Dublin, Ireland – November 19, 2018 – Cosmo Pharmaceuticals N.V. (SIX: COPN) announced that the U.S. Food and Drug Administration (FDA) has approved AEMCOLO™ (Rifamycin), containing 194mg of Rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO, AEMCOLO should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for AEMCOLO. With the QIDP designation, intended for antibacterial or antifungal drugs that treat serious or life-threatening infections, together with new chemical entity (NCE) designation, marketing exclusivity for AEMCOLO runs through 2028. AEMCOLO will be available in pharmacies in the first quarter of 2019.
Travelers’ Diarrhea is the most predictable travel-related illness with bacteria, the most common of which is E. coli. “The approval of AEMCOLO for Travelers’ Diarrhea is a major step for Cosmo and just the starting point for an exciting development path. AEMCOLO has all the features to become over time a very significant asset in our portfolio to address important unmet needs in the GI community”, said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals.
Dr. Herbert Dupont, Professor for Infectious Diseases at The University of Texas-Houston School of Public Health and primary investigator said, “given the potential seriousness of Travelers’ Diarrhea and growing resistance to antibiotics that have been in widespread use since the early ‘90s, it’s important to have a new option for treatment. Because AEMCOLO is a minimally absorbed, colon-targeted antibiotic, it will be an important new option for patients.”
AEMCOLO was approved based on data from two randomized, multi-center, controlled Phase 3 clinical trials. In both trials AEMCOLO was dosed at 388mg twice daily for three days. AEMCOLO demonstrated superiority to placebo (p= 0.0008) and non-inferiority to Ciprofloxacin (p= 0.0011) for the primary endpoint (time to last unformed stool). The common adverse reactions that occurred ~2% of AEMCOLO-treated patients in these clinical trials were constipation 3.5% and headache 3.3%.
About AEMCOLO
AEMCOLO™ (Rifamycin) is an orally administered, minimally absorbed antibiotic approved for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. AEMCOLO is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®) which allows for the colonic release of active ingredient. AEMCOLO is also being studied for IBS-D and uncomplicated diverticulitis.
Indication: AEMCOLO is indicated for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults.
Limitations of Use: AEMCOLO is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than non-invasive strains of Escherichia coli.
Contraindications: AEMCOLO is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in AEMCOLO.
Adverse Reactions: Discontinuation of AEMCOLO due to adverse reactions occurred in 1% of patients. The most frequent adverse reactions were abdominal pain (0.5%) and pyrexia (0.3%). The common adverse reactions that occurred in ~2% of AEMCOLO-treated patients in the clinical trials were constipation 3.5% and headache 3.3%. Full prescribing information for AEMCOLO is available at www.ariespharma.com
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company has developed and launched Eleview, a medical device for polyp and adenoma excision, in the U.S. and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer. In addition, new chemical entities are being developed by its associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX drugs already on the market are Lialda/ Mezavant/Mesavancol, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment. Cosmo’s proprietary MMX technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com
Next events
Berenberg European Corporate Conference December 5, 2018
Full-year results 2018 reporting March 2019
Annual General Meeting May 2019
Contact:
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
jmanieri@cosmopharma.com
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