TORONTO, ON–(Mar 22, 2017) – Easton Pharmaceuticals, Inc. (OTC PINK: EAPH) announces it has forwarded together with BMV Medica a $300,000 payment to CommonSense of Israel clearing the way for the closing of an anticipated exclusive sub-distribution agreement with a major, multi-national, pharmaceutical company for the women’s diagnostic product AL-Sense (AmnioSense). In addition, Easton / BMV through their commercial alliance partner Ackerman Pharma, provides update on the regulatory filing of Generic Cancer Drug Paclitaxell, currently licensed together with Docetaxel through Biolyse Pharma of St. Catherines Ontario, through “fast-track” third-party authorized reviewer DefiLatina Healthcare, S.A. de C.V. towards regulatory approval in Mexico and other parts of Latin America.
Easton Pharmaceuticals / BMV Medica, last week advanced a $300,000 payment to CommonSense of Israel as an additional payment to secure the rights to women’s diagnostic products AL-Sense and VS-Sense, with the majority of the payment advanced by Easton Pharmaceuticals. The payment was advanced after a detailed marketing plan was submitted to CommonSense by Easton / BMV and its soon to be sub-distribution partner, which competed with another large company who was attempting to also acquire the rights to AL-Sense. The payment by Easton / BMV was the last hurdle, prior to a sub-distribution agreement being executed with a multi-national pharmaceutical company for AL-Sense who have sales in the billions of dollars. Easton is now exchanging and reviewing documents and final agreements towards the execution of the sub-distribution agreement which would result in the launch of its second product (AmnioSense), starting in Mexico and Central America.
In other developments, Easton and BMV have received a positive update and are anticipating the delivery of a final document which would resolve prior unforeseen delays in the regulatory filing of the generic Cancer Drug Paclitaxel, currently licensed from BioLyse Pharma of St. Catherines, Ontario, Canada. Easton / BMV have received the final test results from BioLyse Pharma. In addition to the test results document, a further required verification that the raw material (API) sourced from China has the appropriate GMP certification which Mexico now requires. Once received, those documents will then be consularized at the Mexican Consulate which would then clear the way for the fast track filing to be submitted by 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. As was the case with women’s diagnostic product, VS-Sense. The “fast-track” review process through authorized third-party reviewers can speed up approval times from several years to a few short months. VS-Sense was approved within 2 months of its regulatory filing, although drugs products require typically six months in the fast-track process.
Easton / BMV acquired licensing and distribution rights from Canadian Drug Manufacturer BioLyse Pharma for generic cancer drugs Docetaxel and Paclitaxel for Mexico and Latin America. The country of origin for the generic cancer drugs is Canada, believed to be one of the top six regulated countries 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 total generic cancer drug market in Mexico represents hundreds of millions of dollars.
Amnio-Sense Amniotic Fluid Diagnostic Test
The AL-Sense Amniotic Fluid Diagnostic Leak Test (AmnioSense) is a patented women’s diagnostic product that is currently being launched in the United Kingdom, and has European Approval. It serves a huge market, as the birth rate in Latin America is three times the birth rate in North America and most of Europe. The target market for Easton / BMV 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.
Dr. Jose Tiran Saucedo
Easton Pharmaceuticals / BMV previously announced the appointment of Dr. Jose Tiran Saucedo as the Founding Member of Easton Pharma’s Medical/ Scientific Advisory Board. It was Dr. Tiran, who assisted in resolving issues that led to the $300,000 payment to CommonSense. 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.
Other Initiatives / Negotiation Updates
Although there have been obvious delays with the anticipated closing of its acquisition of iBliss, a successful vaporizer and e-liquids manufacturer, Easton is attempting to resolve various issues and disagreements that have materialized. After a brief lull, negotiations were restarted this week with face to face meetings planned with the anticipation and belief of a closed agreement eventually being reached. In addition to iBliss, Easton is also involved in late stage discussions with a medical marijuana company based in Jamaica and has entered into discussions with AMFIL Technologies. Easton is diligently working towards reaching terms acceptable to all parties on one or all initiatives
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 SA de C.V. and together, own the exclusive distribution rights in Mexico and Latin America for patented women’s diagnostic and preventative care products from CommonSense Of Israel, along with two generic cancer drugs, Paclitaxel and Docetaxel from BioLyse Pharma of St. Catherine’s Ontario, Canada.
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