BioVaxys executes agreement for US marketing and distribution for 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 to help re-epithelialization of cervical lesions.
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BioVaxys Technology Corp. has executed a binding Term Sheet with Procare Health Iberia, S.L. of Barcelona, Spain, for exclusive marketing and distribution in the US 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.
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.
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 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.
Left untreated, HPV infection can lead up to cervical cancer. 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. ■
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