On October 6, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has executed a binding Term Sheet ("Term Sheet" or "Agreement") with Procare Health Iberia, S.L. ("Procare Health"), of Barcelona, Spain ("Procare Health"), for exclusive marketing and distribution in the United States of Procare Health’s leading patented product, Papilocare, the world’s first and only vaginal gel product with clinical evidences to prevent and treat HPV-dependent cervical lesions, and for Immunocaps, an oral over-the-counter nutritional supplement that supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions (Press release, BioVaxys Technology, OCT 6, 2022, View Source [SID1234621784]). As Immunocaps is an OTC supplement, BioVaxys anticipates that regulatory approval is not required, allowing the rapid build out of sales channels and revenue generation from the product.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In addition, the agreement gives BioVaxys 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.
Financial terms include milestone payments and royalties on sales. The companies have agreed to complete an initial ten-year duration exclusive supply and distribution agreement ("Distribution Agreement") by December for Papilocare Gel (packs of 7 and 21 5ml cannulas), 2x40ml and applicators, packs of 1x5ml samples, and 30 capsule packs of Immunocaps. Manufacturing will remain in Spain under Procare Health.
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, with 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.
The Agreement follows the Letter of Intent ("LOI") signed last year outlining several collaborations between the two companies, including Papilocare and the clinical development of BioVaxys’ BVX-0918 for late-stage ovarian cancer. Whereas the LOI had originally granted BioVaxys right of first refusal for Papilocare, today’s agreement grants BioVaxys exclusive right to market and distribute the brand in the United States and establishes marketing support from Procare Health for Papilocare and Immunocaps.
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 PhaseIIb clinical trial for Papilocare, which results were recently published into the Journal of Lower Genital Tract Disease, which is affiliated with the American Society of Cervical Pathologies (ASCCP), 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, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, and Romania. A "CE mark" indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
Under the Term Sheet, BioVaxys will have responsibility for US regulatory approval for Papilocare and anticipates US registration as a Class II medical device.
James Passin, the CEO of BioVaxys, stated, "We are honored to expand the terms of our partnership with Procare Health, one of Europe’s leading innovators in women’s healthcare, further strengthening our women’s healthcare product pipeline."