The Easton and BMV joint partnership has formally engaged Ackerman Pharma, a Mexican pharmaceutical company, to submit applications to obtain regulatory approvals for its exclusive, patented diagnostic product for women's health.
Mr. Michael Padvaiskas, President of Ackerman Pharma said: “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 approve. 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."
Easton and 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.
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.
One in three women will be affected by BV at some point in their lifetime, demonstrating 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.
"Our market analysis reveals that Mexico represents an ideal territory launch site for the VS-Sense diagnostic product line," stated Carla Pepe, CEO and Director of Easton Pharmaceuticals. "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 gynaecologists 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 gynaecologists 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 and Easton Pharmaceuticals has begun its marketing initiatives focused on sales and marketing within Mexico to Gynaecologists 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 by late 2015 to early 2016.
Defilatina Healthcare, S.A. de C.V., and its principals have been in the market for over 11 years. They 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.
Mr. Michael Padvaiskas added: "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."