Easton Pharmaceuticals Announces Receipt Of All Technical Documents From Biolyse Pharma For Filing Of A Marketing Authorization Dossier Towards Fast Track Approval With The Mexican Ministry Of Health For Cancer Drug Paclitaxel
Published: Nov 16, 2016
TORONTO, ON--(Marketwired - November 15, 2016) - Easton Pharmaceuticals Inc. (OTC PINK: EAPH) announces that all required technical documents have been received from Biolyse Pharma Corporation of St. Catharines, Ontario, Canada, for cancer drug Paclitaxel and are now ready for submission for fast track approval with the Mexican Ministry Of Health.
Easton Pharmaceuticals and partner BMV Medica have secured the rights from Biolyse Pharma to distribute the generic cancer drugs Docetaxel and Paclitaxel for Mexico and Latin America. The regulatory landscape and requirements have recently changed regarding the validation and sourcing of raw materials or Active Pharmaceutical Ingredients (API) received for incorporation into the final manufacturing process from overseas suppliers, which has caused delays in the filing process. Easton / BMV through Ackerman Pharma in Mexico will file a conditional submission for approval, enabling Biolyse time to receive the final Good Manufacturing Practices (GMP) approval for its raw material, expected within 3 to 6 months, paralleling the expected timeline for Mexican government approval. Easton / BMV / Ackerman are negotiating and expect a Purchase Order immediately upon receipt of Mexican Marketing authorization.
Now that the dossier is near completion, only awaiting the Biolyse GMP certificate and Certificate of Pharmaceutical Product (CPP), documents which need consularization, which is a two-to-three week process, Ackerman Pharma has provided a positive update on the regulatory filing with the Mexican Ministry Of Health for approval of the generic cancer drug Paclitaxel from St. Catharines, Ontario-based Biolyse Pharma Corporation. DEFI Latina, a government authorized third-party reviewer, will then be filing for a "fast-track" approval, considerably shortening the approval time from several years to 3 to 6 months, similar to the previously announced VagiSan (VS-Sense) approval.
The majority of expected sales in Mexico will be to the Mexican government hospitals and institutions. Canadian-manufactured pharmaceuticals qualify for the national tender program in Mexico, providing a major advantage over other non-NAFTA manufacturers. The paclitaxel and docetaxel market in Mexico is by itself worth tens of millions of dollars annually. Easton / BMV expect to be able to garner 20% of this market 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.
Ackerman Pharma is a niche pharmaceutical company operating in Mexico, holder of an Establishment License in Mexico, and also active in Sales & Marketing of Diagnostic Devices and Hospital-based injectable drugs. Ackerman currently holds five product 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 where 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 which Easton has initiated and are currently in discussions with. 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 forecast annual supply.
Biolyse Pharma markets "Paclitaxel" in Canada and other countries around the world and currently has an overwhelming majority of the Canadian market. Biolyse has been a factor in substantially bringing down the price 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 for BMV/Easton.
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 several times the rate 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.
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 Latin America, geared towards its several hundred million female population where 1 in 3 women will at some point require the use of the test, and currently being sold in the US in CVS and Walgreen's drug stores in the US, and Shoppers Drug Mart stores in Canada, and by Bayer in Europe.
Medical Marijuana News Updates
Easton Pharmaceuticals has initiated discussions with 2 medical marijuana companies in Canada who currently hold letters to build and are in the late stages under the new ACMPR system which has replaced the older MMPR system. Easton has prepared and is ready to forward a formal acquisition proposal to one and possibly both of these companies as a result of the anticipated legalization of medical marijuana in Canada sometime in the spring of 2017. No names can be disclosed until licensing has been granted, however a much more comprehensive update is pending approval.
In other news, as previously announced, Easton continues to confirm it has received and is extensively reviewing a preliminary proposal from a major multi-national pharmaceutical company for its regulatory approved, patented VagiSan (known as VS-Sense) woman's diagnostic test Bacterial Vaginosis for the countries Mexico and Ecuador. In addition, Easton Pharmaceuticals continues to confirm it has entered the contract phase with a second large Pharmaceutical company towards distribution of other Easton licensed products and territories.
About Biolyse Pharma
Biolyse Pharma Currently maintains a 130,000 sq. ft. facility Licensed aseptic GMP facility, as well as GLP analytical laboratories, Research and Development Facilities, Large scale extraction, purification facility, and possesses Multidisciplinary teams of various scientific expertise. Biolyse Pharma Corp. is a research driven, fully integrated pharmaceutical company headquartered in St. Catherine, Ontario, Canada dedicated to the manufacturing, marketing, and distribution of anti-cancer drugs.
For More Information Visit: http://www.biolyse.com
About Easton Pharmaceuticals
Easton Pharmaceuticals is a diversified specialty pharmaceutical company involved in various pharmaceutical sectors and other growing industries. The Company previously developed and owned an FDA-approved wound-healing medical device and currently owns topically delivered drugs to treat cancer and other therapeutic products to treat various conditions that are all in various stages of development and approval. Easton has partnered with BMV Medica and together own the exclusive distribution rights in Mexico and Latin America for patented women's diagnostic products and two generic cancer drugs. Easton has made additional investments in the medical marijuana industry through AMFIL Technologies, a company involved in medical marijuana and other industries as well as advancing funds towards another Canadian medical marijuana initiative who has received a letter to build under the MMPR system in 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 other drugs and Cannabidiol extracts.
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