BioVaxys Technology Corp. C.BIOV

BIOV FINALIZED DISTR AGRMNT FOR PAPILOCAR & ORAL IMMU..

[Humanist]

BioVaxys and Procare Health Execute US Distribution Agreement for Papilocare Gel and Oral Immunocaps
by @newswire on 19 Dec 2022, 07:00
     
VANCOUVER, British Colombia and BARCELONA, Spain, Dec. 19, 2022 /PRNewswire/ - BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") and Procare Health Iberia, of Barcelona, Spain ("Procare Health") announced today that they have finalized and executed the United States Distribution Agreement ("Distribution Agreement") for Papilocare^® and Oral Immunocaps^©. Following the binding Term Sheet executed by the two companies in early October 2022, the Distribution Agreement finalized all remaining aspects of the transaction. 
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 that supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions. 

Yann Gaslain, Founder and CEO of Procare Health Iberia commented: "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. 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." 

BioVaxys will immediately begin pursuit of regulatory approval for Papilocare^® with the US Food and Drug Administration ("FDA") and anticipates US registration as a Class II medical device.  As Immunocaps^® is an OTC supplement, BioVaxys anticipates that regulatory approval will not be required, allowing the rapid build out of sales channels and revenue generation from the product.  BioVaxys plans to begin stocking and distributing Immunocaps^© in early 2023.

As per the Term Sheet executed in October, BioVaxys and Procare Health will begin discussions on the Company's right-of-refusal in the United States for Ovosicare^® and Libicare^®, Procare Health's over-the-counter supplements to support fertility enhancement for late maternity or IVF processes and Menopausal symptoms improvements which includes low libido among women suffering menopausal changes.

Kenneth Kovan, President & Chief Operating Officer at BioVaxys said "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."

Founded in 2012, Procare Health is a leading privately held pharmaceuticals company in the Women's Health field based in Spain with several affiliates in Europe including France, Portugal, and the UK, and marketed products including Papilocare^®, Libicare^®, Palomacare^®, Idracare^®, Pronolis HD^® and Ovosicare^®.  Procare Health commercializes its products within more than 60 countries in the world via distribution agreements with well-known and established pharmaceuticals company within the Women's Health field.

Left untreated, HPV infection can lead up to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). In Procare Health's PALOMA Phase IIb clinical trial for Papilocare, which results were recently published into the Journal of Lower Genital Tract Disease, Papilocare^® showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population, with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients.

HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.¹ 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.
A "CE mark" indicates that a product and the manufacturer has been assessed by a Notify Body (as a delegation of the European Health Agency) under the new MDR EU regulation and deemed to meet EU efficacy and safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

Additionally, Procare Health has been granted the ISO 13485 Medical device certification and the MDSAP certification which recognizes the company as a validated worldwide manufacturer.