are proceeding with their own inquiry. According to The New York Times, Italian authorities uncovered "numerous messages" between the two companies in which they discussed ways to persuade doctors and hospitals to use the pricey Lucentis, approved to treat wet age-related macular degeneration, rather than Avastin, often used off-label for the same purpose at a small fraction of the price.

Roche's U.S.-based Genentech unit developed Avastin, and Novartis owns the marketing rights outside the U.S. Many doctors in the U.S. and elsewhere choose to use the less expensive off-label option, and the companies have fought back in a variety of ways. The Italian Competition Authority alleged in a statement Wednesday that the two companies worked together to block distribution of Avastin.

Roche and Novartis said in statements to the press that they deny the allegations and will appeal the charges that sparked the fines. As for the subsequent legal investigation, sources tell Reuters that no specific executives are under investigation at this point.

This investigation is the latest wrinkle in the ongoing Avastin-vs.-Lucentis debate. Some research suggests the two treatments are equally effective, but Avastin has to be repackaged for use in the eye, and that can lead to dangerous contamination, Roche has long contended. The one issue that can't be debated, however, is cost: Italian regulators say a Lucentis injection there costs €900 (about $1,230) compared with €81 ($111) for Avastin.

Italian regulators estimate that blocking access to Avastin for use in the eye cost the country's health system €45 million ($62 million) in 2012 and could end up costing €600 million ($824 million) or more per year in the future.

- here's the Reuters story
- read more from the NYT (sub. req.)

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