Alliospharma general manager Sami Bou Antoun told NutraIngredients.com this morning that the prebiotic solution his company had worked on for three years had demonstrated benefits to the estimated one-in-six women who suffer from bacterial vaginosis (BV).
The capacity of the unspecified prebiotic to deliver such benefits had been demonstrated in an unpublished double-blind, placebo-controlled, clinical study Bou Antoun said was being prepared for peer review.
Bou Antoun said the product will be marketed as a medical device in EU member states and be available over-the-counter in pharmacies.
The product will feature in Merck Consumer Health Care Holding GmbH’s Femibion range and Merck will be responsible for all marketing and distribution of the product in as yet unspecified European markets.
A Merck spokesperson said the product would launch in 2011 as the company was, “following approval procedures that are relevant to medical devices”.
“We don’t have the exact claim approved as yet,” he said, noting the company was also considering the latin American and Asian markets and may submit the same dossier to regulators in those markets. But the arrangement does not extend to North America.
“The regulations are quite different there so we’ll see if the dossier will stack up.”
Typically probiotic strains such as Lactobacillus rhamnosis or antiobiotic drugs are used by women trying to treat vaginosis, but Alliospharma said antiobiotics are less effective during relapses, which occur in one third of cases.
Bou Antoun said Merck was in the process of finalising the kinds of claims the products would utilise, after which the product would launch.
He said because the product is classified as a medical device because it is not consumed orally, the claims do not pass through the EU nutrition and health claims system, but rather under separate rules specific to medical devices.
“After a long development period, we are happy to collaborate with Merck for the commercialization of this product, which is an important component of our growth strategy” Bou Antoun said in a statement.
“Merck enjoys a solid experience in the field of women’s health. Its presence in high-potential markets and its sales force are major assets for the distribution of this MD as the first real alternative to antibiotics in BV”.
Merck director of business development, Oliver Bittner,added in the statement that, “we are happy about this collaboration, as this new prebiotic-based MD product further diversifies the Femibion brand architecture and supports women in their style of active living”.
Vaginosis can lead to vaginal infection which can result in unpleasant odours as well as itching, swelling, irritation and stomach cramps.
Bou Antoun said his company was investigating the inflammation/arthritis and weight management markets.