ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers Posted on 26 Jun 08:31

Federal district court finds in favor of ExeGi and probiotic inventor, prohibits VSL#3 sellers from citing studies on original formulation

ROCKVILLE, Md., June 25, 2019 /PRNewswire/ -- ExeGi Pharma LLC is pleased to announce that on Friday, June 21, the United States District Court for the District of Maryland ruled in favor of a probiotic inventor and his business partner, ExeGi Pharma, LLC, in post-trial motions concerning the probiotic product VSL#3®. The ruling concludes over four years of litigation in which the inventor of the well-studied De Simone formulation probiotic (sold until July 2016 under the name VSL#3) sought to defend his ownership rights and prevent his former business partners from claiming that a reverse-engineered imitation product was, in fact, his own formulation.

On November 2018, a federal jury unanimously found in favor of the plaintiffs, inventor Professor Claudio De Simone and ExeGi, awarding over $18 million in damages for violations including false advertising under the Lanham Act. De Simone proved that, after leaving his long-term partnership with VSL Pharmaceuticals, VSL attempted and failed to reverse-engineer his formula. De Simone's original formulation had been studied extensively and established as a "medical food" for dietary management of serious gastrointestinal issues, such as ulcerative colitis and irritable bowel syndrome (IBS). VSL launched their version of VSL#3, an untested imitation product, without informing patients or physicians of the change.

Following the jury finding, the defendants (VSL Pharmaceuticals Inc., Leadiant Biosciences, and Alfasigma USA, Inc.) filed post-trial motions against key jury findings and requested a new trial. The Court denied each motion and affirmed that the original VSL#3 product containing De Simone's formulation was materially different from the imitation. The Court also found that, in marketing their product as the original, the defendants had advertised falsely with the intent to confuse or deceive the public.

Citing public health and wellbeing, the Court also issued a permanent injunction preventing the defendants from linking their product with the original De Simone formulation in other ways, including by citing clinical studies that were, in fact, performed only on the De Simone formulation. To date, more than 70 human clinical trials have been conducted on the original formulation, currently sold as VISBIOME®.

Marc Tewey, CEO of ExeGi, said: "We are very pleased with Friday's rulings. Ultimately, they will help protect the countless patients depending on VISBIOME® from further marketplace deception. We hope this sends a message to other probiotic manufacturers and resellers that not all probiotics are the same. Quality and testing matter when it comes to products with health implications and we will go to any lengths necessary to protect patient safety." 

About ExeGi Pharma 
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

About Claudio De Simone 
Claudio De Simone, MD, PhD, is an internationally recognized scientific leader in the field of probiotics and the human gut microflora. Professor De Simone invented the formulation of the probiotic tested and currently sold under the name VISBIOME®, which has been the subject of more than 70 clinical trials and is used for the dietary management of pouchitis, IBD and IBS. In addition, Professor De Simone has authored over 200 published scientific articles, reviews, case reports and book chapters.

*VSL#3 is a registered trademark of VSL Pharmaceuticals Inc.