The News

Novexel: Positive Phase II Trial Results

23/10/2008

Novexel Reports Positive Phase II Trial Results with NXL103 in Adult Patients with Community Acquired Pneumonia

Paris, France, 23rd October, 2008 - Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces positive results from its Phase II clinical trial evaluating NXL103 in the treatment of community acquired pneumonia (CAP). NXL103 is a novel oral streptogramin antibiotic that has potent in vitro activity against certain Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) as well as the important respiratory pathogens including penicillin, macrolide and quinolone resistant strains.

The NXL103 Phase II study was a double-blind, multinational, randomized, comparative study that evaluated this novel oral antibacterial as a treatment for mild to moderate CAP. The study recruited 300 adult patients in 9 countries in both the Northern and Southern hemispheres. Patients were randomised (1:1:1) to three treatment arms: 500mg of NXL103 twice a day, 600mg NXL103 twice a day or 1,000 mg of amoxicillin three times a day for 7 days. The key endpoints of the study were the clinical outcome in the clinically evaluable population at the early follow-up visit (7 to 14 days post-therapy) and safety. In this study, both doses of NXL103 were effective, with clinical response rates similar to those seen in the amoxicillin group. For the primary efficacy analysis, response rates were 91.4% in the 500mg NXL103 group; 94.7% in the 600mg NXL103 group; and 88.5% in the amoxicillin group. NXL103 was generally well tolerated with the most frequent adverse events related to gastrointestinal intolerance. There were no serious drug-related adverse events reported in the study.

The complete results from this Phase II trial will be published in the first half of 2009. NXL103 has a spectrum of activity that indicates it has the potential to be effective in the treatment of skin and skin structure infections, including those caused by MRSA, as well as community acquired pneumonia. Novexel’s future clinical development with NXL103 is expected to focus on its potential to be used in hospitals as an oral agent for the treatment of infections caused by Gram positive organisms, including resistant pathogens such as MRSA. Currently, physicians have a very limited choice of anti-MRSA antibacterials when they wish to switch from intravenous (IV) to oral treatment, a key step prior to a patient being= discharged from the hospital.

In the second quarter of 2008 sanofi-aventis elected not to exercise its option to develop and commercialise NXL103. Consequently, worldwide rights to the NXL103 programme are retained by Novexel.

Iain Buchanan, Novexel’s CEO, commenting on the announcement said, “We are very pleased that the results from our first Phase II clinical trial with NXL103 are positive. The data from this trial confirm the efficacy of NXL103 in patients with mild to moderate CAP. Furthermore, the pre-clinical and clinical work that we have carried out to-date with NXL103 provides a compelling platform for Phase III development. We believe that with its potent activity against MRSA, NXL103 may offer physicians an important therapeutic option when they switch patients from IV to oral treatment prior to discharge from the hospital.”

For further information please contact:
Novexel
Gordon Waldron, CFO
Tel: +33 1 5714 0777
gordon.waldron@novexel.com

Citigate Dewe Rogerson
Amber Bielecka/David Dible/Nina Enegren
Tel.: +44 (0) 207 638 95 71
amber.bielecka@citigatedr.co.uk

About Novexel
Novexel is a speciality pharmaceutical company focused on the discovery and development of novel anti-bacterials designed to overcome the significant global problem of bacterial resistance. The ever increasing resistance to marketed antibiotics has led to a clear need for novel drugs that are active against multi-drug resistant bacteria. Novexel’s products are targeting the global hospital antibiotic market, which was worth an estimated $15bn in 2007 according to information derived from the IMS Midas® database. Novexel currently has two novel antibacterials in Phase II clinical development. These are the injectable beta-lactamase inhibitor, NXL104, which is being developed in combination with the cephalosporin antibiotic ceftazidime for serious Gram negative infections, and the oral streptogramin antibiotic, NXL103, for the treatment of Gram positive infections, with a focus on treatment in the hospital setting and intravenous (IV) to oral switch. Novexel has three further programmes in preclinical developm nt, NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandin antifungal agent, and NXL104 in combination with ceftaroline. This latter product is being developed by our partner, Forest Laboratories, solely for North American markets.
Novexel was created in December 2004 as an independent spin-out of the sanofi-aventis (Euronext Paris: SAN, NYSE: SNY) anti-infectives unit. Novexel has a team of 50 employees with significant experience in anti-infective research and development, who are located in Paris, France and Philadelphia, USA.