MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announced that the US Food and Drug Administration (FDA) has granted MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated Diarrhoea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.
MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of cases of infectious hospital-acquired diarrhoea in developed countries.
Successful completion of the clinical phase I study of MGB-BP-3 confirmed the compound was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora. MGB is preparing to initiate the phase II clinical study for MGB-BP-3 and investigate the safety and efficacy in patients with CDAD, caused by the most virulent ribotype of C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.
Dr Miroslav Ravic, CEO of MGB Biopharma, said, “We are very pleased with the FDA’s decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhoea (CDAD). Granting of the QIDP designation highlights the potential of MGB-BP-3 to address serious and life-threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the phase II clinical trial.”
Dr Ravic, added, “Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit. Our MGB-based anti-infectives have the potential to deliver significant advantages over current approaches.”
While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.
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It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo
being hosted at the
DoubleTree by Hilton — Atlanta Airport
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA (Hotel Phone: 1-404-763-1600)
Doors open at 7:15 a.m — Sign In and Continental Breakfast
Conference begins at: 7:30 a.m. – 5:00 p.m.
Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.
“None of us can do this alone — All of us can do this together”
Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC). C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA. Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.
Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —
- Environmental Safety
- Clinical trials and studies
- Microbiome research, studies
- Infection Prevention
- Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
- A Panel Of C. diff. Infection Survivors
- Antibiotic Stewardship
- Healthcare EXPO
……………………and much more.
You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.
Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.
5 Leading reasons to attend this dynamic conference:
- Learn from leading healthcare professionals, clinicians, researchers, and industry.
- Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
- Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
- Implement and share the knowledge well after the conference ends. Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
- Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.
“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.” Linda Davis, RN,BSN
$75.00 — Conference Registration
$30.00 — Student Conference Registration (Student ID To Be Presented At the Door)
TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below
Room accommodations are available — Complete and Confirm
by August 19th to reserve your hotel reservations.
To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –
A suggested travel coordinator, for your convenience
For Additional Information visit the C Diff Foundation Website:
And Click on the 2016 September Conference Tab
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ANI Pharmaceuticals, Inc. today announced the launch of Vancomycin HCl 125mg and 250mg capsules indicated for treatment of C. difficile-associated diarrhea.
The overall US market for Vancomycin HCl Capsules is approximately $113 million, per IMS Health.
Arthur S. Przybyl, President and Chief Executive Officer said, “We are pleased to announce the launch of our authorized generic to Vancocin, which replaces the authorized generic previously on the market. This is the second of four generic products we plan to launch before the end of 2015, having previously announced the launch of Oxycodone Oral Solution in October. The launch of an authorized generic for one of our acquired branded products represents an important value driver for ANI and a key component of our mature brand strategy.”
About Vancomycin HCl Capsules
Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile-associated diarrhea (CDAD).
Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.
ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.
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