Health Canada reinstates Biolyse Pharma's Establishment Licence
New team of inspectors assign compliance (C) rating and green light to proceed
St.Catharines, June 12 2015 - The Establishment Licensing Unit of Health Canada announced today that as a result of a recent re-inspection of the Biolyse Pharma facility located in St Catharines, the company's Establishment License has been reinstated following a Compliance Rating (C).
During the inspection, by a new team of Health Canada inspectors, Biolyse demonstrated that the activities it conducts are in compliance with the Food and Drug GMP Regulations. Biolyse has been anxiously awaiting the reinstatement of their (EL) to start operations.
Biolyse produces and supplies Paclitaxel for Injection to 80% of the Canadian market and is the oldest manufacturer in the world of this important chemotherapy medicine. Biolyse's introduction of Paclitaxel to the Canadian market in 2001 has brought the price for Canadian cancer patients down to 1% of the original cost saving the Canadian Health Care system hundreds of millions of dollars and making the drug readily accessible. After months of hurdles the Biolyse team is eagerly looking forward to producing again and to carry on with its drug development projects .
In 2013 Biolyse received a $2.9 million loan from the Fed Dev Ontario Prosperity initiative. This investment has enabled Canada's only producer of oncology drugs to expand its manufacturing capacity and to assist in the development of several new generic injectable chemotherapy drugs. The expansion plan has already created over 50 new jobs and will permit the company to contribute to ease of access to affordable, life-saving anti-cancer treatments.
Biolyse Pharma is a fully integrated sterile fill facility located in Southern Ontario. The company has unique capabilities to fill a diversity of products. The total number of such facilities in Canada can be counted on one hand. Presently Biolyse specializes in the manufacturing of Paclitaxel for the treatment of cancer.
Paclitaxel is best-known for its mild side effects when compared to similar chemotherapy agents and is used on a wide variety of cancers.
Biolyse has been involved in the production of Paclitaxel for Injection for over twenty five years. The company is the oldest producer of paclitaxel in the world. Biolyse supplies approximately 80 percent of the Canadian demand. Since Biolyse has been on the market, it has supplied this medicine for many hundreds of thousands of treatments.
Paclitaxel for Injection has been on the drug shortage list in most western countries with the exception of Canada; Biolyse Pharma has never experienced a back order.
Over the years, Biolyse has proven its commitment to cancer patients by providing this medicine at the fairest price possible.
More specifically to Canada, this pricing structure has resulted in multimillion dollar savings to the health care system. The availability of this reliable supply has tripled the use of Paclitaxel in Canada.
Amongst other significant achievements, Biolyse challenged, in 2001, the practice of ever-greening, a practice in which patents were deliberately extended to limit competition.
The supreme court of Canada sided with Biolyse Pharma and this victory extended to all prescription drugs bringing about savings of billions of dollars to the Canadian public.
The company is presently developing thirty products to assist in alleviating the ever increasing drug shortages that are plaguing the Canadian health care system. Biolyse Pharma has been researching a novel compound that is showing promising results for its use in the fight against cancer.
For further information and media inquiries please contact:
- John R. Fulton
- [email protected]