$EAPH and Partner BMV Medica Announces Regulatory Filing

Over the next few weeks Defi Latina — one of only a few authorized third-party reviewers licensed by the Ministry of Health in Mexico to review and pre-approve Regulatory dossiers prior to submission — is undergoing a detailed review of the regulatory dossier for VS-Sense, a unique point-of-care vaginal discharge diagnostic test called VagiSan 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 expects approval to be granted before the planned launch date of April 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. Easton’s partner, BMV Medica is in the process of having the Marketing Approvals (registrations) transferred to 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.

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 introduction 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 currently 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.

Easton expects to shortly announce and provide positive updates on its 2 generic cancer drug initiatives for the Mexico market for approved drugs Paclitaxel and Docetaxel from Canadian Pharma company Biolyse.

BioLyse Pharma, Generic Cancer Drugs Paclitaxel, Docetaxel

Easton / BMV have acquired licensing and distribution rights from Canadian Drug Manufacturer BioLyse Pharma for generic cancer drugs Docetaxel and Paclitaxel for Mexico and Latin America. Following unforeseen delays regarding the dossier and documentation received, Ackerman Pharma has provided a positive update on the regulatory filing towards the Ministry Of Health approval for the generic cancer drugs “Paclitaxel” and “Docetaxel” from St. Catharines, Ontario based Biolyse Pharma Corporation, where it believes through DEFI Latina, a government authorized third-party reviewer, the approval process is expected to be approved and ready for sale by June 2016. The country of origin for the generic cancer drugs is Canada, believed to be one of the top six in the World — along with the USA, Britain, Australia, France and Germany. Mexican Health Authorities traditionally have very few issues with pharmaceutical products manufactured in these countries and believes a fast track approval is possible with purchase orders and sales to shortly follow. The majority of sales in Mexico will be to the Mexican government hospitals and institutions. As Canada is part of the North American Free Trade Agreement (NAFTA), Canadian-manufactured pharmaceuticals qualify for the national tender program in Mexico, providing a major advantage over other non-NAFTA manufacturers. The “Docetaxel” market in Mexico is by itself worth tens of millions of dollars annually, and BMV expects to be able to garner 20% of that within a year of launch, growing to 30% within three years. The total generic cancer drug market in Mexico represents hundreds of millions of dollars.

Mr. Michael Ackerman, President of Ackerman Pharma stated: “We are aggressively expanding our product and sales channels, and with the addition of these first two generic cancer drugs manufactured by Biolyse Pharma, we are working towards approval in Mexico for later this year with BMV Medica and Easton Pharmaceuticals.”

Amnio-Sense Amniotic Fluid Diagnostic Test Approval

Easton Pharmaceuticals and its partner BMV have the rights to the approved amniotic fluid leak test for rest of Latin America, and are in the process of final packaging for the Latin American market under the EvaPro brand. Sales could begin immediately once commercial alliances have been established in the region. These exclusive licensing rights were jointly purchased by Easton and BMV Medica from Israel-based Common Sense Inc. on a 50/50 profit sharing agreement which encompasses the countries in Central and South America except Brazil. The AL-Sense Amniotic Fluid Diagnostic Leak Test to be called AmnioSense is a patented women’s diagnostic product that is currently being sold in the United Kingdom, and has European Approval. It serves a huge market, and the birth rate in Latin America is three times the birth rate in North America and most of Europe. The target market for BMV/Easton has a population exceeding 200 million people. Sales in Latin America for pharmaceutical and diagnostic products are expected to grow at a rate five times that of North America and Europe as a result of a much higher birthrate in the region and other factors as well.

GynoFit Lactic Acid Gel Treatment For Bacterial Vaginosis (BV) in Mexico

Already approved in Mexico by the Swiss manufacturer who used a regulatory consultant to approve the product, Easton / BMV has an agreement in place including pricing from the manufacturer, and will place its first order within a few more weeks, pending finalization of the transfer of the registration to BMV. This product is expected to become a big selling product as it can treat Bacterial Vaginosis successfully without the use of harsh drugs.

These two approved products can be sold almost immediately in these countries pending final design and packaging. BMV/Easton has commenced discussions for distribution of the products with accredited distribution partners and is in discussions for another approved diagnostic product for Mexico and Latin America.

Dr. Jose Tiran Saucedo

Easton Pharmaceuticals previously announced the appointment of Dr. Jose Tiran Saucedo as the Founding Member of Easton Pharma’s Medical/ Scientific Advisory Board. In this capacity Dr. Tiran is advising Easton Pharmaceuticals/BMV Medica and other regional partners in planning the Latin American launches of its suite of patented, exclusive women’s health products over the coming months.

Dr. Tiran stated, “I am very excited to be part of the program for these soon-to-be-launched women’s health and treatment products in the hope of providing to Latin American women the same choices they have in the US and Europe. We have a huge unmet medical need in Latin America for these kind of alternative diagnostic and treatment products. The vaginal discharge diagnostic test will facilitate a woman’s ability to determine the causative agent; the natural lactic acid treatment gel will provide a new, non-toxic treatment option, and put Latin American women on a par with North American and European women. The professional version of this diagnostic test will also enable the gynecologist to increase the accuracy in the differential diagnosis of vaginal discharge, right in the gynecologist’s office, something currently lacking in Latin America. The natural lactic acid gel treatment expected to launch in parallel with the diagnostic will be offered to women who test positive for bacterial infection and is a significant treatment option advance since it could obviate the need for potential use of antibiotics and further presence of bacterial resistance, so this is a promising and exciting development for the future of women’s health.”

Dr. Tiran further commented, “The amniotic fluid leak test will allow late-pregnancy women to have at their disposal a high-specificity/accuracy test at a fractional cost to other options on the market, with a very favorable ease-of-use component, thus contributing to an increase in the quality of perinatal care in Latin America. All these are new advances coming to Latin America, which I believe will catch on very quickly in both the community and the professional arenas.”

Dr. Jose Tiran is a Thought Leader (KOL- Key Opinion Leader) in Gynecological Infectious Diseases, and is a Fellow of the American College of Obstetricians and Gynecologists. He has been a strong advocate over the years in women´s health worldwide. Also, Dr. Tiran has published numerous peer-reviewed papers on the subject, and is also board certified in Mexico, a member of multiple health societies, and holds numerous other prestigious positions in the field of Women’s Health. Dr. Tiran is also well versed in other aspects of women’s health such as sexually transmitted diseases, female sexual health, contraception, vaccines and gynecology and women´s health and wellbeing.

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 entered into a 50 / 50 revenue sharing agreement towards being the exclusive distributor 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 and hold an exclusive option to purchase up to 49% in a (MMPR) medical marijuana grow-op business post granting of license from Health Canada in Ontario, which has received a letter to build from Health Canada. 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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