Novartis says that it is evaluating the potential financial impact that sales of Teva’s generic version of the Swiss company’s hypertension treatment Lotrel will have on earnings.
Last Friday, the US Food and Drug Administration gave its approval to the Israeli-headquartered firm’s copycat version of Lotrel (almodipine/benazepril), but a US federal district court issued a temporary restraining order the next day. That court has maintained the ban on Teva’s drug until a patent infringement lawsuit is heard on May 29 but importantly it did not insist on a recall of product distributed before the restraining order was imposed.
It may have been only one day, but it is thought that Teva shipped up to three month’s supply of generic Lotrel. Furthermore the court also prevented Novartis from launching a so-called ‘authorised generic’ version of the drug, which is sold only in the USA, until the May 29 hearing. The Swiss group maintains that its Lotrel patents in the USA are valid until December 2017, saying that it “will continue to vigorously defend its intellectual property rights” against any challengers.
Novartis said that it is considering what the effect of Teva's actions could be on its full-year 2007 net sales, operating and net income results. Lotrel, which is sold only in the USA, is a big earner for the firm and its sales last year reached $1.35 billion.
Warning of kidney failure with Exjade
Meantime, Novartis and the FDA have alerted physicians to a label change for the firm’s Exjade (deferasirox) for the treatment of iron overload as a result of blood transfusions after cases of acute renal failure, some with a fatal outcome, were reported following post-marketing use.
Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their haematological disorders and there were also reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some died. However the agency noted that “the relationship of these episodes to treatment with Exjade is uncertain” and most of these patients had pre-existing haematologic disorders that are frequently associated with bone marrow failure.