TORONTO, ON--(Marketwired - Sep 26, 2016) - Easton Pharmaceuticals Inc. (OTC PINK: EAPH) announces COFEPRIS (Mexican Ministry of Health) has granted Marketing Authorization for VagiSan (also known as VS-Sense) diagnostic test, supporting on-going exclusive partnership negotiations for Mexico and other Latin American markets with several multinational pharmaceutical companies.
The filing, review and approval process has taken over a year which is longer than originally anticipated, but a remarkably short period of time given the average time to approval is between two and three years for most Health Sector products in Mexico. The approval is in Ackerman Pharma's name, fulfilling the legal requirement that the Marketing Authorization holder have an Establishment License. This is common practice in Mexico where the "host" holds the approval in the name of the sponsor company.
This approval will support and is expected to add value to on-going formal negotiations with several multi-national pharmaceutical companies, initiated in late 2015 and early 2016. These multi-national pharmaceutical companies are world-wide leaders in providing innovative products in Women's Health and are striving to grow the Latin American segment of their operations by adding VagiSan to their product offerings. The formidable Sales & Marketing strengths of these multinational companies bodes well for the sales potential for VagiSan and the other Women's Health products, AmnioSense and Gynofit, which are also in active discussions with these potential partners.
Easton and BMV each expect negotiations to be finalized over the next quarter, with all three products now registered in Mexico, and sales expected to begin QI 2017, for one or more products consisting of Gynofit, AmnioSense and VagiSan. Once launched, these products are expected to reach several million dollars in sales within two years of launch.
VagiSan is the current brand name of the BV (Bacterial Vaginosis) diagnostic test, planned for launch in Mexico and Latin America, but may be renamed depending on the outcome of partner discussions and is the same product Bayer Consumer Health had licensed and launched in late 2015 in Europe under its brand, Canestest. Prestige Distribution is currently selling in the US under its brand, Monistat, with multi-million dollars in sales. Although, Easton is unable to disclose any names of partnership discussion companies, it can confirm that the companies are all considered large multi-national pharmaceutical companies with a broad international distribution network.
The AmnioSense amniotic fluid leak test, as well as the Gynofit bacterial vaginosis treatment, is already approved in Mexico through third-party consultants, so all three products could be launched at the same time. An initial order for Gynofit is expected once the final agreement has been executed.
About Easton Pharmaceuticals
Easton Pharmaceuticals is a diversified specialty pharmaceutical company involved in various pharmaceutical sectors and other growing industries. The Company previously developed and owned an FDA approved wound-healing drug and currently owns topically delivered drugs to treat cancer and other therapeutic products to treat various conditions that are all in various stages of development and approval. Easton has partnered with BMV Medica and owns 50% of the exclusive distribution in Mexico and Latin America for patented women's diagnostic products and two generic cancer products. Easton has made additional investments into AMFIL Technologies, a company who own rights to a product called the groZONE anti-microbial airflow system for the medical marijuana and other industries. The company's gel formulation is thought to be an innovative and unique transdermal delivery system that can in the future be adaptable in the delivery of other drugs and Cannabidiol extracts.
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