Innovation in anti-infectives

Pipeline

Overview

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 systemic absorption due to a large molecule size
  • Resistance: No 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 making FemiFect an ideal first treatment choice for empirical use in vaginitis. FemiFect is also being studied to assess its effect on reducing the risk of recurrence after the initial infection.

Current treatment options available for vaginitis result in high failure rates which contribute to strong medical demand for innovative treatment options. Up to 10% of adult women suffer from vaginitis in any one year, causing much distress and discomfort. 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 approved in Switzerland and Lumavita will be submitting for marketing approval of FemiFect across 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.

SPK-601

SPK-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, SPK-601 has antiviral properties and is being investigated in Phase I for the treatment of human papilloma virus (HPV) and for the treatment of herpes simplex virus (HSV).

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.

SPK-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 has a low potential for inducing drug resistance.

The estimated peak sales value of SPK-601 for HPV may be between USD 300 million to USD 500 million, and for HSV may be between USD 50 million to USD 100 million. SPK-601 may also have the potential for treating other viruses such as H5N1, SARS and CMV.

SPK-601 has the additional property of being an inhibitor of protein kinase C (PKC) and may have the potential to be used therapeutically in additional areas of high medical need such as oncology.

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

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