Full Press Release Details
Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok Therapy
CRANFORD, NJ - June 2, 2020 - Citius Pharmaceuticals,
Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing
and commercializing critical care drug products, today announced that it has received positive feedback from the Food and Drug
Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok therapy. The studies,
if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous
catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies
will meet European and world standards.
The ability to be labeled without restrictions with respect to catheter
type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central
line-associated bloodstream infections (CLABSIs), which are estimated to be over $1.5 billion per year worldwide. The catheter
compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced
in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is
the result of an interim efficacy analysis, which is expected to occur in the second half of 2020.
"We believe we continue to check all the boxes required for
an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius. "According to our planned dosing recommendations,
the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate,
but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended
for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients."
"The shorter dwell time for Mino-Lok also means that the catheter
is available for its intended purpose, allowing treatment for the underlying disease to continue. Additionally, and more importantly,
our pivotal trial is designed to show the superiority of Mino-Lok to standard antibiotic locks in time-to-catheter-failure. If
all these studies prove to be successful, we believe ready-to-use Mino-Lok will be superior to home-brewed antibiotic locks in
both efficacy and dosing schedules," Mr. Holubiak concluded.
Mino-Lok is an antibiotic lock solution used to treat patients with
CLABSIs and catheter-related bloodstream infections (CRBSIs) in combination with an appropriate systemic antibiotic(s) to preserve
central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion procedures.
It has the potential to change the standard of care, which currently calls for a procedure to remove and replace the infected catheter.
Each year, up to 500,000 CVCs of the 7 million used become infected and lead to CLABSIs, increasing both patient morbidity risk
and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria,
and there are currently no approved therapies for salvaging infected central venous catheters. According to DelveInsight, the market
size of CLABSIs and closely associated CRBSIs in the global market is expected to reach $1.84 billion in 2028, up from $1.24 billion
About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company dedicated
to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information,
please visit www.citiuspharma.com.
an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream
infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer
patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents
a challenge. There are currently no approved therapies for salvaging infected CVCs.
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements
are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by
the fact that they use words such as "will," "anticipate," "estimate," "expect,"
"should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking
statements are based on management's current expectations and are subject to risks and uncertainties that could negatively
affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ
materially from those currently anticipated are: risks of FDA acceptance of our compatibility studies and, if so, the successful
completion of and results from the studies; our need for substantial additional funds; the estimated markets for our product candidates,
and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including our Phase
III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing
our product candidates, including that preclinical results may not be predictive of clinical results and our ability to file an
IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development;
risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and
relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely
basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters;
competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations
or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.
Vice President, Corporate Development
(O) 908-967-6677 x105