Full Press Release Details
Citius Pharmaceuticals Shareholder
Dear Citius Pharmaceuticals, Inc. Shareholder:
I am pleased to report on some of the recent
developments at Citius Pharmaceuticals (Nasdaq: CTXR), most notably, the successful listing of our shares on the Nasdaq.
We believe that our presence on a more senior exchange will improve the visibility of our stock, enhance
trading liquidity and provide access to larger audience of retail and professional investors. We can now also begin targeting
coverage from both buy-side and sell-side financial analysts. I believe that our uplisting places us at an inflection point in
our current growth trajectory. Additionally, we have recently completed a capital raise, of which our Chairman, Mr. Leonard Mazur,
invested $1.7 million (25% of the total), due to his belief and enthusiasm for Citius.
As you know, Citius Pharmaceuticals is a specialty
pharmaceutical company dedicated to the development and commercialization of critical care products. We are currently focused on
developing and commercializing our proprietary product, Mino-Lok , which is an antibiotic solution used to treat patients
with bacteremia due to their infected venous catheters. This very serious condition is called "Catheter
Related Blood Stream Infection" or (CRBSI). We also are progressing "Hydro-Lido" which is a topical prescription-strength
cream used for the treatment of hemorrhoids. Both markets represent a significant market opportunity. We believe the global
market for Mino-Lok as treatment for CRBSIs exceeds $750 million, while hemorrhoids affect
5% of the US population, more than 10 million people, and could be a $500 million market opportunity in the U.S.
Operational Highlights from the Current
FDA Recognition of Unmet Medical Need
The Company received
feedback from the U. S. Food and Drug Administration (FDA) regarding amendments to the phase 3 study plan for Mino-Lok .
There are currently no approved therapies to salvage infected CVC's. Most guidelines require the infected catheter to be
removed and replaced, a costly process that causes discomfort for the patient and is associated with morbidities.
that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority
design would address the Company's concerns and would be acceptable. They also reinforced their commitment to work with the Company
to assure the trial design meets the requirements of a new drug application. Citius is currently recruiting sites for a phase 3
trial of Mino-Lok in the United States. We believe we will begin treating patients under our phase 3 protocol by the end of
the quarter (Q4 2017).
Citius' Mino-Lok product
is expected to provide a superior alternative to removing and replacing central venous catheters (CVCs). Of the approximately 7
million CVCs used annually, about 500,000 or 7% become contaminated leading to serious, life threatening infections called catheter-related
blood stream infections (CRBSIs). If we think of 500,000 annual infections at $10,000 a visit to the catheter lab, this is billions
of dollars in annual expense caused by this problem. We see this as a potential $750 million opportunity globally. A 90 patient
Phase 2b clinical study using our Mino-Lok product demonstrated sufficient safety to proceed to a pivotal Phase 3 trial.
Our Mino-Lok product has received a U.S. FDA QIDP designation. "QIDP" stands for Qualified Infectious
Disease Product which is a designation that allows for Fast Track Status, Priority Review, and increased protection by granting
an additional 5 years of market exclusivity at the new drug application (NDA) approval.
Our Hydro-Lido is a topical formulation
of hydrocortisone and lidocaine that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from
hemorrhoids. Citius has completed Phase 2a studies for Hydro-Lido. We believe Hydro-Lido could become the first FDA-approved
product to treat hemorrhoids in the United States. We are preparing for a Type C meeting with the FDA to discuss upcoming phase
A common healthcare concern in the United
States is hemorrhoids. This condition afflicts nearly 5% of the population, with approximately 10 million patients annually reporting
symptoms of hemorrhoid disease. By age 50, approximately half of adults will have suffered from the pain and discomfort caused
by hemorrhoids. Approximately one-third visit a physician for evaluation and treatment of their hemorrhoids.
Well-Capitalized for Future Growth
To date, we have successfully
raised $26.8 million, often with the help of insiders and management. In August, we announced a raise of $6.8 million at $4.125
per share. Our ability to successfully raise capital for the growth of our company is significant advantage to us as an emerging
growth medical technology company.
Addition of South America To Our World License
In March, we announced we added South America
to our worldwide license for Mino-Lok . South America was the only territory that was not included in the original sub-license
between Novel Anti-Infective Technologies, LLC, an affiliate of MD Anderson Cancer Center ("MDACC"), and Leonard-Meron
Biosciences, Inc. ("LMB"), a wholly owned subsidiary of Citius Pharmaceuticals, Inc.
Addressing an Urgent Threat
Earlier this year, we were encouraged by the
work performed by the MDACC that showed Mino-Lok to be highly effective in vitro against highly virulent organisms that
form biofilm to protect their colonies from antibiotic attack.
During the first quarter of 2017, we
announced a survey of 31 physicians clearly showing a need for catheter salvage in patients with indwelling central venous lines,
especially when the catheter is a tunneled or an implanted port. There were 19 Infectious Disease experts and 12 Intensivists
surveyed who all agreed that salvage would be preferable to catheter exchange fearing that catheter misplacements, blood clots,
or vessel punctures can potentially occur during reinsertion. Most were also concerned that viable venous access may not be available.
Experienced Management and Board
As a founder of and an investor in this company,
I am confident in declaring that we have one of the most impressive collections of talent that I have ever seen at one startup
company. Prior to joining Citius our Executive Chairman and my partner, Leonard Mazur, was the co-founder and Vice Chairman of
Akrimax Pharmaceuticals, LLC, a company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was
founded in September 2008 and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical
companies. Before Akrimax, Leonard served as CEO of Genesis Pharmaceutical, Inc. a dermatological products company that marketed its
products through dermatologists' offices as well as co-promoting products for major pharmaceutical companies. In 2003, that
business was also successfully sold to Pierre Fabre, a leading pharmaceutical company.
My background includes extensive experience
in managing and leading both large and emerging pharmaceutical and life sciences companies. Perhaps the most relevant role, was
as the President of Roche Laboratories, Inc., a major research-based pharmaceutical company. As President of Roche, I worked to
transform Roche Labs into a leading antibiotic and biotechnology company. I also co-founded Emron, Inc., a health economics and
managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP). I've also served on the
Board of Directors for Assembly Biosciences, Inc. a virology and microbiome company; BioScrip, Inc., a national home infusion company;
and, bioAffinity, a cancer diagnostics company.
Our goal in launching Citius was to build a
successful pharmaceutical company through the development and commercialization of low-risk, innovative, efficacious and cost-effective
products that address compelling market opportunities. We seek to achieve our business objectives by utilizing the U.S. Food and
Drug Administration's, or FDA's, 505(b)(2) pathway for our new drug approvals. We believe this pathway is faster, has lower risk
and is less expensive than the FDA's traditional new drug approval pathway.
In addition to focusing on new drug approvals,
we emphasize obtaining intellectual property protection. By creatively using previously approved drugs with substantial safety
and efficacy data already available, we reduce the risks associated with new chemical entity product development. Our first development
candidate was Hydro-Lido, a topical cream product containing both hydrocortisone and lidocaine for the treatment of mild to moderate
Today, Citius' management backgrounds
cover everything from product development to sales and marketing to navigating the complex public marketplace. I am confident that
our longstanding industry relationships and strategic expertise will prove invaluable to our company as we continue to leverage
the many opportunities that lay ahead of us.
On behalf of the entire Citius team and our
Board of Directors, I would like to thank our loyal shareholders for their continued support in the Company. I want to reemphasize
my confidence in both the progress that Citius has made, and the direction in which it is headed. I am bullish on our future progress
and confident that we are strongly-positioned to capitalize the many prospects that are available to us. Management believes that
our listing on the Nasdaq coupled with our fortified cash position have provided a strong foundation for near term advancements
and sustained growth. We expect to announce additional operational highlights during the fourth quarter of 2017, as we remain committed
to our primary objective of enhancing overall shareholder value.