Home Run Investments Has Uncovered Another Potential Home Run For Our Members

All Bio-Pharma Stocks Are NOT Created Equal
We are always looking for "Firsts/no competition" in Health Care. Check Out Upcoming Catalysts for Citius Pharmaceuticals, Inc. and why an investment today has the potential to create a future return you can brag about.

Description: Citius Pharmaceuticals
Citius Pharmaceuticals, Inc. (OTCQB: CTXR)

Why we believe CTXR is on the verge of a substantial breakout…

  • Recent company news states an up-list from the OTCQB to the NASDAQ
  • New technology to treat a hard to treat and deadly medical condition
  • New and Improved version of a widely used OTC drug
  • There are only 5 million shares outstanding
  • Estimated 1.5 Million free trading shares (float, as of June 14, 2017)
  • Over $10 million invested by the company founders; $5 million in public funds; the founders and management have "skin in the game"
  • Strategic portfolio of later-stage drug products with limited development risk
  • Multiple near-term milestones
  • CEO is the former President of Roche Laboratories (Roche Holding AG, VTX: ROG) $253.10/share, (OTCQX: RHHBY) $32.43/share

The Path to a NASDAQ Listing

On Friday June 9, 2017 Citius completed a 15 for 1 reverse stock split which reduced the number of outstanding shares of the Company's common stock from approximately 75.8 million shares to approximately 5.05 million shares.  Management is seeking to secure a listing on the NASDAQ exchange. The NASDAQ exchange listing will allow Citius to attract a broader range of investors and to increase share liquidity.

CTXR shares may explode with a NASDAQ up-listing by attracting institutional investors, funds, and brokers to this little-known pharma gem.

In the following video from ceolive.tv watch Citius CEO, and former president of Roche Laboratories, Inc., Myron Holubiak discuss his background and the formation of the new Citius. Hear how Mino-Lok came to be, and a description of its Phase III clinical trial. Holubiak also looks to the future of developing cost effective medical products and talks about two new Phase II ready products coming in 2017.

Citius Moves Forward with Mino-Lok™ Phase 3 Trial
The short video below is a report by Small Cap Nation and details the Mino-Lok product and the current Phase III trial.

Mino-Lok CTXR
The short video below gives details, and highlights, the Mino-Lok product and Phase III developments.

Products Coming from Citius

(Note* We believe Mino-Lok is the one in the pipeline that will put Citius on the map)
The Company primarily utilizes the U.S. Food and Drug Administration’s (FDA’s), 505(b)(2) pathway for new drug approvals. Citius believes this pathway is comparatively faster, lower risk and less expensive than other new drug approval pathways. By using previously approved drugs with substantial safety and efficacy data, Citius seeks to reduce the risks associated with product development. Citius is advancing 2 product candidates - Mino-LokTM is entering Phase 3 trials, and a Corticosteroid/Lidocaine formulation is entering Phase 2b.

CTXR | Potential $500 Million - $1 Billion Product Entering Phase 3 Trials


Mino-Lok: About 7 million Central Venous Catheters (CVCs) are used annually, and approximately 7% become contaminated leading to serious, life threatening infections called catheter-related blood stream infections (CRBSIs). The standard of care in the management of CRBSIs consists of removing the infected CVC and replacing it with a new catheter at a different vascular access site.

Some studies suggest that the current standard care for CRBSIs can cost up to $50,000.
The simple math presented above (500,000 CVC replacements x $50,000 each) means the medical community may currently be spending $25 Billion annually treating CRBSIs

The Mino-Lok™ product is an antibiotic lock solution used to treat patients with CRBSIs. CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge.

Mino-Lok™ is intended to salvage the CVC eliminating the need to remove and replace the catheter.This is a recognized unmet medical need. There are currently no alternatives other than the removal and reinsertion of the CVC once the CVC becomes infected. Studies show that removal and reinsertion of CVCs have a 15 to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.

Mino-Lok™ contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. The Mino-Lok™ product is used in two-hour locking cycles allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.

Central Venous Catheter

Certain patient populations are at particularly high risk for complications resulting from CRBSIs, including: Cancer and hemodialysis patients with long-term surgically implantable silicone catheters. Removal of the CVC and reinsertion of a new one at a different site may be difficult, or even impossible, because of the unavailability of other accessible vascular sites and the need to maintain infusion therapy. Critically ill patients with short-term catheters that have underlying coagulopathy, where the blood’s ability to clot is impaired. This condition makes reinsertion of a new CVC at a different site risky in terms of mechanical complications, such as hemopneumothorax, misplacement, or arterial puncture.

Clinical Data: Citius completed a Phase 2b study in December 2014. There were 90 patients in the study, with 30 patients in the active arm and 60 patients in a matched cohort for comparison. All patients were receiving treatment at M.D. Anderson Cancer Center for hematologic or solid tumor cancers.

Outstanding Comparative Results: The Mino-Lok™ product salvaged 100% of CVCs, helping to cure all the bacteremias with no serious adverse events, compared to an 18% serious adverse event rate in the matched cohort where patients had the infected CVCs removed and replaced with a new CVC.

Mino-Lok Program Highlights

  • Partnership with a leading cancer center and support from key industry opinion leaders.
  • In a Phase 2b trial, the Mino-Lok™ product demonstrated a 100% efficacy rate in salvaging infected CVCs; the Mino-Lok™ product had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
  • FDA QIDP designation and patent protected until June 2024.
  • Advancing to a Phase 3 pivotal superiority trial.

 

QIDP Designation: The Qualified Infectious Disease Product (QIDP) designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that the Mino-Lok™ product is eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

Phase 3 Study: Based on Phase 2b results, Citius believes that the Mino-Lok™ product is highly effective in salvaging infected indwelling catheters and is well tolerated, making Mino-Lok™ therapy an attractive alternative to removing and re-inserting a new CVC. Citius plans to conduct a Phase 3, multi-center, randomized, double blind, placebo- and active- controlled study in 700 patients. Citius believes that the Mino-Lok™ product’s NDA can be approved within two and one-half years based on the current development plan.

There are currently no approved therapies to salvage infected CVCs,
which makes the market for CTXR's Mino-Lok alternative enormous and exclusive!

Most importantly, Mino-Lok serves a critical medical need and could save many lives.


Hydro-Lido Potential Market is over 4 Million Prescriptions and more than $1 Billion

Hydro-Lido: Citius is developing a proprietary topical formulation of hydrocortisone (3%) and lidocaine (5%) to provide anti-inflammatory and anesthetic relief to persons suffering from Grade I and II hemorrhoids. Although there are numerous prescription and over-the-counter (OTC) products commonly used to treat hemorrhoids, none currently possess safety and efficacy data generated from rigorously conducted clinical trials. Citius believes its hydrocortisone-lidocaine product will become an important treatment option for physicians who want to provide their patients with a therapy that has demonstrated safety and efficacy in treating hemorrhoids, an uncomfortable and often recurring condition.

Hydro-Lido could become the first FDA-approved product to treat hemorrhoids in the United States. According to IMS, over 25 million units of topical combination prescription products for hemorrhoids were sold in the United States. during the twelve-month period ended June 2012, comprising an estimated $80 million annual market. This product would be the only FDA approved prescription therapy for hemorrhoids. The potential market is over 4 million prescriptions and more than $1 billion.

Targeted Acquisitions: Citius is actively seeking business development focused on adjunctive cancer care (infection, chronic pain, nausea, etc.). This is a fast-growing segment with exceptional opportunities.

Links to Recent News From Citius

Significant Patent News

On June 20, 2017 Citius announced it received notification from MD Anderson Cancer Center that US Patent Application (US 2017/0151373 A1) has been published by the US Patent Office, date of publication June 1, 2017: the application was originally filed on November 4, 2016. The patent invention overcomes limitations in mixing antimicrobial solutions in which components may precipitate because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. Citius holds the exclusive worldwide license which provides access to this patented technology for development and commercialization of Mino-Lok.
https://finance.yahoo.com/news/citius-pharmaceuticals-announces-us-patent-110000201.html

Management is a Key Factor when our Team Identifies the Next Home Run for our Members

"The Citius Pharmaceutical Team Has to be the Most Impressive and Accomplished We Have Ever Seen on a Stock Trading Under $10/share."

The success of any enterprise has many factors, but none as important as the people running the organization. Citius has assembled a team of pharma “stars” to accomplish their mission. Take the time to read these profiles. This management team is the reason Citius will be a successful company, and a sound investment.

Former President of Roche Laboratories, Inc. a subsidiary of Hoffmann-La Roche Inc. (Roche Holding AG, VTX: ROG) $253.10/share, (OTCQX: RHHBY) $32.43/share

Myron Holubiak, President and Chief Executive Officer, Director:  Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard Meron Biosciences, Inc. prior to its merger with Citius in March 2016. Mr. Holubiak was the President of Roche Laboratories, Inc. (“Roche”), a major research-based pharmaceutical company, from December 1998 to August 2001. Prior to that, he held sales and marketing positions at Roche during his 19-year tenure. During his tenure as President of Roche, Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. He was also founder of Emron, Inc., a health economics and managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP). Mr. Holubiak was also a director of Bioscrip, Inc., a national home infusion company, from 2002 through 2016, and served as Chairman of the Board from 2012 through 2016. Since July 2010, Mr. Holubiak has served as a member of the board of directors of Assembly Biosciences, Inc. (“Assembly”) and its predecessor Ventrus Biosciences, Inc. Mr. Holubiak is also a trustee of the Academy of Managed Care Pharmacy Foundation. He received a BS in Molecular Biology and Biophysics from the University of Pittsburgh; he received advanced business training from the Harvard Business School and the University of London; and, advanced training in health economics from the University of York’s Centre for Health Economics.

Founder of Akrimax, Triax and Genesis, pharmaceutical companies

Leonard Mazur, Chairman of the Board, Director: Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building, and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical 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. From January 2005 to May 2012, Mr. Mazur also co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC (“Triax”), a specialty pharmaceutical company producing prescription dermatological drugs. Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc. (“Genesis”), a dermatological products company that marketed its products through dermatologists’ offices as well as co-promoting products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company.

Mr. Mazur has extensive sales, marketing, and business development experience from his tenures at Medicis Pharmaceutical Corporation, as executive vice president, ICN Pharmaceuticals, Inc. as Vice President, Sales & Marketing, Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc. Mr. Mazur is a member of the Board of Trustees of Manor College and is a recipient of the Ellis Island Medal of Honor. Mr. Mazur received both his BA and MBA from Temple University and has served in the U.S. Marine Corps Reserves.

Founder and EVP for Reliant Pharmaceuticals, LLC;
later sold to GlaxoSmithKline plc. (NYSE: GSX) $43.34/share

Gary F. Talarico, EVP, Operations: Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently he was a founder, partner, and Executive Vice President of Leonard Meron Biosciences; he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talarico was a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included Vice President of Sales for Medicis Pharmaceutical at its initial start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.

Lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc. (NYSE: VRX) $13.21/share

Jaime Bartushak, Chief Financial Officer: Mr. Bartushak is an experienced finance professional for early stage pharmaceutical companies, and has over 20 years of corporate finance, business development, restructuring, and strategic planning experience. Most recently in 2014, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc. Mr. Bartushak is also one of the founders of Leonard-Meron Biosciences and was instrumental in their startup as well as obtaining initial investment capital.


Summary

We’ve presented the Citius Pharmaceutical story to you; the products (Mino-Lok with a huge market potential and no competition), the team (Pharma All-Stars), the clinical trials (Phase III with great efficacy results thus far). Now may be the time to act.

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Please visit the Citius Pharmaceutical corporate website for a complete Company Presentation, product information, and a Corporate Fact Sheet.

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