Gedea Biotech granted European Patent for the formulation of its vaginal pHyph tablet for women with vaginal infections
- Further strengthens Gedea Biotech’s broad patent portfolio
- pHyph has demonstrated a superior safety profile, a cure rate in line with antibiotics and a lower infection recurrence rate
- Additionally, unlike antibiotics, pHyph will not promote antimicrobial resistance
Lund, Sweden, September 13, 2023. Swedish women’s health company Gedea Biotech announced today that the European Patent Office (EPO) has granted the company´s patent application no. 20715885.8 for the formulation of the active ingredient, Glucone-delta lactone (GDL) in pHyph™, the company’s vaginal tablet for treatment of vaginal infections. The patent number is 3976000 and the patent runs until 2040. Glucono-delta lactone (GDL) in pHyph™ is a well-documented substance with a low risk for contributing to antimicrobial resistance.
This patent is part of the company’s third patent family, thus broadening the patent protection related to treatment of vaginal infections. Gedea Biotech’s already granted patents include patents for treatment of fungal infections in USA, Japan, Europe, China, South Korea, Australia, Mexico, Ukraine, Israel, Chile, Hong Kong, South Africa and Singapore and patents for treatment and prevention of bacterial vaginosis in USA, Singapore, Mexico and Ukraine.
Recurring vaginal infections affect at least 400 million women annually around the world and can be caused by either bacteria or fungi, although bacterial vaginosis is the most common vaginal infection in women of reproductive age. The severity varies from mild to complicated and can lead to more severe conditions such as deep infections in the pelvis and increased risk of pre-term birth. It is often recurring, especially after antibiotic treatments, requiring repeated medication.
Annette Säfholm, Gedea Biotech’s CEO comments:
“The new patent strengthens Gedea’s patent protection in Europe, expected to be the first market for launch, and with granted patents for treatment of vaginal fungal infections in all major markets and for treatment of and protection against bacterial vaginosis in USA, we are approaching a very strong patent protection position. We are also planning additional clinical studies to support our up-coming application for CE-marking in Europe.
In two previous clinical studies, the most recent being a placebo-controlled trial including 152 patients, conducted at several sites in the UK and Sweden,
Gedea Biotech has demonstrated good results for pHyph in treatment of bacterial vaginosis, with a cure rate in line with antibiotics on the market but with superior safety profile and lower recurrence rate.
For more information
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com
Ton Berkien, Chairman, Gedea Biotech
Telephone: +46 70- 791 49 54
Email: ton.berkien@gedeabiotech.com
About pHyph
The vaginal tablet, pHyph will treat bacterial vaginosis (BV) and prevent recurrence by promoting a healthy vaginal microbiome, restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during BV under which the infectious bacteria begin to thrive. These mechanisms of action, together provide a beneficial environment for the healthy vaginal microbiome. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive. A clinical cure rate for BV on par with antibiotics on the market, has been proven in two phase 2 trials, with a superior safety profile and without causing secondary VVC infections as antibiotics do.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that both prevents and treats bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. Gedea Biotech was founded in 2015 in Lund, Sweden.
