Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT) has been granted Qualified Infectious Disease Product (QIDP) status for the Botanix novel cannabidiol antibacterial product, BTX 1801 by the US Food and Drug Administration (FDA).
The new QIDP status covers usage of BTX 1801 for the “reduction of risk of S. aureus bloodstream infections in colonised patients on central venous catheter-dependent hemodialysis” which is the lead indication for the novel synthetic cannabidiol intranasal gel.
The FDA had previously granted QIDP designation for BTX 1801 for the prevention of post-surgical infections.
Botanix President and Executive Chairman Vince Ippolito, said this new designation represents the first such designation ever granted for a nasal decolonization agent for hemodialysis patients.
Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access,” Mr Ippolito said.
“These life-threatening infections in this vulnerable population are estimated to cost the US health system more than $360 million annually.”
QIDP is a US FDA programme designed to provide incentives for the development of novel antibacterial or antifungal products.
To be considered for this designation, product candidates must fulfil a strict set of qualifying criteria that demonstrate the product’s novelty and its potential to treat a serious or life-threatening disease.
The major incentive afforded to a product with QIDP status is an additional five years of regulatory exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA). This incentive could potentially enhance the value of a successful product as it provides an extra five years of protection, during which period, generics cannot enter the market.
Successful QIDP recipients are also eligible for NDA “priority review”, which provides an expedited six month FDA review period, rather than the standard 12-month review period.
Finally, “fast-track designation” enables Botanix to have more frequent communication with the FDA during the drug development and review process, thereby enabling valuable guidance to be included in its development programme.
Botanix has recently completed additional pre-clinical and animal studies to support its planned Phase 2 study, which remains on track to initiate in 2Q 2022 in Australia.
