French drug maker Sanofi recalls epinephrine injectors
02 Nov 2015
French drug maker Sanofi said Thursday that a recall of hundreds of thousands of epinephrine injectors used for treating severe allergic reactions might shave off €100 million off its bottom line.
According to Sanofi, the financial impact of the recall of Auvi-Q and Allerject injectors in the US and Canada was an initial estimate, and the final amount would be worked out in the fourth quarter. The injectors were recalled Wednesday, as they might not deliver the correct dose.
Sanofi further reported that its third-quarter net profit and sales increased even as its key diabetes treatment Lantus saw falling sales.
Lantus, Sanofi's top product, is the world's third best-selling medicine, with 2014 sales of $12.4 billion, according to UK research firm GlobalData.
According to Sanofi, it expected global diabetes sales over 2015-2018 to fall between 4 per cent and 8 per cent annually.
Lantus also faced competition from a cheaper remedy, that could go on sale in the US late next year, after Sanofi settled a lawsuit that allowed rivals Eli Lilly and Co and German drugmaker Boehringer Ingelheim GmbH to sell their version starting 15 December, 2016.
According to the French drug and vaccine maker it had received 26 reports of malfunctions with the injectors. The FDA said, if people were experiencing a serious allergic reaction and did not receive the correct dose, there could be significant health consequences including death.
In response to the recall, Mylan, maker of the EpiPen epinephrine auto-injector, issued a statement noting that its products were not affected by the recall and were now available for patients who needed an auto-injecting epinephrine in case of anaphylaxis.
Auvi-Q comes packed with two active devices and one trainer device in a corrugated box, and is distributed throughout the US through wholesalers, pharmacies and hospitals.
According to the Paris-based company, it had kept the Food and Drug Administration abreast of the recall. Auvi-Q was approved by the FDA in August 2012.