Ipsen announced that the supplier of Increlex®’s (mecasermin [rDNA origin] Injection) active ingredient, Lonza, is facing manufacturing issues with Increlex® at its Hopkinton site (MA, USA). Lonza is working closely with the Food and Drug Administration (FDA) to address these issues. Ipsen is diligently addressing management of the shortage period to reduce its impact on the patients and their families. The supply interruption is expected in Q2 2013 in the US and in Q3 2013 in Europe and the rest of the world. Re-supply before the end of 2013 is not currently anticipated.
Ipsen confirms its 2013 guidance (specialty care drug sales growth1 between 6.0% and 8.0% year-on-year, primary care drug sales decrease1 between -8.0% and -6.0% year-on-year, recurring adjusted2 operating margin around 16.0% of sales). In 2012, Increlex® sales amounted to €28.3 million.