$EAPH Has Moved Toward Signing Sales & Distribution Agreement

Easton and its partner BMV Medica S.A de C.V have been in formal discussions over the last several months with a Europe-based Multi-National Pharma company who currently has a successful foothold within 38 countries, including Mexico, with specialized Women’s Health products. The negotiations have progressed well with interest being high, which has now resulted with both companies moving toward signing a final agreement whereby this company would use its large marketing and distribution resources to take over and spearhead all marketing and distribution of Easton/BMV’s VS-Sense, AmnioSense and Gynofit products beginning with Mexico. A final agreement would most likely be executed with the products being launched in stages starting with Gynofit as its first product launch. The regulatory approvals for the VS-Sense and AL-Sense products from the Mexican Ministry of Health is imminent with Gynofit already approved for sale. Although Easton is not at liberty at this time to disclose terms or names, the European multi-national company currently has sales in the Billions of Dollars throughout 38 countries. A partnership with such a company would provide Easton Pharmaceuticals with a significant increase in projected sales than if Easton was to proceed alone. Current projections from the European based company have sales for Gynofit alone at $7,000,000 within 12 months of product launch.

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. 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 Pharmaceuticals 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 third quarter, 2016.

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. The European multi-national pharma company anticipates placing an initial order for Gynofit once the final agreement has been executed.

Easton/BMV anticipate the bulk of its sales initially from the Obstetrician/Gynecologist community in Mexico and have already received their 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 Amnio-Sense diagnostic product currently approved for sale in Mexico is owned exclusively for Mexican sales by Easton’s partner BMV Medica, but Easton owns together with BMV the rest of Latin America sales, and Easton is in high level discussions with BMV to include AmnioSense for Mexico in the agreement currently in place.