FemiFect®

FemiFect® (pentamycin) is the first broad-spectrum antibiotic approved to treat all three of the most common infections known to cause vaginitis: bacteria, fungi and protozoa. Due to the specific molecular structure of pentamycin, FemiFect has several unique properties that clearly differentiate it from existing products:

• Broad spectrum: Effective against all major pathogens involved in vaginitis
• Safety profile: No detectable systemic absorption due to a large molecule size
• Resistance: No recorded development of resistance reported to date

Clinical trials in more than 1300 patients have shown that FemiFect is effective in treating the pathogens most often responsible for vaginitis, is well tolerated and has no significant side effects. Its broad spectrum of activity, the lack of resistance and the potential to leave intact the body`s natural flora, contribute to FemiFect having the potential to be a first-line treatment for vaginitis. FemiFect is also being studied to assess its effect on reducing the risk of recurrence (currently 40%) after the initial infection. Femifect has a spectrum of activity covering infections caused by pathogens resistant to standard treatments of vaginitis, and in addition is under investigation for safety in pregnancy.

Up to 10% of all adult women suffer from vaginitis in any one year, causing much distress and discomfort. Current treatment options available for vaginitis result in high failure rates which contribute to strong medical demand for innovative treatment options. In up to 40% of women treated, infections recur within 3 months. This recurrence is not prevented by currently available therapies.

With up to 110 million prescriptions written annually worldwide for vaginitis, the market is valued at USD 2.5 billion. FemiFect, a vaginal tablet, is awaiting approval in Switzerland and Lumavita will be submitting for marketing approval in many countries of the world.

Lumavita is investigating further ways to improve how FemiFect can be used by doctors and patients to cure vaginitis. A Phase IIb development programme is underway in which alternative doses of pentamycin are being tested in shorter treatment courses. This Phase IIb programme is targeted at registration of pentamycin in the EU and in North America.

LMV-601

LMV-601 is the first in a new class of drugs known as PC-PLC inhibitors¹. Discovered at the prestigious German Cancer Research Center (DKFZ) in Heidelberg, LMV-601 has antiviral properties and is being investigated in late-stage pre-clinical development for the treatment of human papilloma virus (HPV).

HPV can be prevented through vaccination but vaccines cannot help patients who are already infected with the virus. The WHO estimates that the world prevalence of the infection is between 9% and 13% of the adult population. HPV infection is the most commonly diagnosed sexually transmitted disease in the USA, where between 24 million and 40 million people are infected. It has been estimated that up to 25% of US women aged 14 to 59 are already infected with HPV².

LMV-601 has a novel mechanism of action that blocks both viral DNA replication and viral gene expression through the inhibition of PC-PLC. Unlike other anti-infectives it has a low potential for inducing drug resistance.

LMV-601 is estimated to reach blockbuster sales status with its anticipated dominance of the HPV infection market.

¹ phosphatidylcholine-specific phospholipase C inhibitors
² Dunne E. et al., Journal of the American Medical Association Vol 297 No. 8, February 2007.