TORONTO, ON–(Marketwired – Jul 6, 2015) – Easton Pharmaceuticals Inc. (OTC PINK: EAPH) announces positive update from Ackerman Pharma; where the regulatory filing and anticipated approval process for the cancer drugs Paclitaxel and Docetaxel has been shortened.
As previously announced, Easton Pharmaceuticals / BMV Medica have secured the rights from Biolyse Pharma to distribute the generic cancer drugs Docetaxel and Paclitaxel for Mexico and Latin America.
Due to the quick and detailed dossier and documentation received from Biolyse Pharma, 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 will be greatly reduced and is expected to be approved and ready for sale by the end of calendar 2015, barring any unforeseen comments.
This is partly due to the fact 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.”
Ackerman Pharma is a niche pharmaceutical company operating in Mexico, in the Health Sector Regulatory Affairs and Sales & Marketing of Diagnostic Devices and Hospital-based injectable drugs. Ackerman currently holds five products with Marketing Authorizations in Mexico.
In other Latin American countries, BMV/Easton expect to sell in aggregate an equal amount of Biolyse’s cancer drugs as in Mexico, and some of these other countries have a more streamlined regulatory approval process, allowing BMV to begin selling almost immediately pending distribution arrangements with local companies. In these other Latin American markets, the buying of cancer drugs mimics the Mexican model, in that government agencies allow for tender bids to meet their forecasted annual supply.
Biolyse Pharma is currently selling “Paclitaxel” in Canada and other countries around the world and currently has an overwhelming majority of the Canadian market. Biolyse has been credited with substantially bringing down the costs for “Paclitaxel” in Canada from around $5,000/vial to less than a $100/vial a few years ago. Both “Paclitaxel” and “Docetaxel” are generic drugs and are amongst the most commonly prescribed for several of the most common cancers including breast, lung and ovarian cancers. In addition, “Docetaxel” is extremely difficult to manufacture with only a limited number of companies worldwide possessing the knowhow and facilities to manufacture these and other cancer drugs. As previously stated, the securing of the distribution agreement by BMV for these drugs is another major achievement and BMV/Easton have now secured a full line of diagnostic, cancer and other drugs.
The Cancer drugs distribution agreement and investment by Easton in BMV builds on the previously announced agreement with Easton and BMV securing the exclusive rights to market and sell CommonSense Ltd’s VS-Sense women’s diagnostic products for Mexico, geared towards its 70 million female population where 1 in 3 women will at some point require the use of the test. Easton / BMV will shortly announce its trademarked white labeled name for the products similar to what are currently being sold in CVS, Walgreen’s drug stores in the US, and Shoppers Drug Mart stores in Canada.
A 20% share of the Mexican and other Latin American markets could represent tens of millions of dollars in revenues, as overall pharmaceutical sales in Latin America are growing at five times the rate as compared to Canada and the US (12-15 % vs 2-3%). The cancer drugs industry is considered a high value business segment to be part of as cancer drugs are expected to surpass cardiovascular drugs as the biggest selling drugs in the world. Every major government body around the world has indicated that cancer will continue to impact more and more people and lives around the world especially in countries possessing an aging population. In addition, Easton remains committed to its own early stage cancer drug “Xilive,” which it purchased rights for in late 2013. The Company anticipates working out a deal with the majority owner of “Xilive” where Easton will acquire majority control in exchange for a percentage of future royalties and shares of Easton’s common stock.
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