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PRZOOM - /newswire/ -
Muenster, North Rhine-Westfalia, Germany, 2010/03/01 - German pharma service companies Diapharm and Med Pharma Service have developed a Lactobacillus johnsonii product for the regeneration of intestinal functions for non-specific or antbiotics-induced diarrhoea that works in a purely physical manner.
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The pharmaceutical service provider Diapharm (diapharm.com) and the contract manufacturer Med Pharma Service (medpharmaservice.de) have succeeded in developing an innovative medical device that works naturally for the regeneration of intestinal functions for non-specific diarrhoea or for diarrhoea after antibiotics therapy. Together, these two companies have brought the new medical device with the eubiotic Lactobacillus johnsonii to market. The hard capsules will be sold as a class III medical device under the trade names of selected sales partners. “The certification by the notified body is already completed, which means that the product is now marketable,” says Dr Annemarie Jasper, who manages the development project for Diapharm.
The medical device contains the eubiotic strain Lactobacillus johnsonii EU1. It will be used for support in cases of disturbed normal, bacterial population in the human small intestine and for the restoration of the small intestinal mucosa function, e.g. in cases of continual diarrhoea of unknown origin or for cases of diarrhoea after antibiotic therapy. “With this development, an effective medical device against digestion problems can be offered – a clear medical indication, combined with an optimal position on the shelves,” points out Dr. Annemarie Jasper.
In this combination, she sees the main advantage of this device over a typical medicinal product or food supplement: “Due to the non-transparent claims of the EFSA, which have kept, for example, those requiring therapy from participating in clinical studies, significant health claims for food supplements appear to have receded into the distance. And an attempt to get a marketing authorisation for a medicinal product with a pharmacological mode of action would have meant an extremely long delay before authorisation,” explains Jasper.
Diapharm also provides a solution to the obstacle for class III medical devices – the manufacturer certification required by the medical device standard ISO 13485: licensees can transfer the legal function of the manufacturer to Diapharm and thereby bring the product immediately to market without undertaking all the efforts required for certification. At this time, Diapharm is negotiating with partners in several European countries, who would like to bring class III medical devices to market under their own trade names.
More information is available from Dr Annemarie Jasper, Diapharm GmbH; T: +49 (0)251 60935-544, E: annemarie.jasper[.]diapharm.de.
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