A World First: Health Canada Approves Bio-K+® as a New and Effective Mean for the Reduction of Clostridium difficile Infections in Hospitals


MONTREAL, Jan. 16, 2013 /CNW Telbec/ - Today, Bio-K Plus International Inc., a leading Canadian biotechnology company, announced that Health Canada has approved its exclusive and patented Bio-K+® probiotic formula to help reduce the risk of Clostridium difficile (C. difficile) infections in hospitalized patients and those in long-term care facilities. Based on solid clinical evidence published in prestigious medical journals, including the American Journal of Gastroenterology, this approval is confirmation that Bio-K+® is a proven safe and effective product. Despite all preventive measures used, C. difficile still remains a high cause of hospital acquired infections (HAIs) responsible for over 1,000 Canadian deaths yearly unrelated to the cause of hospitalization. Health professionals can benefit from this effective product to protect their patients and help fight C. difficile infection at a very low cost compared to C. difficile treatment.

"Although the company continues its R&D program, the clinical results published to date, on this unique product, have demonstrated its potential of reducing the risk of this prevalent disease. Health Canada's approval is further support for the product's role in prevention of C. difficile associated diarrhea," said Dr. Donald Low, Microbiologist-in-Chief at Mount Sinai Hospital in Toronto.

Making Our Healthcare System Safer
A Canadian hospital study found that of 136,877 hospital admissions, 1 in 100 patients will contract a C. difficile infection, and of those, 1 in 10 will die regardless of the initial reasons for admission.

"Bio-K+® is an innovative product that works to reduce the risk of hospital acquired or antibiotic-associated C. difficile infections. Health Canada's approval of Bio-K+® represents a milestone in further recognizing the importance of such products in the prevention landscape," said Dr. Ian Bookman, Gastroenterologist at St. Joseph's Health Center in Toronto.

In Quebec, there were 3,934 C. difficile infections resulting in 619 deaths (i.e. 16% of infected patients) between 2010 - 2011. Since 2004, the Pierre-Le-Gardeur Hospital in Montreal, reacting to a major outbreak, has used Bio-K+® on its formulary and also provides the product to all patients treated with antibiotics with no exclusion factors, as a risk reduction measure to control C. difficile.

"Our hospital has almost 9 years of pharmaco-vigilance with more than 40,000 patients using Bio-K+® products with no serious adverse events reported and we have maintained one of the lowest rates of C. difficile in the Province of Quebec," said Dr. Pierre-Jean Maziade, Microbiologist and Head Officer of Infection Preventions at Pierre-Le-Gardeur Hospital, Montreal.

Preventing C. difficile Infections Could Save Our Healthcare System Over $200 Million
Over the last decade, a virulent strain of C. difficile (NAP1/027) spread in hospitals and caused many outbreaks, which has resulted in increased patient deaths, increased human suffering and increased care costs related to this epidemic. The decreased rate of C. difficile following Bio-K+® administration to hospitalized patients translates into major financial savings as demonstrated in a 2012 published pharmacoeconomic study.

"A hospitalized patient who receives Bio-K+® 100 cfu administered concomitantly with the antibiotic therapy generates a cost-savings of $2,700 per patient versus a patient who receives the same antibiotics without Bio-K+® - a potential savings of over $200 million to our healthcare system annually. These savings come over and above reduction in mortality rate and recurrence cost associated with C. difficile," said Dr. Jacques LeLorier, Chief, Pharmacoepiodemiology and Pharmacoeconomic Research, Hotel-Dieu Hospital, CHUM, Montreal.

Health Canada's approval of Bio-K+® provides Healthcare Professionals an efficient tool in their daily practice to reduce C. difficile infection, save lives and reduce health care costs.

"This is an important step that will help thousands of patients. It will prevent unnecessary suffering, improve their general health and even save their lives. The healthcare system could also be saving millions of dollars." said Dr. Jacques Besson, President of the Association for Victims of Nosocomial Infections (ADVIN).

About Bio-K Plus International Inc.
Bio-K Plus International Inc. is a Canadian biotechnology company, committed to medical research and to develop breakthrough innovative products capable of improving human health and quality of life.  The company has over 100 employees in Canada and the United States. Bio-K+® is a quality probiotic product that is distinguished by its exclusive and patented formula. It is available in fermented drinks or enteric-coated capsules, dispensed in hospitals, pharmacies, health food stores and supermarkets in North America. The company is also GMP certified by NSF International. This certification confirms the commitment of the company to provide high quality products of international standards. www.biokplus.com

SOURCE: Bio-K+ International Inc.

For further information:

Dr. Serge Carrière
Managing Director, Scientific Affairs 
Bio-K Plus International Inc.

Isabèle Chevalier
Bio-K Plus International Inc.

Media Contact:  
Elizabeth Tanguay
Cohn & Wolfe | Montréal
Direct line: 514 845-7064 |cellphone: 514-627-6919

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