|
Arpida today announced that it has submitted a Marketing Authorisation Application (MAA) for intravenous iclaprim for the treatment of complicated Skin and Soft Tissue Infections (cSSTI) to the European Medicines Agency (EMEA)
Reinach, Switzerland | July 28, 2008 | Arpida Ltd. (SWX: ARPN) today announced that it has submitted a Marketing Authorisation Application (MAA) for intravenous iclaprim for the treatment of complicated Skin and Soft Tissue Infections (cSSTI) to the European Medicines Agency (EMEA). Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens.
The iclaprim MAA contains data from 15 clinical studies, including two well-controlled multinational pivotal Phase III trials (ASSIST-1 and ASSIST-2, in which approximately 1,000 patients were treated). Patients enrolled in the Phase III trials exhibited a high incidence of methicillin-resistant Staphylococcus aureus (MRSA) as causative pathogen. In both of these two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint of non-inferiority as compared to linezolid. In the studies, iclaprim was well-tolerated with a safety profile which compared favourably with the comparator in the treatment of patients with cSSTI.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: “We are very pleased with the timely submission of the MAA in Europe. Iclaprim is now under regulatory review both in the USA and in the European Union (EU). According to estimates of the European Centre for Disease Prevention and Control, about three million people per year catch a healthcare-associated infection in the EU, of whom approximately 50,000 die. We strongly believe that iclaprim, if approved, could help to combat this serious and increasing assault by resistant pathogens causing serious and life-threatening hospital infections.”
In addition to the cSSTI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II clinical evaluation. Moreover, an oral formulation of iclaprim is currently in a Phase II clinical trial in cSSTI as a potential step-down therapy following initial intravenous treatment.
SOURCE: Arpida Ltd. |
