Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for women's health, announced its first preliminary product approval. The Swiss regulatory authority has stated it will grant marketing authorization for pentamycin pending minor clarifications. Pentamycin is Lumavita's proprietary anti-infective for the treatment of vaginitis caused by fungal infections, trichomonal infections and mixed bacterial flora infections. Following final approval, pentamycin will be sold in Switzerland by Lumavita's Swiss partner, Permamed AG, under the brand name Pruri-Ex. Outside of Switzerland, pending further approvals, pentamycin will be sold as FemiFect.
Vaginal infections are extremely frequent, affecting up to 10% of all women each year whose treatment generates more than 100 million prescriptions across Europe and North America. Pentamycin is a unique medicine for these patients because, unlike currently available products, it is an antibiotic with an appropriate spectrum of activity to treat all three types of infections known to cause vaginitis: fungal infections, trichomonal infections and mixed infections including bacterial infections.
Unlike some other treatments for vaginal infections, pentamycin has had no observed effect on the natural flora of the vagina. Maintenance of the vagina's natural flora is known to be an important element to the healing process following an infection. In addition, pentamycin's spectrum includes activity against pathogens resistant to current gold-standard treatments. Pentamycin is under further evaluation for its ability to reduce recurrent infections, experienced by a high proportion of sufferers and for safe administration in pregnancy.
Professor Dr E R Weissenbacher of Gynaecology and Obstetrics at the University of Munich, Germany commented, "Pentamycin will offer an important step forward in the treatment of these frequent infections which are highly distressing for patients. No approved antibiotic currently exists with sufficient activity to treat all three causes of vaginitis. Pentamycin meets this important therapeutic goal, enabling gynaecologists to treat with an effective medicine first time around."
Nicholas Benedict, CEO of Lumavita, added, "The anticipated Swiss approval of Lumavita's proprietary medicine pentamycin will be a major milestone for our young company and will be followed quickly by further regulatory submissions in more than 100 countries throughout the world. Pentamycin offers the first therapeutic breakthrough in the treatment of vaginitis for almost twenty years and the clinical benefits offered to both gynaecologists and patients are highly relevant to the medical needs still unmet by existing therapies. The early revenues from the first sales of pentamycin will help to finance Lumavita's research efforts into our second project which is under evaluation for the treatment of cervical HPV, an infection associated with virtually cent per cent of all cases of cervical cancer."
The clarifications requested by SwissMedic comprise degredation patterns and minor revisions to product specifications. These details will be supplied to SwissMedic within the coming weeks and it is anticipated that pentamycin will be launched in Switzerland thereafter.
Lumavita AG is biopharmaceutical company focusing on novel anti-infectives for women's health. Lumavita AG was founded in August 2008 and is engaged in globally targeted Development and Commercialisation activities for its proprietary product portfolio.