BioVaxys Technology Corp. (CSE:BIOV, OTCQB:BVAXF) told investors it has now finalized and executed the previously announced US distribution agreement struck with private Spanish pharma group Procare Health to market Papilocare and Oral Immunocaps.
Developed by Procare Health, Papilocare is the world's first and only patented vaginal gel product with clinical evidence to prevent and treat HPV-dependent cervical lesions.
Immunocaps, which can be used on its own or together with Papilocare, is an oral over-the-counter nutritional supplement, which supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions.
"We are delighted to have been selected by Procare Health to market Papilocare and Immunocaps in the US, and together with Procare Health we look forward to playing a major role in the treatment of cervical lesions caused by HPV and what we hope is an accompanying reduction in cases of cervical cancer," said Kenneth Kovan, president and chief operating officer (COO) at BioVaxys.
READ: BioVaxys Technology signs exclusive distribution deal for cervical lesion treatments from Spain-based Procare Health
The company said it will immediately pursue regulatory approval for Papilocare with the US Food and Drug Administration (FDA) and anticipates US registration as a Class II medical device.
BioVaxys said it anticipates that regulatory approval will not be required for Immunocaps as it is an OTC supplement, adding that it plans to begin stocking and distributing Immunocaps in early 2023.
"We are delighted with this agreement, and if Papilocare is approved by the FDA, to be able to provide access to millions of American women to a new treatment for cervical lesions caused by HPV," said Yann Gaslain, the CEO of Procare Health Iberia.
"Papilocare is already approved in Europe and is available in 46 countries worldwide. In several clinical trials involving more than 600 patients, Papilocare showed consistent and significant efficacy in normalizing cervical cytology at three months and at six months in the total study population with 50% to 70% of High-Risk HPV clearance at six months," he added.
Left untreated, HPV infection can lead to cervical cancer. Papilocare has a CE mark valid for the entire EU and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, the UK, Germany, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, Romania, Greece, Balkans, Ukraine, Mexico, Colombia, Vietnam, and Kenya.
According to the term sheet executed in October this year, BioVaxys and Procare Health will also begin discussions on the former's right-of-refusal in the US for Ovosicare and Libicare, Procare Health's over-the-counter supplements to support fertility enhancement for late maternity or IVF processes and Nenopausal symptoms improvements, which includes low libido among women suffering menopausal changes.
Vancouver- based BioVaxys Technology is a clinical-stage biotech firm that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.
Contact the author at giles@proactiveinvestors.com