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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") today announced that they have completed and executed the US Distribution Agreement ("Distribution Agreement") for Papilocare® and Oral Immunocaps©. Following the binding Term Sheet executed by the two companies in early October 2022, the Distributorship 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 alone or in conjunction with Papilocare®, is an over-the-counter oral 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 give millions of American women access 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© demonstrated consistent and significant efficacy in normalizing cervical cytology at three months and at six months in the total study population with 50% to 70% clearance of high-risk HPV at six months."
BioVaxys will immediately begin seeking regulatory approval for Papilocare® with the US Food and Drug Administration ("FDA") and anticipates registration in the US as a Class II medical device. Since Immunocaps® is an over-the-counter supplement, BioVaxys anticipates that regulatory approval will not be required, allowing for the rapid creation of sales channels and revenue generation from the product. BioVaxys plans to start stocking and distributing Immunocaps© in early 2023.
Pursuant to the term sheet executed in October, BioVaxys and Procare Health will begin discussions regarding the Company's right of refusal in the United States for Ovosicare® and Libicare®, Procare Health's over-the-counter supplements to support the improvement of fertility for late childbearing or IVF processes and improvements in menopausal symptoms, including low libido among women undergoing menopausal changes.
Kenneth Kovan, President and COO of 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 an important role in the treatment of cervical lesions caused by HPV and what we hope will be a concomitant reduction in cases of cervical cancer.
Founded in 2012, Procare Health is a leading private pharmaceutical company in the field of women's health with headquarters in Spain and several subsidiaries in Europe, including France, Portugal and the United Kingdom, and markets products such as 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 well-known and established pharmaceutical companies in the field of Women's Health.
If left untreated, HPV infection can lead to cervical cancer (World Health Organization, HPV and Cervical Cancer, November 11, 2020). In Procare Health's PALOMA Phase IIb clinical trial for Papilocare, the results of which were recently published in the Journal of Lower Genital Tract Disease, Papilocare® showed consistent and significant efficacy in normalizing cervical cytology at 3 and 6 months. months in the total study population, with 50% to 70% clearance of high-risk HPV 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 throughout the EU and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, United Kingdom, Germany, Belgium, Luxembourg, Lithuania, Latvia, Poland, the Czech Republic, Hungary, Bulgaria, Romania, Greece, the Balkans, Ukraine, Mexico, Colombia, Vietnam and Kenya.
A "CE mark" indicates that a product and the manufacturer have been assessed by a notification body (such as a delegation from the European Health Agency) under the new EU MDR regulation and are found to meet the requirements for efficacy and safety, health and environmental protection of the EU. It is required for products manufactured anywhere in the world that are then placed on the market in the EU. Additionally, Procare Health has been awarded ISO 13485 Medical Device Certification and MDSAP Certification which recognizes the company as a globally validated manufacturer.
About BioVaxys Technology Corp.
Headquartered in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered clinical-stage biotechnology company developing platforms for viral and oncology vaccines, as well as immunodiagnostics. The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a sarbecovirus vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its used haptenized autologous cell vaccine. in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors to be initially developed for stage III/stage IV ovarian cancer. Also in development is CoviDTH™, a diagnostic 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, antiviral vaccines and diagnostic technologies. BioVaxys common shares are listed on the CSE under the ticker symbol "BIOV" and are also listed on the Frankfurt Stock Exchange (FRA: 5LB) and in the US (OTCQB: BVAXF).
Signed "James Passin"James Passin, CEO 1 646 452 7054
Cautionary Statements Regarding Forward-Looking Information
This press release includes certain "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of applicable Canadian and United States securities law, including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements herein relating to the Company's future operating or financial performance, are forward-looking statements. Forward-looking statements are often, but not always, identified by words 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. No guarantee can be made that such statements will 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 the beliefs, opinions and projections as of the date the statements 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, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies, including, primarily, but not limited to, the risk that BioVaxys vaccines and diagnostic tools do not prove to be 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 biotech products, including, but not limited to, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty as to whether its products will complete the lengthy, complex and costly clinical trial and regulatory approval process for new drug approvals required for marketing approval, uncertainty about whether their cell autologous vaccine immunotherapy can be developed to produce safe and effective products and, if If so, if their vaccine products are to be commercially accepted and profitable, the expenses, delays and uncertainties and complications that development-stage biopharmaceutical companies often face, financial and development obligations under license agreements to protect their rights about its products and technologies, obtain and protect new intellectual property rights and avoid infringement of third parties and their dependence on manufacturing by third parties.
The Company does not undertake any obligation to update forward-looking statements of beliefs, opinions, projections or other factors, should they change, except as required by law.
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