GI Health in Dogs Undergoing Chemotherapy Treatment
Rockville, MD – ExeGi Pharma LLC, a leader in digestive health solutions, is proud to announce that its flagship product, Visbiome GI Care Probiotic Capsules, has achieved the prestigious Clean Label Project® Certification and Clean Label Project Pesticide Free Certification. The Clean Label Project is a national nonprofit consumer advocacy and standards development organization focused on health and transparency in consumer product labeling. Through its rigorous testing and certification program, the Clean Label Project ensures that products meet the highest standards for ingredient purity and quality. “Our customers trust Visbiome to support their digestive health with the highest-quality probiotics subjected to extensive clinical testing,” said Marc Tewey, CEO of ExeGi Pharma. “Securing the Clean Label Project Certification is a testament to ...
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Rockville, M.D., and Charlotte, N.C., April 12, 2023 – ExeGi Pharma LLC (“ExeGi”), a leading developer of live biotherapeutic drugs and probiotics, has announced a partnership with TannerLAC, Inc. (“TannerLAC”), a division of Tanner Pharma Group, to distribute Visbiome in Mexico. Visbiome is a high potency probiotic medical food designed to manage microbial imbalances associated with medical conditions such as irritable bowel syndrome (IBS), Ulcerative Colitis (UC), Antibiotic-Associated Diarrhea (AAD), Pouchitis, and Hepatic Encephalopathy (HE). With a proven track record in over 80 human clinical trials performed over the past 20 years, Visbiome is the most extensively researched multi-strain probiotic available. TannerLAC provides pharmaceutical, biotech, and healthcare companies with a single-point partner for the commercialization of their products in challenging international markets. Under ...
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April 5, 2023 – ExeGi Pharma, LLC, owner of the Visbiome probiotic, has secured a significant legal victory against Brookfield Pharmaceuticals, LLC. ExeGi alleged that Brookfield engaged in false advertising and unfair competition by promoting its High Potency Probiotic (“HPP”) as a generic equivalent of Visbiome. The United States District Court for the Eastern District of Wisconsin ruled in favor of ExeGi, entering summary judgment and finding Brookfield liable for false advertising under the Lanham Act. The court also issued a permanent injunction against Brookfield to prevent the company from making any such false claims in the future. The court found that the Brookfield HPP product has a different composition than that of Visbiome, and Brookfield attempted to pass off HPP as a Visbiome generic equivalent. In a 44-page opinion, Judge J.P. Stadtmueller ...
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Rockville, MD – January 26th, 2023 ExeGi Pharma LLC, a leader in the development of live biotherapeutic drugs and probiotics, announced today that the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or “J-Pouch”) who experience excessive stool frequency. “Excessive stool frequency is a significant challenge for many patients with a J-Pouch, and we are pleased to have the opportunity to investigate the potential benefits of EXE-346,” commented Dr. Hans Herfarth, MD, Ph.D., of the University of North Carolina Inflammatory Bowel Disease Center. And “We believe that the live biotherapeutic approach has the potential to ...
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November 12, 2020 (Rockville, Maryland): ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. This designation grants certain benefits to drugs and biological products intended to treat diseases which affect less than 200,000 patients in the U.S. EXE-346 is an LBP which contains a fixed-proportion of 8 strains of live probiotic bacteria which are intended for oral administration. Pouchitis is a condition which impacts patients who have had a surgical procedure to remove their colon. The surgery, called a pouch anastomosis, creates an intestinal “J-Pouch” ...
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ROCKVILLE, Md., July 13, 2020 ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy. COVID-19 crisis exploded in Italy and clinicians struggled to navigate patient care. Investigators at Policlinico Umberto I, “Sapienza” University of Rome hypothesis that a bacterial formulation, with a specific biochemical and immunological profile, could trigger the production of ...
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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 2016under 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 ...
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Claudio De Simone, inventor of high-potency probiotic, sued pharmaceutical companies for making false advertising claims, ownership rights to the product formula and unpaid royalties November 26, 2018 09:30 AM Eastern Standard Time GREENBELT, Md. – A federal jury on Tuesday, Nov. 20, unanimously ruled in favor of a probiotic inventor who sued his former business partners after an international dispute concerning false advertising, ownership of a proprietary formulation and unpaid royalties. The inventor accused his former partners of attempting to make a copy of his invention and selling it to unsuspecting patients under the same brand name, even though the copy product had never been clinically tested. The three-week trial in the U.S. District Court for the District of Maryland ...
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Clinical studies show a probiotic used to manage human GI disorders can help support bowel and gut health in dogs. ExeGi Pharma Launches a high potency veterinary probiotic for companion animals. ROCKVILLE, MD ExeGi Pharma LLC, a company focused on developing and commercializing live biotherapeutics and probiotic treatments, announced today the new Visbiome ® Vet. A new high potency veterinary probiotic for use in companion animals to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health. The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend. This formulation has recently been studied in several canine GI disorders with two clinical trials published in the last 12 months. Moreover, Visbiome Vet is ...
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http://www.businesswire.com/news/home/20170502006014/en/Multi-Strain-Probiotic-Play-Role-Recovery-Critical-Gastrointestinal ROCKVILLE, Md.–(BUSINESS WIRE)–A newly released study published in the Journal ofImmunity, Inflammation and Disease and conducted by the Sapienza University of Rome, Italy, found a multi-strain, high concentration, probiotic formulation that helped reconstitute the physical and immunological integrity of the gastrointestinal lining in HIV-1-positive patients on antiretroviral therapy (ART). The human gastrointestinal (GI) tract is home to trillions of organisms which form a complex bacterial community, commonly referred to as the “gut microbiome.” A key function of the GI tract is to separate these bacteria from internal organs with a single layer of intestinal cells, called epithelial cells. The epithelial cells form a physical and immunological barrier to prevent entry of gut bacteria into the bloodstream. When this barrier breaks ...
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