Microbion Granted Qualified Infectious Disease Product (QIDP) Designation for Adjunctive Treatment of Moderate and Severe Diabetic Foot Infections From U.S. FDA for MBN-101
BOZEMAN, MT and VANCOUVER, BC – (Marketwired) – Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, today announced that the U.S. Food & Drug Administration (FDA) has granted MBN-101, Microbion’s lead compound, Qualified Infectious Disease Product (QIDP) designation for the adjunctive treatment of moderate and severe diabetic foot infections. The QIDP designation program was established by the U.S. Congress in 2012 as part of the Generating Antibiotic Incentives Now (GAIN) Act in order to provide incentives to drug manufacturers to develop new antibiotics for serious, antibiotic-resistant, bacterial and fungal infections.
MBN-101 is the lead compound in a new class of drugs that Microbion is developing to combat difficult to treat infections, including multi-drug resistant infections. Microbion believes that MBN-101 is the first and only product in a new class of drugs to receive QIDP designation by the FDA for adjunctive treatment of moderate and severe diabetic foot infections. The QIDP designation allows MBN-101 to be eligible for additional incentives for product approval and marketing. As part of the QIDP designation, MBN-101 may be eligible for Fast Track designation and Priority Review for the adjunctive treatment of moderate and severe diabetic foot infections. Having been granted this designation also provides five years of market exclusivity in addition to Hatch-Waxman exclusivity.
In 2013, Microbion was granted QIDP designation for MBN-101 for the treatment of post-surgical orthopedic implant infections. Having been granted QIDP designation for this indication, MBN-101 will also receive five years of market exclusivity in addition to Hatch-Waxman exclusivity and may also be eligible for Priority Review.
“We are very pleased that we were able to gain a second QIDP designation from the FDA for MBN-101 to now include diabetic foot ulcer infections,” stated Karim Lalji, Chairman & CEO of Microbion. “Together with both the QIDP and Fast Track designations the FDA has granted for orthopedic device-related infections, we can move more quickly to bring MBN-101 closer to approval for patients who need new therapies. This should allow patients to benefit from what will likely be the first new class of antibiotics to treat diabetic foot ulcer infections and orthopedic infections — two serious medical conditions with high unmet medical need. We look forward to quickly advancing two important clinical programs with MBN-101.”
Fast Track Designation
In 2015, the FDA granted MBN-101 Fast Track Designation for the treatment of post-surgical orthopedic implant infections.
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly reduce the development time and cost associated with bringing a drug to market.
Microbion is currently enrolling patients in a clinical trial at multiple sites in the United States for the treatment of post-surgical orthopedic implant infections.
About Chronic Wounds and Diabetic Foot Ulcers
Chronic wounds are wounds which have failed to heal effectively and in a timely manner. Chronic wounds affect approximately six million patients in the United States on an annual basis. The most common risk factors for developing chronic wounds include diabetes, vascular disease, and obesity. Bacterial infection and microbial biofilms are considered one of the main causes of impaired healing in chronic wounds. The most common chronic wound types are diabetic foot ulcers, venous leg ulcers and pressure ulcers. Chronic wounds represent a significant burden to patients, healthcare professionals and the U.S. healthcare system, costing an estimated $25 billion dollars annually. There are over 70,000 amputations annually on diabetic patients in the United States and 80% of diabetic amputations are preceded by an ulcer. There are over 100,000 hospitalizations in the U.S. annually for diabetic foot ulcers.
About Orthopedic Device Related Infections
There were over 2 million device-related orthopedic surgeries in the United States in 2015. There are also approximately 1 million traumatic fractures in the United States annually. The infection rate related to the above conditions/surgeries can reach up to 20% in patients with risk factors including morbid obesity, diabetes, and smoking, with significant patient morbidity and economic burden to the healthcare system. The cost of infected hip and knee replacements alone is projected to be over $1 billion annually in the United States.
About Microbion Corporation
Microbion is a clinical stage biopharmaceutical company. Microbion is developing MBN-101 as the first product in a new class for the treatment of resistant and difficult to treat infections. MBN-101 has broad spectrum, anti-bacterial efficacy against a broad range of pathogens, including multiple priority pathogens or “superbugs.” In addition to anti-bacterial efficacy, MBN-101 has also demonstrated the ability to eradicate biofilms. This dual antimicrobial action from this first-in-class product provides a novel clinical approach to treating infections. Microbion filed an IND in the United States for MBN-101 in 2015. The company initiated its first Phase 2a study in 2016. MBN-101 has been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for post-surgical orthopedic implant infections and was also granted Fast Track status for this indication by the FDA in 2015. The company has also been granted QIDP Designation by the FDA for adjunctive treatment of moderate and severe diabetic foot infections.
Safe Harbor Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of MBN-101 and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for MBN-101 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of MBN-101 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of MBN-101 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Karim Lalji, Chairman & CEO
Microbion Pharma Corp.