CRANFORD, N.J., Sept. 22, 2020 /PRNewswire/ -- 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 achieved a number of significant milestones over the past
several weeks for Mino-Lok®.
Mino-Lok is an antibiotic lock solution being developed as an
adjunctive therapy for patients with central line-associated
bloodstream infections (CLABSIs) or catheter-related bloodstream
infections (CRBSIs). Mino-Lok contains three active drug substances
(minocycline, ethanol and EDTA) which are combined into two vials,
MLT01 (minocycline) and MLT02 (ethanol and EDTA). Citius has
manufactured three registration lots of Mino-Lok using the
commercial manufacturing process, which will be filed in the
planned New Drug Application (NDA). Citius has placed all
registration lots on stability at the appropriate ICH (The
International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use) conditions to support the NDA
filing. Citius has also developed a new exclusive synthesis process
for disodium edetate ("EDTA"), a chelating agent which supplants
heparin as the anti-clotting agent in Mino-Lok.
NDAs are applications to request permission to market a drug
product in the U.S. for a specific use. Chemistry, manufacturing,
and controls (CMC) information is therefore submitted in the NDA to
ensure product quality as it relates to the safety and efficacy of
the drug product.
"A typical drug approval contains one drug substance, so for all
practical purposes our team has developed three products. Mino-Lok
is unique in many ways, this being one of them," said Myron Holubiak, Chief Executive Officer of
Citius. "It's important to know that we expect to be prepared to
immediately move to validation/commercial manufacturing upon the
completion of our Phase 3 clinical trial and receiving the required
FDA clearance."
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.
About Mino-Lok®
Mino-Lok® is 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.
Safe Harbor
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
associated with conducting clinical trials and drug development;
our dependence on third-party suppliers patent and intellectual
property matters; market and other conditions; our ability to
attract, integrate, and retain key personnel; our need for
substantial additional funds; the risk of successfully negotiating
within the option period a license agreement with Novellus, Inc.
for our planned NoveCite therapy for ARDS; the estimated markets
for our product candidates and the acceptance thereof by any
market; risks related to our growth strategy; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; the early stage of
products under development; 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;
government regulation; 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.
Contact:
Andrew
Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(M) 646-522-8410
ascott@citiuspharma.com
View original
content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-achieves-chemical-manufacturing-and-control-milestones-for-mino-lok-301135361.html
SOURCE Citius Pharmaceuticals, Inc.