Hyloris and Purna Female Healthcare partner to develop novel women’s health product
pharmafile | February 5, 2021 | News story | Medical Communications | Hyloris, women
Hyloris Pharmaceuticals and Purna Female Healthcare (PFH), a spin-off founded by Purna Pharmaceuticals and Creafund, have entered into a partnership to develop and commercialise an innovative combination therapy for the treatment of severe and recurrent vulvovaginal candidiasis (rVVC).
PFH is a special purpose vehicle founded to exclusively develop a local topical combination formulation of the well-known antifungal Miconazole with Domiphen Bromide (MCZ-DB).
Under the terms of the agreement, Hyloris has committed to milestone related investments of up to €4.3 million in PFH, including €1.27 million at signing, and will lead the commercialisation and out-licensing activities. Hyloris owns 20% of PFH and is eligible to receive up to a maximum of 45% of the net profits generated by the company.
VVC is a vaginal fungal infection commonly caused by the yeast Candida albicans, affecting as many as one in every two women during their life. Up to 20% of VVC patients develop severe to recurrent VVC where reinfection occurs more than four times per year, and the condition can cause significant pain and distress, with an estimated economic burden from lost productivity of over $14 billion annually by 2030.
There is a high unmet need for novel treatment options in severe and rVVC as current standard of care treatments have significant drawbacks, including lack of efficacy, the development of drug resistance due to continued use, and liver toxicity.
Recent preclinical studies have demonstrated that the activity of Miconazole (MCZ), the current topical standard of care, when combined with the Miconazole potentiator Domiphen Bromide, can combat the occurrence and recurrence of mucosal biofilm-related vaginal Candida infections.
Stijn Van Rompay, CEO of Hyloris, commented: “Patients with severe and rVVC have limited effective treatment options and we believe that the novel MCZ-DB combination therapy has significant potential to help women manage this underserved condition. The strong scientific rationale and proven efficacy and safety profile of MCZ provide further upside and dramatically reduce potential development risk, time, and cost.
“We are very pleased to have entered into this agreement with Purna Female Healthcare to deliver a much-needed innovation in women’s health, demonstrating our ability to identify and reformulate known products to enhance current treatment practices.”
Darcy Jimenez
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