Easton Pharmaceuticals and BMV Medica Close on Joint Distribution Agreement for Injectable Approved Cancer Drugs for Mexico and Other Latin American Countries With Biolyse Pharma Corporation

Posted by on Jun 15, 2015 in News | 0 comments

TORONTO, ON–(Marketwired – Jun 15, 2015) – Easton Pharmaceuticals Inc. (OTC PINK: EAPH) announces it has closed on the recently announced MOU with BMV Medica S.A. de C.V. to distribute injectable approved cancer drugs from Biolyse Pharma for Mexico and Latin America.

The Easton / BMV agreement is under similar terms as previously announced with the Common Sense Inc. agreement for the diagnostic women’s health products which maintains a 50/50 net profit sharing on all sales of a line of generic cancer drugs beginning with “Paclitaxel” and “Docetaxel” from St. Catharines, Ontario based Biolyse Pharma Corporation. The terms of the agreement calls for Easton to support the regulatory filings in Mexico for marketing authorization (MA) together with some ancillary costs.

The regulatory filing process has commenced and Easton has forwarded funds directly to Ackerman Pharma who is overseeing the submission and has received the necessary documents from Biolyse Pharma. Once the completed and translated submission package is ready, it will be put in “fast-track” status through a government-approved, third-party authorized reviewer, and if no further documentation is required, the approval could be granted in a few short months. Biolyse’s “Paclitaxel” is already approved in Canada and several other countries worldwide, and “Docetaxel” has been filed for approval with Health Canada.

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 approximately US$15 MM annually, and BMV expects to be able to garner 20% of that within a year of launch, expected in late 2015 or early 2016, growing to 30% within three years. The total generic cancer drug market in Mexico represents hundreds of millions of dollars.

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 $30,000 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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