The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act implemented in 2012 to give important incentives to facilitate the development of new antibacterial and antifungal drug products intended to treat serious or life-threatening infections. As part of the QIDP designation, Adjutec will gain access to certain regulatory incentives such as:
- Priority Review to the first application for which QIDP designation was granted
- Eligible for Fast Track designation, for some or all the following:
- More frequent communication including meetings with FDA to discuss the drug's development plan
- Eligibility for Accelerated Approval
- Rolling Review, meaning that a Adjutec can submit completed sections of its New Drug Application for review by FDA, rather than waiting until every section is completed
- A five-year non-patent exclusivity extension
Bjørn Klem, AdjuTec Pharma CEO, comments “The QIDP designation is a recognition from FDA of the potential value of APC148+meropenem for the US Healthcare Service. With a QIDP designation FDA is committed to fast-track development and approval of APC148+meropenem to meet the emerging threat of antimicrobial resistance. Adjutec will keep close contact with the Agency to benefit from their advice and review procedures.”
About antimicrobial resistance (AMR) – https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
AMR is a global health and development threat. It requires urgent multi-sectoral action in order to achieve the Sustainable Development Goals (SDGs). WHO has declared that AMR is one of the top 10 global public health threats facing humanity. Misuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. Lack of clean water and sanitation and inadequate infection prevention and control promotes the spread of microbes, some of which can be resistant to antimicrobial treatment. The cost of AMR to the economy is significant. In addition to death and disability, prolonged illness results in longer hospital stays at intensive care units and isolate wards. In addition, there is a need for more expensive medicines and financial challenges for those impacted. Without effective antimicrobials, the success of modern medicine in treating and preventing infections during major surgery and cancer chemotherapy, can be jeopardized.
About AdjuTec Pharma
AdjuTec Pharma is a Company that is dedicated to developing and providing novel antibiotic resistance breakers to the global market. The Company technology offers a unique mechanism of action that inactivates bacterial defense enzymes and restores bacterial sensitivity to antibiotics. The Company lead product is APC148, a selective zinc chelator targeting bacteria metallo-ß-lactamase (MBL) enzymes. The technology is developed by Professor Pål Rongved and his group at Department of Pharmacy, University of Oslo. The Company is located at Oslo Cancer Cluster Innovation Park next to the Radium Hospital, Oslo.
For more information, please visit www.adjutecpharma.com
Please contact: info@adjutecpharma.com