Navigation Links
Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
Date:10/14/2008

REINACH, Switzerland, October 14 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI) during its meeting on 18-20 November 2008. An Advisory Committee can be requested by FDA as part of the review process of an NDA or supplemental NDA.

Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens. To date, Arpida has filed marketing applications for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections in the U.S.A., Canada and the European Union.

Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are delighted to have an opportunity to present iclaprim to leading experts in the anti-infective field and to discuss important features of our NDA with the Advisory Committee."

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 in August 2008.

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 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.

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. Results of "first-in-man" studies with AR-709 were published in March 2007.

An additional antibacterial compound, AR-2474, has demonstrated 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

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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
2. Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
3. Arpida Provides Further Comments on the Pivotal Phase III Trials
4. Arpida Invited to Present Data on Iclaprim at Scientific Conference
5. Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data
6. Facet Solutions Announces Completion of 6 Month Follow-Up in US Pilot Study
7. Quark Pharmaceuticals Announces Publication of Study on Use of siRNA against Proprietary Target for Inhibiting Tumor Growth and Sensitization of Cancer Cells to Chemotherapy
8. XTENT Announces Clinical Trial Data to be Presented at Annual Meeting of Transcatheter Cardiovascular Therapeutics Next Week
9. SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen
10. In celebration of World Hospice and Palliative Care Day, FHSSA Announces Seven New Partnerships Between U.S. Organizations and African Hospices
11. Burcon announces GRAS status for Puratein(R) & Supertein(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... Dec. 9, 2016   Hudes Laser Aesthetica ... featuring the multi-wavelength Astanza Trinity laser and Astanza ... in laser tattoo removal, IPL hair removal, pigmented ... therapy. Hudes Laser Aesthetica is setting high standards ... and promises to deliver effective, long-lasting results. ...
(Date:12/9/2016)... , Dec 9, 2016 Research and ... Market - Forecast to 2021" report to their offering. ... ... open innovative models in the pharmaceutical and biotechnology industry and ... rising government funding. Emerging markets and growing research activities in ...
(Date:12/9/2016)... DIEGO , Dec. 9, 2016 aTyr Pharma, Inc. ... discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, ... at the upcoming BMO Prescriptions for Success Healthcare Conference at the ... on Wednesday, December 14, 2016, at 4:20 p.m. ET. ... ...
Breaking Medicine Technology:
(Date:12/10/2016)... , ... December 10, 2016 , ... ... most vulnerable population in Syria’s civil war—babies and toddlers. , The situation in ... Families are experiencing bombing, facing starvation, and dying from disease. The situation is ...
(Date:12/9/2016)... Kentucky - Cincinnati, Ohio (PRWEB) , ... December ... ... in the production of miniature, folded, pharmaceutical inserts and outserts. As a ... Serialization Device. This addition will enable Flottman to individually code professional inserts ...
(Date:12/9/2016)... ... December 09, 2016 , ... Mediaplanet today announces distribution of the ... encouraging readers to sign up as an organ donor for the 123,000 people in ... An organ donor can save up to 8 saves through organ donation and enhance ...
(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia ... 1, 2017. The name change aligns the entire company with its existing ... care quality. , “We are very proud of the achievements associated with the ...
(Date:12/8/2016)... Pa. (PRWEB) , ... December 08, 2016 , ... ... Medicine Southern Chester County, a Property owned by an affiliate of Seavest, has ... square foot Penn Medicine Southern Chester County ambulatory care center (ACC) was named ...
Breaking Medicine News(10 mins):