Is the future of women’s health probiotics medical?

On-pack probiotic claims possible with medical women's health products, says Danish supplier Bifodan

Danish probiotic firm Bifodan has created a second business unit for probiotics targeting women’s intimate health, splitting the business between dietary supplements and over-the-counter (OTC) medical products.

 

 

Niels Peter Bak, the company’s former vice president of marketing and business development, has been tasked with heading the new business unit. Bak told us this “strategic emphasis” showed the firm’s confidence in products that could address the common problem vaginal bacteriosis, as well as have potential within the areas of urinary tract infections, antiobiotic after-effects and even protect against preterm delivery and sexually transmitted diseases.  

Yet the nature of the application of its first product Ecovag – applied vaginally as opposed to being taken orally – meant the product was the company’s first venture away from dietary supplements into the medical arena. He said in this respect the area of women’s intimate health differed from other areas within probiotics.

The private-label supplier believed this was the fasted growing area within probiotics, but acknowledged it was a niche area.  

A regulatory split

On a regulatory level this meant the product would be governed by national medical authorities, with an application to each required.

“For the OTC drugs the requirement for [scientific] documentation is significant and goes much beyond that for food supplements.”

This included a record of clinical trials for the product itself.

This also meant that, unlike in the case of food supplements, the term ‘probiotic’ could be used on pack, as opposed to just listing the strains the product contained.

“You are able to make claims. For instance, the Scandinavian approval allowed the claim that it prevents and treats itching, dryness, odor and discharge due to a microbial imbalance.”

Asked if this ability to make claims on pack might tempt the firm to consider the medical route for other probiotic products, he said it was a possibility but Bifodan was a small to medium sized firm and this required huge investment.

He said its women’s health product had been ten years in development considering the selection of strains, documentation and registration as an OTC. He added that this route had been the only possibility for the vaginal product, given it is applied locally, unlike its other food supplement probiotics.

A niche with wider potential

Europe was currently the biggest market by far for women’s probiotics, but promise had been seen in other countries like Canada, Australia and South Africa. Outside of Europe though he said vaginal probiotics were not common.

“But really the issues these probiotics can address are not just European issues.”

Vaginal bacteriosis, or vaginosis, a common condition which occurs when the balance of bacteria inside the vagina becomes disrupted, was the firm’s main focus but Bak said potential extended well beyond this.

Antibiotics cause imbalances for some women when all bacteria, good and bad, is wiped out. Bak envisioned a treatment whereby women may take a course of probiotics after the course of antibiotics to counter this effect. This idea of pre-infection, and more generally when women are prone to these issues or have slight discomfort not severe enough to seek medical advice, was key. 

This could also be helpful in the indirect prevention of preterm delivery, he said, since infections could trigger this.

Urinary tract infections was also an important area, as was the idea of strengthening the lining of the vagina which its strains had been specifically selected for and he said may help limit the risk of sexually transmitted diseases like gonorrhea. 

“This is just the tip of the iceberg,” he said. 

He said educating doctors, gynaecologists and pharmacists would be key in getting this message to women.   

Further investments

Bak declined to comment on what percentage of the businesses budget would be committed to this new unit but said it was an important area despite the fact that food supplements still dominate the company’s total sales.

The unit is one of two in the company, the first covering food supplements including one cranberry women’s health product.  

Bifodan has not been the only firm to commit to women's probiotics. Late last year Lallemand Health Solutions launched a range of probiotics addressing women’s health issues. Winclove made a similar launch way back in 2009. Bifodan's own EcoVag range dates back to the same year. 

Probiota 2015

Pre- and probiotics will be discussed at Probiota 2015 in Amsterdam on February 3-5 – less than a month away.

From the next wave of prebiotics to the future of microbiome science beyond probiotics and prebiotics, to the nutrients’ effect on mood and anxiety, and strategies on pre- and probiotic market building, Probiota 2015 is a knowledge store you probably shouldn’t miss.

Click here for more.

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