Arpida Press Releases from 2008

Arpida’s Board of Directors has unanimously approved the full implementation of the previously announced measures for significantly reducing costs to focus on iclaprim. As a result, the company gains the time needed to consider and develop all strategic options.

Reinach, Switzerland, 16–12–2008 – Arpida concentrates all future activities around iclaprim. To this end, the Board of Directors has approved a comprehensive set of measures reducing all non-core activities. Key elements of the action plan to reduce costs include:

• the immediate reduction of the workforce by three-quarters down to 20 employees
• the stop of the Phase II iclaprim iv trial in HAP/VAP/HCAP (pneumonia) with immediate effect
• the review of the TLT-programme and the stop of enrolment into the ongoing Phase III trial in onychomycosis (nail infection).

Reinach, Switzerland, November 20, 2008 – Arpida (SWX: ARPN) announced today that the Anti-infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 17 to 2 against the approval of intravenous iclaprim, an antibiotic currently in development for the treatment of patients with complicated skin and skin structure infections (cSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Iclaprim also achieved high eradication rates for the most common pathogens, including methicillin-resistant Staphylococcus aureus (MRSA)

Reinach, Switzerland, 26 October 2008 – Arpida (SWX: ARPN) today presented the combined results from two pivotal Phase III clinical trials at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual meeting in Washington, DC. In these studies, intravenous iclaprim, a novel antibiotic, showed high clinical cure rates which were similar to those of the comparator drug, linezolid, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). In addition, iclaprim was well-tolerated with a safety profile that compared favorably to linezolid. A New Drug Application for intravenous iclaprim in cSSSI will be discussed at the meeting of the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee on 20 November 2008.

Reinach, Switzerland, 23 September 2008. Arpida Ltd. (SWX: ARPN) today announced the completion of enrolment in the Phase II ‘intravenous-to-oral’ switch trial with oral iclaprim in patients with complicated Skin and Skin Structure Infections (cSSSI).

Reinach, Switzerland, 21 August 2008. 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.

Reinach, Switzerland, 28 July 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.

Reinach, Switzerland, 16 May 2008. Arpida Ltd. (SWX: ARPN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI). Arpida completed the submission of the NDA to the agency in March 2008. FDA has assigned a standard ten month review to the iclaprim NDA and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be 16 January 2009.

Reinach, Switzerland, 25 April 2008. Arpida Ltd. (SWX: ARPN) today announced that Dr Jürgen Raths will succeed Dr Khalid Islam as Chief Executive Officer. Dr Jürgen Raths commands extensive knowledge in the commercialisation of drugs for the treatment of severe infections in hospitals and has successfully built and lead the European Critical Care sales, medical and marketing organisation of Eli Lilly and Company for many years.

Extensive data to be presented at the upcoming ECCMID conference

Reinach, Switzerland, 11 April 2008. Further to the press release published on 9 April, Arpida Ltd. (SWX: ARPN) today elaborates on some additional elements of the clinical programme with intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI). Extensive data on ASSIST-1 has been presented at last year’s ICAAC and IDSA meetings. Data on ASSIST-2 will be presented at the upcoming 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) which takes place in Barcelona, 19–22 April 2008.

THIS ANNOUNCEMENT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION
IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN

• English
• German
• French

Reinach, Switzerland, 22 January 2008. Arpida Ltd. (SWX: ARPN) announced today that patient screening for enrolment into the pivotal Phase III study with the TLT treatment in onychomycosis has been initiated and is progressing at a very good rate.