Replies to post #3078 on RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals
28 January, 2021

New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains

TEL AVIV, Israel and RALEIGH, NC, January 28, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640)1, to address prospective demand subsequent to potential global emergency use authorizations.

“The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics.” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo’s quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. By targeting SK2, a human cell component involved in viral replication irrespective of mutations in the viral Spike protein, opaganib potentially addresses the emergence of new strains.”

“We are delighted to further strengthen our partnership with RedHill on expanded opaganib manufacturing, and to play a part in trying to help alleviate the suffering the coronavirus pandemic is causing across the world, should opaganib be approved for use,” said Davide Malavasi, Cosmo’s Head of Manufacturing.














https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=4457&PID=0&IID=19325

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AEMCOLO® Produced by Cosmo:

Home /Products / AEMCOLO®
Aemcolo® is a pharmaceutical drug product containing rifamycin SV formulated with the MMX® technology. Aemcolo® contains a broad spectrum, semi-synthetic, orally non-absorbable antibiotic, and has been approved in the US and in the EU for the treatment of traveler’s diarrhea caused by non-invasive E. coli strains. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo® tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus avoiding its systemic absorption in the small intestine.

Aemcolo® is the first FDA approved antibiotic for the treatment of travelers’ diarrhea in over a decade and is now marketed by RedHill Biopharma in US.
In addition, Dr. Falk Pharma, our licensee, has received approval in EU through the European Decentralized Procedure (DCP) for Relafalk for the treatment of travelers’ diarrhea. In a phase 3 clinical study against ciprofloxacin in traveler’s diarrhea, patients treated with ciprofloxacin had a significant increase in the colonization rate by Extended Spectrum ß-Lactamase-producing (ESBL) Escherichia Coli, whereas patients treated with Aemcolo® were not. Extended-spectrum beta-lactamases (ESBL) are enzymes that confer resistance to most beta-lactam antibiotics, including penicillins, cephalosporins, and the monobactam aztreonam, also including many fourth generation cephalosporins. This provides an important advantage in view of the recent concerns regarding the emergence of multi-drug resistant bacteria, whose infections are challenging to be treated.