The agreement includes the right of first refusal in the United States for Ovosicare and Libicare
VANCOUVERBritish Columbia, October 9, 2022 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF (“BioVaxys” or the “Company”) announced today that it has signed a binding Letter of Intent (“Letter of Intent” or “Agreement”) with Procare Health Iberia, SL (“Procare Health”), of Barcelona, Spain (“Procare Health”), for the exclusive marketing and distribution in the United States of Procare Health’s lead patented product, Papilocare™the world’s first and only vaginal gel clinically proven to prevent and treat HPV-dependent cervical lesions, and Immunocaps®, an over-the-counter oral nutritional supplement that supports immune function and the vaginal microbiota to help re-epithelialize cervical lesions. As Immunocaps® is an over-the-counter supplement, BioVaxys anticipates that regulatory approval will not be required, allowing for rapid expansion of sales channels and revenue generation from the product.
In addition, the agreement grants BioVaxys a right of refusal in the United States for Ovosicare® and Libicare®over-the-counter supplements from the company Procare Healthles aimed at supporting fertility enhancement for late childbearing or IVF processes, and improvements in menopausal symptoms, which include low libido in women suffering from related changes at menopause.
Financial terms include milestone payments and royalties on sales. The companies have agreed to enter into an initial ten-year exclusivity agreement (“Distribution Agreement”) by December for Papilocare® Gel (packs of 7 and 21 cannulas of 5 ml), 2 x 40 ml and applicators, sample packs 1 x 5 ml and packs of 30 capsules Immunocaps®. Manufacturing will continue to be carried out in Spain under the responsibility of Procare Health.
Founded in 2012, Procare Health is a private pharmaceutical company, leader in the field of women’s health. The company is based in Spain with several subsidiaries in Europeof which the Francethe Portugal and the UK. Among its marketed products are Papilocare®, Libicare®, Palomacare®, Idracare®, Pronolis HD® and Ovosicare®. Procare Health markets its products in more than 60 countries around the world through distribution agreements with a well-known and established pharmaceutical company in the field of women’s health.
The Agreement follows the Letter of Intent (“LI”) signed last year, which outlines several collaborations between the two companies, including Papilocare® and the clinical development of BioVaxys’ BVX-0918, a treatment for advanced ovarian cancer. While the letter of intent initially granted BioVaxys the right of first refusal for Papilocare®today’s agreement grants BioVaxys the exclusive right to market and distribute the brand in the United States and establishes Procare Health’s marketing support for Papilocare® and Immunocaps®.
If left untreated, HPV infection usually leads to cervical cancer (World Health Organization, HPV and cervical cancer, November 11, 2020). In Procare Health’s PALOMA PhaseIIb clinical trial for Papilocare, the results of which were recently published in the Journal of Lower Genital Tract Disease, affiliated with the American Society of Cervical Pathologies (ASCCP), demonstrated consistent and significant efficacy in normalizing cervical cytology at 3 months and 6 months across the entire study population, with 50% 70% clearance of high-risk HPV at 6 months in six different international studies and over 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 deaths from cervical cancer every year.1 Papilocare® has a CE marking valid throughout the EU and is currently marketed as a class IIa medical device in Spain, Franceto PortugalItaly, Belgium, Luxemburg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria and Romania. A “CE Mark” indicates that a product has been assessed by the manufacturer and found to comply with EU requirements for safety, health and environmental protection. It is required for products manufactured anywhere in the world which are then marketed in the EU.
Under the Letter of Intent, BioVaxys will be responsible for U.S. regulatory approval for Papilocare® and provides for registration in the United States as a Class II medical device.
James Passin, Managing Director of BioVaxys, said: “We are honored to extend the terms of our partnership with Procare Health, one of Europe’s leading innovative women’s health companies, strengthening our product portfolio. health for women. »
About BioVaxys Technology Corp.
Based at Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a clinical-stage biotechnology company, registered in British Columbia, developing viral and oncology vaccine platforms as well as immunodiagnostics. The Company is advancing vaccines against SARS-CoV-2, SARS-CoV-1 and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and plans a clinical trial of its autologous cellular vaccine based on haptenized cells used in conjunction with anti-PD1 and anti-PDL-1 checkpoint inhibitors which will be first developed for stage III/stage IV ovarian cancer. A diagnostic (the CoviDTH®) is also being developed to assess the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and multiple US and international patent applications related to its cancer vaccines, viral vaccines and diagnostic technologies. Common shares of BioVaxys are listed on the CSE under the symbol “BIOV” and trade on the Frankfurt Stock Exchange (FRA: 5LB) and in the United States (OTCQB: BVAXF).
ON BEHALF OF THE BOARD OF DIRECTORS
Signed “James Passin”
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Cautions Regarding Forward-Looking Information
This press release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable Canadian and United States securities laws (including the United States Private Securities Act). Litigation Reform Act of 1995). All statements, other than statements of historical data, included in this press release, without limitation, including statements relating to the future operational or financial performance of the Company, are forward-looking statements. Forward-looking statements are often, but not always, identifiable by the use of terms such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible” and similar expressions, or statements that events, conditions or results “will”, “may”, “could” or “should” occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements reflect beliefs, opinions and projections as of the date they are made and are based on a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines and diagnostic tools, which, although considered reasonable by the Company, are inherently subject to significant commercial, economic, competitive, political and social uncertainties and contingencies, including, primarily but not limited to, the risk that BioVaxys vaccines do not prove effective and/or do not receive the required regulatory approvals. With respect to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, but not limited to, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about the ability of its products to complete the lengthy, complex and costly process of clinical trials and regulatory approval for new drug approvals required for marketing authorization in the market, the uncertainty as to whether its vaccine immunotherapy based on autologous cells can be developed into safe and effective products and, if so, whether its vaccines will be commercially accepted and whether they will be profitable, the expenses, delays, uncertainties and complications typically encountered by biopharmaceutical companies in the development phase, the financial and development under license agreements in order to protect its rights to its products and technologies, the obtaining and protection of new intellectual property rights and the absence of infringement with regard to third parties, as well as its dependence with regard to manufacture by third parties.
The Company is not responsible for updating forward-looking statements of beliefs, opinions, projections or other factors if they change, except as required by law.
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