TORONTO, ON--(Marketwired - Apr 6, 2016) - Easton Pharmaceuticals Inc. (OTC PINK: EAPH), together with their commercial alliance partner BMV Medica SA de CV, provides Mexican Regulatory Filing Update for its Patented Women's Health Diagnostic Product, VS-Sense For The Mexican Market. In addition, Easton / BMV announces it has initiated partnership negotiations for Mexican Sales & Marketing of its suite of women's health products with a multi-national Europe-based pharma company operating in over 38 countries world-wide.
As previously announced in February, Easton / BMV were notified through Ackerman Pharma, the filing of its patented, point-of-care, VS-Sense Diagnostic test through "fast-track" third-party authorized reviewer Defi Latina Healthcare, S.A. de C.V. for regulatory approval in Mexico. As of today, final, corrected documents are expected from the Israeli manufacturer to complete the filing, and are expected within a week.
Since submission, Defi Latina -- one of only few authorized third-party reviewers licensed by the Ministry of Health in Mexico to review and pre-approve Regulatory dossiers prior to submission -- has and continues to undergo a detailed review of the regulatory dossier for VS-Sense, a unique point-of-care vaginal discharge diagnostic test called VagiSan in Mexico. VagiSan is the brand Easton/BMV plan to launch in Mexico and Latin America, and is the same product Bayer had licensed and launched recently in Europe under its brand Canestest, and Prestige Distribution in the US has launched under its brand Monistat, with multi-million dollars in sales.
In Mexico, the "fast-track" review process through authorized third-party reviewers can speed up approval times from several years to a few short months if the regulatory dossier is complete. Easton / BMV have worked diligently over recent months with the manufacturer CommonSense LTD of Israel, to ensure a complete dossier is in place, and expect an approval to be granted before the planned launch date of July/August 2016. The approval has not yet been granted due to unexpected delays with the ministry as is common in many parts of the world regarding drug and diagnostic products. Easton / BMV expect an imminent approval.
Easton / BMV have been in discussions over the last several months with a Europe-based Multi-National Pharma company who currently has a successful foothold in the Mexican market with specialized Women's Health products. The negotiations relate to a possible partnership where this company would take over and spearhead all marketing and distribution of Easton / BMV's VS-Sense, AmnioSense and Gynofit beginning with Mexico. The last phase of negotiations is dependent on the approvals for these three products from the Mexican Ministry Of Health, which Easton believes is imminent.
Prior to the VS Sense Diagnostic test regulatory filing submission, Easton / BMV Medica announced a first-order of the CommonSense products with the total number of units ordered at 230,000, - 90,000 of the VS-Sense and 140,000 of the AmnioSense, enough product for launch and three-six months of sales. The AmnioSense diagnostic test as well as the Gynofit bacterial vaginosis treatment are already approved in Mexico through third-party consultants, and these Marketing Authorizations (MAs) are being transferred to Easton/BMV so all three products can be launched at the same time. Easton / BMV will be placing an initial order for Gynofit with the Swiss manufacturer over the next few weeks, pending completion of the transfer of the MAs.
Easton / BMV anticipate the bulk of its sales initially from the Obstetrician/Gynecologist community in Mexico and have already received its first orders following the presentation of these new products this past November at the OB/GYN conference in Acapulco, attended by approximately 4,000 of the 7,000 gynecologists in Mexico.
The AmnioSense diagnostic product currently approved for sale in Mexico is owned exclusively by Easton/'s partner BMV Medica, but Easton is in high level discussions with BMV to include AmnioSense for Mexico in the agreement currently in place, since AmnioSense is already part of the agreement for the rest of Latin America.
About Easton Pharmaceuticals
Easton Pharmaceuticals is a diversified specialty pharmaceutical company involved in various pharmaceutical sectors and other growing industries such as medical marijuana. 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 also 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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