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Visbiome GI Care High Potency Capsules Now Certified By The Clean Label Project® standard

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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Visbiome Probiotic Prevails In Landmark False Advertising Lawsuit Against Competitor Brookfield Pharmacuticals standard

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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ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug standard

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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First Published Clinical Trial Using Live Biotherapeutic Candidate in COVID-19 Patients Suggests Role In Improving Outcome standard

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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ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers standard

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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Maryland Federal Jury Unanimously Finds Probiotic Sellers Liable for False Advertising and Awards Product Inventor More than $18 Million in Damages standard

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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EXEGI PHARMA LAUNCHES HIGH POTENCY VETERINARY PROBIOTIC standard

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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Visbiome Probiotic May Play a Role in Recovery of GI Functions in HIV Patients standard

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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ExeGi Pharma Recognizes World AIDS Day standard

ROCKVILLE, MD., Dec. 1, 2016– December 1st marks the observation of the 28th World AIDS Day, a day dedicated to the fight against HIV, those who have lost their lives to AIDS, and those currently living with HIV. ExeGi Pharma recognizes World AIDS Day and reaffirms its commitment to the research of Visbiome, a high potency multi-strain probiotic, in restoring the microbiome of people living with HIV. Visbiome is a medical food which is currently the subject of two ongoing, publically sponsored, clinical trials, in the United States and Canada, evaluating the safety, tolerability, and effect of Visbiome on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART). World ...

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ExeGi Pharma Partners with NIH-Funded AIDS Clinical Trials Group to Study Probiotic in People Living with HIV standard

Researchers will explore potential role of probiotics in immune activation GAITHERSBURG, Md., Aug. 18, 2015 /PRNewswire-USNewswire/ — ExeGi Pharma has announced participation in a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to study the probiotic Visbiome™ in people living with HIV. Conducted by the NIH-funded AIDS Clinical Trials Group (ACTG), the study will evaluate the safety, tolerability and effect of probiotics on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART). In early stages of HIV infection, both the immune function of the gastrointestinal tract and its microbiome are altered and fail to normalize, even when ...

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