Bioniche closer to E. coli cattle vaccine approval

Wed Sep 24, 2008 1:59pm EDT

 

Source of Article:  http://www.reuters.com/article/marketsNews/idUSN2430780420080924

 

TORONTO, Sept 24 (Reuters) - Bioniche Life Sciences (BNC.TO: Quote, Profile, Research, Stock Buzz) moved closer to receiving a marketing license for its E. coli cattle vaccine on Wednesday after Canada's health watchdog said the treatment met some of the key requirements.

The biotechnology company, which specializes in animal and human health treatments, said the Canadian Food Inspection Agency ruled that recently submitted data provided "definitive evidence that the vaccine meets the efficacy and safety requirements for full licensing of the vaccine."

The data, taken from a study conducted by the University of Saskatchewan, showed a significant reduction in the amount of bacteria shed by vaccinated animals and the number of animals shedding.

The agency said the supplemental data, along with previous data, supported its decision to grant it a license.

However, the company must first complete quality control tests on three pre-commercial batches in order to demonstrate its manufacturing processes. Bioniche expects to meet these requirements within the next few months.

"This news is extremely encouraging," Graeme McRae, chairman, president and chief executive, said in a release.

"We have demonstrated definitive efficacy of the vaccine and, on completing one last task, we'll have a full license in hand."

The company is also working with the United States Department of Agriculture for a similar ruling. The agency ruled in February that the vaccine met the efficacy standard was eligible for a conditional license.

However, the agency requested additional data before a full license is issued.

The conditional license will provide Bioniche with full access to the U.S. market but requires that at least one step in the manufacturing process be performed in the United States. Also Bioniche will not be permitted to use a trademark name for the vaccine. ($1=$1.03 Canadian) (Reporting by Scott Anderson; Editing by Frank McGurty)

 

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