Antimicrobial drug resistance is recognised as a global public health concern. There is a heightened need for new antibacterial drug classes that are more effective than existing treatments. MGB Biopharma’s novel class of antibacterials look more promising than existing products, owing to their quick onset of action and strong bactericidal activity against many strains of Gram-positive bacteria.
Health authorities in the US and Europe are starting to recognise the scale of the problem, as indicated by initiatives such as GAIN (Generating Antibiotic Incentives Now), which is expected to facilitate a faster and less expensive process in bringing novel antibacterial agents to market. The GAIN Act was enacted as Title VIII of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to encourage the development of antibacterial and anti-fungal drug products that treat pathogens that cause serious and life-threatening infections.
MGB Biopharma has been a key beneficiary of GAIN, with 7 of the 21 pathogens listed in the 2012 GAIN Act being sensitive to MGB-BP-3, resulting in QIDP designation for our liquid-filled capsule presentation (2016) and our tablet presentation (2019), the latter of which was also granted Fast Track designation (2019) for priority review.
Furthermore, in a market currently valued at $630 million, MGB Biopharma is expected to play a key role in developing truly novel anti-infectives that would offer significant benefits to society, whilst also providing attractive returns to the Company’s shareholders.