Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim

REINACH, Switzerland, May 26/PRNewswire-FirstCall/ -- Arpida Ltd (SWX: ARPN) today announced the enrolment of the first
patients into the Phase II "intravenous-to-oral" switch trial with oral
iclaprim in complicated Skin and Skin Structure Infections (cSSSI). Enrolment
remains on track for completion in 2008.

The key objective of the study is to assess the clinical efficacy of an
oral capsule formulation of iclaprim as step-down therapy in comparison with
a full course of intravenous (i.v.) treatment with vancomycin in the
treatment of cSSSI. The primary endpoint will be the clinical cure rate at
the Test-of-Cure (TOC) visit. Secondary objectives include bacteriological
outcomes as well as safety and tolerability.

This Phase II trial is designed as a multi-centre, double-blind,
double-dummy comparative study. Patients suffering from cSSSI receive i.v.
vancomycin for the first two days of treatment and are then randomised to
either continue to receive i.v. vancomycin or to be switched to oral iclaprim
for eight additional days. A total of 60 patients will be randomised for this
study.

Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "Among
the hospital anti-MRSA drugs that are currently in filing or late-stage
development, only iclaprim shows oral bioavailability allowing clinical
development and consequently offers the potential for intravenous-to-oral
switch therapy. We consider the oral switch therapy to be an important option
addressing an increasing therapeutic need. It allows patients to be sent home
earlier, thereby increasing patient comfort, reducing the risk of contracting
additional infections and lowering costs for the healthcare system. We feel
the oral switch therapy could add significant potential to the intravenous
formulation."

About Arpida Ltd.

Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities in Reinach, Switzerland and in the USA. It focuses on the
discovery and development 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.

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).

In January 2008, the US FDA granted authorisation to progress oral
iclaprim into 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.

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
March 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.

For further information please contact:


Arpida

Dr Jurgen Raths, CEO
Tel: +41-61-417-96-60

Harry Welten, MBA, CFO and Senior Vice President
Tel: +41-61-417-96-65

Paul Verbraeken, Head of Corporate Communications
Tel: +41-61-417-96-83

Source: Arpida Ltd.

Arpida: Dr Jurgen Raths, CEO, Tel: +41-61-417-96-60; Harry Welten, MBA, CFO and Senior Vice President, Tel: +41-61-417-96-65; Paul Verbraeken, Head of Corporate Communications, Tel: +41-61-417-96-83


2008-05-26 07:33:04 0370047 PRNEWSWIRE

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