Easton Pharmaceuticals Announced that the Approval Process for Cancer Drugs Paclitaxel and Docetaxel From Biolyse Pharma Has Been Shortened
Easton Pharmaceuticals Inc. (OTCMKTS:EAPH) announced that Ackerman Pharma has provided a positive update on the regulatory filing towards the Ministry of Health approval for the generic cancer drug “Paclitaxel” and “Docetaxel” from Biolyse Pharma.
As quoted in the press release:
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.
Michael Ackerman, president of Ackerman Pharma, commented:
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.