August 21, 2008
Arpida’s Iclaprim MAA Accepted for Review By EMEA
REINACH, Switzerland, August 21 /PRNewswire-FirstCall/ -- Arpida Ltd. today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim. Arpida is seeking approval of intravenous iclaprim in the European Union for the treatment of complicated Skin and Soft Tissue Infections (cSSTI). 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: "Iclaprim is under regulatory review at the major health authorities on both sides of the Atlantic. We are steadily continuing our progress towards our goal of launching intravenous iclaprim, thereby providing healthcare professionals with a new option in treating serious skin 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 cSSSI as a potential step-down therapy following initial intravenous treatment.
About Arpida Ltd.
Arpida is a biopharmaceutical company headquartered in Reinach, Switzerland with operations in Switzerland and the USA. It focuses on the discovery, development and commercialisation of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial under regulatory review and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The clinical programme for the first indication, complicated skin and skin structure infections (cSSSI), has been completed. The submission of the NDA to the US FDA was completed in March 2008. The FDA has defined that the Prescription Drug User Fee Act (PDUFA) goal date will be 16 January 2009. Arpida submitted a Marketing Authorisation Application for intravenous iclaprim with EMEA in July 2008. EMEA notified that it had accepted the MAA for review on 21 August.
In May 2008, Arpida announced the enrolment of the first patients in a Phase II 'intravenous-to-oral' switch trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, but also as an oral formulation, allowing early patient discharge followed by outpatient treatment. This switch could be a valuable instrument in reducing healthcare costs and enhancing patient comfort.
In December 2007, Arpida announced the enrolment of the first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
Arpida's fourth most advanced antibiotic programme, AR-709, targets upper and lower respiratory tract infections acquired in the community setting. AR-709 exhibited potent activity against a large panel of pneumococcal clinical isolates including those resistant to currently used drugs. Promising results of "first-in-man" studies with AR-709 were published in 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept. AR-2474 has been shown to be effective in eradicating pathogens in preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative antifungal therapy (TLT) which is in Phase III clinical trials in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
Contacts: Dr Jurgen Raths, President and CEO Harry Welten, MBA, CFO and Senior Vice President Paul Verbraeken, Head of Corporate Communications Tel: +41-61-417-96-60 Tel: +41-61-417-96-65 Tel: +41-61-417-96-83
CONTACT: Contacts: Dr Jurgen Raths, President and CEO, Harry Welten,MBA, CFO and Senior Vice President, Paul Verbraeken, Head of CorporateCommunications, Tel: +41-61-417-96-60, Tel: +41-61-417-96-65, Tel:+41-61-417-96-83