Easton Pharmaceuticals Announces Formal Agreement & Advances Payment to BMV Medica S.A. Towards a Regulatory Filing in Mexico for “Viorra”; Company Anticipates Approval and Initial Sales by End of Second Quarter 2014

Posted by on Oct 22, 2013 in News | 0 comments

TORONTO, ON–(Marketwired – Oct 22, 2013) – Easton Pharmaceuticals, Inc. (OTC: EAPH), a specialty pharmaceutical company that designs, develops, and markets a premium array of topically-delivered drugs and therapeutic healthcare products announced today it has signed a formal agreement with BMV Medica S.A. de C.V. (BMV) a Mexican Regulatory & Licensing consultancy to begin the process of submitting applications to obtain regulatory government approvals for its flagship product “VIORRA.”

The agreement calls for milestone payments to be made to BMV and has confirmed that an initial up- front payment representing 33% (“percent”) of the total owed, plus a consultant fee, has been advanced to BMV towards the “VIORRA” government regulatory filing, which represents the first such payment to BMV after previous delays. The remaining payments as per the agreement, calls for milestone payments to be made over the next 6 month period which includes the drafting and submission of a comprehensive Dossier. BMV has guaranteed to the Company, pending the receipt of appropriate manufacturing documents, the company shall receive not only regulatory approval in Mexico, but shall search and deliver on a suitable distribution partner for sales and marketing. “Viorra” is an over-the-counter aid meant to restore and improve vaginal moisture and elasticity which has a very positive effect on women’s sexual desire and arousal targeted for women suffering from FSAD (Female Sexual Arousal Disorder). VIORRA is a topical, daily-use product formulated with ingredients classified by the FDA as Generally Recognized as Safe.

Carla Pepe, Easton Pharmaceuticals Marketing Director / Corporate Secretary and Director, stated, “We are pleased to have moved forward with BMV and to have them see this through on all fronts on behalf of Easton Pharmaceuticals, in Mexico and other Latin American markets.” Miss Pepe further commented, “Our analysis suggests Mexico represents an ideal territory launch site for our VIORRA Female Sexual Dysfunction (FSAD) product in our Latin American market initiatives. Male Sexual Dysfunction products have historically done very well in Mexico, and with a population near 120 million, the company foresees a significant opportunity with excellent potential for success for a safe product with no risky drug induced side effects. We anticipate the product being well received by the general public in Mexico. The world market for products designed to treat females possessing these types of conditions are in the Billions of Dollars.”

BMV estimates the regulatory process to require six to seven months until a marketing approval is obtained and in parallel with the regulatory filing. BMV will immediately begin talks with several targeted distribution companies focused on sales and marketing in the women’s health, sexual arousal disorder and the sexual wellness market. Easton Pharmaceuticals believes that with both the regulatory and commercial alliance initiatives running in parallel, this will enable a timely, successful launch of VIORRA in Mexico sometime in the first half of 2014 now that payments have been forwarded to BMV.

Ms. Mendoza Vazquez of BMV stated: “We are very excited to be working with Easton Pharmaceuticals and hope to fast-track this approval. The Latin American culture is one in which we believe this product will be very well received and could perform extremely well in.”

About BMV Medica, S.A. de C.V.: BMV was founded in 2009, by a group of pharmaceutical professionals, whose background includes regulatory approvals in Mexico for several classes of Health Sector Products, including Medical Devices, Medicines, and a combination of Drug/Device products, as well as nutraceuticals, and cosmetic products. In addition, BMV works with North American and European pharmaceutical companies to assist them with local regulatory approvals and distribution agreements. Ms. Mendoza Vazquez, President of BMV, has previously worked in Marketing, Regulatory and Sales for Schering Plough Mexico, and other Pharmaceutical companies.

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