MerLion Pharmaceuticals initiates Phase I clinical study of Friulimicin B, a novel lipopeptide antibiotic

Singapore, 2nd July 2007 - MerLion Pharmaceuticals (MerLion) announces today the commencement of Phase I clinical trials of the novel lipopeptide antibiotic, friulimicin B (friulimicin). The drug candidate is active against a broad spectrum of gram positive multi drug resistant, invasive pathogens and is the only  experimental antibiotic of its type in clinical trials.

In the last twenty years there has been a dramatic rise in the proportion of bacteria that are resistant to existing antibiotics, even to those therapies used as drugs of last resort. Examples of these so-called ‘superbugs’ are methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). This period has coincided with an equally dramatic fall in the rate of introduction of new anti-bacterial drugs; only two new classes of such drugs being introduced in the past thirty years.

Dr Tony Buss, CEO of MerLion said “Over 70% of bacterial infections acquired in hospital are resistant to at least one front line antibiotic. Bacterial resistance is a major global health problem that is increasing the severity of disease and rates of mortality. Consequently, there is an urgent need to develop antibiotics such as friulimicin that have new mechanisms of action.”

Dr Harald Labischinski, CSO of MerLion said “Friulimicin acts by a novel, cell wall directed, mechanism not replicated by any antibiotic either marketed or in clinical development. This has a major impact upon the potential for direct cross-resistance. In contrast to the lipo(depsi)peptide daptomycin, friulimicin is also active in the lung environment and, thus, can be useful in a wide range of indications.”

Friulimicin is a naturally occurring compound, derived from a microbe found in soil, and is produced by fermentation. It has been formulated for intravenous administration and will be tested for kinetics and safety in healthy volunteers. The ability of circulating concentrations of the compound to kill drug resistant bacteria in the laboratory ex vivo will also be evaluated and is a biomarker for subsequent clinical efficacy.

Contact: Mr. Chris Molloy, Chief Operating Officer
Tel: +65 6829 5600
E-mail: enquiry@merlionpharma.com
Visit MerLion’s new website: http://www.merlionpharma.com

For Editors

Fact File :
• Bacterial infections kill more than 17 million people worldwide every year.
• 22 million people in the USA are diagnosed with pneumonia each year (NIH)
• 4.5% of dialysis patients in the USA contract invasive MRSA (Datamonitor 2007)
• The only other lipo(depsi)peptide antibiotic in clinical use is Cubicin® (daptomycin for injection), which was launched in 2003 and which represents the most successful IV antibiotic launch, in dollar terms, in U.S. history. (http://www.cubist.com/)

Web resources

MRSA

www.cdc.gov/ncidod/dhqp/ar_mrsa.html
www.mrsa.uk.com
www.mrsasupport.pwp.blueyonder.co.uk/
www.mayoclinic.com/health/mrsa/DS00735

VRE
www.cdc.gov/ncidod/dhqp/ar_vre.html
www.cdc.gov/ncidod/eid/vol7no2/rice.htm
www.cinetwork.com/otero/vre.html

About MerLion Pharmaceuticals Pte Ltd

MerLion Pharmaceuticals is a privately held international drug discovery and development company headquartered in Singapore. The company focuses internal R&D efforts on anti-infectives and maintains a leadership position in natural products drug discovery. MerLion has a balanced portfolio of assets that includes several clinical stage antibiotic candidates, a unique patent position in the area of bacterial virulence, innovative screening approaches and access to the proprietary discovery technologies of its many risk-share partners. MerLion was recently identified by Fierce Biotech, a leading industry journal, as one of the world’s most promising biotechnology companies.