FleurirABX is a specialized drug development company founded by highly experienced scientists and executives in order to seize new opportunities for novel, underutilized and underdeveloped antibiotics, and effectively address the global burden of drug resistance measured by loss of life and economic costs.
Antibiotic resistance has become a worldwide crisis, threatening human health and burdening healthcare systems. Treatment alternatives are diminishing and development of effective new drugs has not kept pace. A changing regulatory paradigm in the US and elsewhere creates new opportunities for economically feasible anti-infective therapeutics. There are more attractive incentives to develop new drugs as well as to reposition existing drugs, including clarity of study endpoints, shortened review times, and improved exclusivity. The 2013 GAIN (Generating Antibiotic Incentives Now) Act demonstrates awareness, at the highest levels, of the urgency of growing drug resistance. Importantly, GAIN defines xx Qualified Infectious Disease Product (QIDP) categories of the most critical pathogenic threats and provides for 5 years of additional market exclusivity and FDA Priority Review that potentially shortens review period to 6 months. Antibacterial clinical study design guidelines are also being revised to mitigate some uncertainty and risk for developers.
FleurirABX seeks to selectively identify opportunities to maximize the value of anti-infective therapeutics, define optimal product development strategies and prosecute these strategies effectively. Addressing high unmet clinical need, alleviating direct and indirect economic burden and delivering value to partners and investors are equal and achievable criteria for FleurirABX programs. FleurirABX’s scientific and product approaches include repositioning, expanding, improving and/or combining underutilized therapeutics and skillful development of novel anti-infective agents.
FleurirABX enters into collaborate and/or transactional arrangements with other pharmaceutical companies in order to access drugs of interest for FleurirABX programs and to be a partner of choice for anti-infective development. We bring passion, expertise, focus, skills and business model flexibility to collaborations. Whether a compelling pre-clinical drug candidate, a branded drug or a currently generic drug, FleurirABX offers partner organizations the opportunity to increase and capture the value of anti-infective assets through a range asset-specific business relationships and transaction types dependent on the priorities of the partner and the risk profile of the development program. These include assets sales, equity participation, joint ventures, buyback options and marketing and supply agreements. See “Partnering” for more information about how to contact us.
FleurirABX can contribute to resolving the global unmet need for new antibiotic treatments by capitalizing on the evolving regulatory environment in the US with the right partners.