Arpida’s iclaprim MAA Accepted for Review by EMEA

    REINACH, Switzerland, August 21 /EMWNews/ -- Arpida Ltd.

(SWX: ARPN) 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 (SWX: ARPN) 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