Easton Pharmaceuticals / BMV Announce Engaging Ackerman Pharma S.A. de C.V. Towards Mexican Government Regulatory Approval Filing on the Company’s New White-Labeled, Patented, Women’s Diagnostic Product From Common Sense Inc.
Common Sense Has Begun Document Flow to Easton / BMV Towards the Filing of a “Fast-Track” Approval, for a Patented, Point-of-Care Diagnostic Test to Determine Causes of Vaginal Infection (Vaginitis), a Condition for Which 1 in 3 Women Will Suffer From, Many of Them Repeatedly
“This patented diagnostic device is a Class II medical device in Mexico, and once all documents are delivered to us, we expect the regulatory filing will require six to eight months to approval. Since the diagnostic device is already approved in Europe, US and Canada, and Common Sense has ISO-13485 designation, we expect the process to run a smooth course,” stated Mr. Michael Padvaiskas, President of Ackerman Pharma. “Due to the backlog of regulatory filings currently in COFEPRIS (Mexican Regulatory Authority), we will retain the services of DEFILATINA Healthcare, S.A. de C.V., a third-party authorized reviewer of regulatory files, headed by Dra. Consuelo Albarran and sanctioned by the Mexican Ministry of Health for “fast-track review”, and if all is in order, expect the approval to be completed this year.”
Easton / BMV have advanced funds towards the government regulatory filing of the Common Sense diagnostic device (trademark name TBA) which was acquired from Israel-based Common Sense Inc., under an exclusive distribution rights agreement for Mexico including their patented product line known as VS-SENSE-OTC and VS-SENSE PRO, for the detection of Bacterial Vaginosis (BV) and Trichomonas. BV is a common condition in which the natural balance of bacteria inside the vagina becomes disrupted. One in three women will get BV at some point in their lifetime, which demonstrates the substantial market and revenue capabilities for the products. The products are currently protected by international patents with approximately 12 years remaining on the patent life and have CE Certification for selling and marketing in the EU obtained under the European Medical Device Directive 98/79/EC, Number IVD000256. The products are currently being sold within the United States and Canada. Common Sense Ltd., through partnerships with industry leaders, will shortly begin selling the VS-SENSE-OTC in several European markets. The products are currently being marketed and sold in the United States through Prestige Brands in CVS, Walgreens and Rite-Aid Drug Stores under their own private label as well as under the leading Women’s Health Care brands and throughout Canada in Shoppers Drug-Mart and Jean Coutu.
- “Our market analysis reveals that Mexico represents an ideal territory launch site for the VS-Sense diagnostic product line,” stated Carla Pepe, Easton Pharmaceuticals’ CEO and Director. “No such product currently exists in Mexico and its estimated 70 Million female target population, a result of the demographics of Mexico where the “demographic bulge” is in the 15-49 yr. old group. We have also learned that while gynecologists in North America almost always have a secondary way to confirm diagnosis of vaginal infections, such as in-office microscopes, in Mexico 99.6% of gynecologists lack this secondary tool to confirm diagnosis, so we expect the Pro version to do extremely well in the professional setting, providing a faster, more accurate diagnosis.” Easton expects the Mexican market to be a precursor to other markets and other extremely lucrative revenue generating initiatives, currently being negotiated and soon to be disclosed.
- Ackerman Pharma, S.A. de C.V. estimates the regulatory process to require no more than six to eight months until a marketing approval is obtained. In parallel with the regulatory filing, BMV/Easton Pharmaceuticals has begun its marketing initiatives focused on sales and marketing within Mexico to Gynecologists who are expected to be involved with the selling and distribution of the product as well as the major pharmacy chains for OTC sales. Easton Pharmaceuticals believes that with both the regulatory and commercial alliance initiatives running in parallel this will enable a timely, successful launch of the diagnostic device in Mexico in the by late 2015/early 2016.
DEFILATINA Healthcare, S.A. de C.V., and its principals have been in the market for over 11 years, and have or currently represent over 37 pharmaceutical companies, some of them in the top 10 multinational pharmaceutical companies in the world, and have over 300 drug/medical device dossiers either approved or in process.
About Common Sense Inc.
Common Sense Inc. is an internationally recognized company holding international patents for their VS-SENSE-OTC (consumer test) and VS-SENSE PRO (professional test) diagnostic products, for the detection of bacterial Vaginosis and Trichomoniasis, conditions that effect many millions of women around the world. The products have FDA and Health Canada approvals, and CE Certification for selling and marketing in the EU obtained under the European Medical Device Directive 98/79/EC, Number IVD000256.
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 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 for world-patented women’s diagnostic products. Easton has completed an acquisition that grants 40% ownership interest in Medicated Markets International LLC; a company holding Medical Marijuana growing rights in California on 20 acres (3 acre growing area). Easton has also made additional investments into AMFIL Technologies, their 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 Cannabidiol extracts.
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Safe Harbor
This news release may contain forward-looking statements or expressions within the meaning of the Private Securities Litigation Reform Act of 1995 (The “Act”). In particular, when certain words or phrases such as “hope,” “positive,” “anticipate,” “pleased,” “plan,” “confident that,” “believe,” “expect,” “possible” or “intent to” and similar conditional expressions are expressed, they are intended to identify forward-looking statements within the meaning of the Act and are subject to the safe harbor created by the Act. Such statements are subject to certain risks and uncertainties and actual results could differ materially from those expressed in any of the forward-looking statements. Any investment made into Easton Pharmaceuticals would be classified as speculative and may contain risks. Such risks and uncertainties include, but are not limited to, market conditions, general acceptance of the company’s products and technologies, competitive factors, the ability to successfully complete additional or adequate financing, government approvals or changes to proposed laws and other risks and uncertainties further stated in the company’s financial reports and filings.
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