Oldest producer in the world of chemo drug Paclitaxel for Injection fights for its life

On April 11, 2014 Health Canada suspended Biolyse Pharma's establishment license, abruptly closing the plant down, throwing 60 people out of work and threatening the supply of a first line chemotherapy drug for breast, lung and ovarian cancers.

ST. CATHARINES, ON, May 12, 2014 /CNW/ - This information is submitted in response to the Health Canada (HC) Press release of May 9th, 2014 in regards the suspension of the Biolyse Pharma (BP) Establishment License. We wish to briefly correct the inaccuracies and suppositions set forth in the HC press release:

(HC) Supply of Paclitaxel will not be disrupted for Canadian patients

(BP) In all of it's history Biolyse has never had a back order or product shortage.

See story concerning Paclitaxel backorder below:

http://abcnews.go.com/Health/CancerPreventionAndTreatment/chemo-drug-taxol-shortage-leaves-doctors-scrambling-cancer/story?id=13906891

On the question of significant concerns on the manufacturing process.

Biolyse Pharma has not brought any changes to its manufacturing process since it was first approved for its clinical batches in 1992 and for its commercial manufacturing in 2001. Biolyse is the oldest manufacturer of Paclitaxel in the world.

The manufacturing process was observed for a full day, in real time during a routine Health Canada inspection last year and approved. The new inspectors were again invited this year to witness the manufacturing procedure which they declined. We can only conclude that they had no concerns on the process at that time. They departed and proceeded to revoke the Establishment Licence a few days later.

Biolyse's manufacturing process is supported by sound scientific evidence which substantiates the safety of the manufacturing method, environmental conditions and testing methods which all reflect the requirements of the Good Manufacturing Guidelines. Supportive data and trend monitoring was available to the inspectors.

(HC) To receive and maintain an establishment license in Canada a company must comply with Good Manufacturing Practices (GMP), which help ensure that the drugs sold in Canada are safe, effective and of high quality. These guidelines are applied to all companies and are widely known.

(BP) Health Canada has not demonstrated the lack of safety, efficacy or quality of the product. Biolyse's specifications are the most stringent in the industry. Numerous examples can be given, be it the physical, chemical or environmental parameters in which we exceed industry standards.

(HC) Health Canada has confirmed that supplies of paclitaxel are available from another manufacturer that is licensed to produce it in Canada. The Department is also in regular contact with the provinces and territories regarding the supply situation. There has been no supply disruption caused by the license suspension.

(BP) It is to our understanding there is no other Canadian manufacturer of Paclitaxel for Injection. Product may be available from unreliable offshore sources or may be available in the future from product made in India.

(HC) In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment. However, Health Canada cannot be assured that future supplies of Paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved.

(BP) Again we repeat that no serious manufacturing deviations were noted during this recent inspection by Health Canada. The observations from the Health Canada inspectors that have led to the above comment totally disregard the empirical scientific data that is available. Thus in this case, the observations are based on interpretation only and can easily lead to a subjective train of thought with misleading conclusions and opinions.

We strongly believe if the inspection procedure would have respected the Food and Drugs Act of Canada, Biolyse would still be supplying its safe and efficacious product to the oncology centres of Canada.

SOURCE: BioNiagara

For further information: Media Contact: John R. Fulton, BioNiagara, Invent@bion.ca, 905.932.7883

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