About Citius Pharmaceuticals

Company Overview

Citius Pharmaceuticals (NASDAQ: CTXR) is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets. Citius is currently advancing two proprietary product candidates, our Mino-Lok™ product and a hydrocortisone-lidocaine formulation. Citius believes the markets for its products are large and underserved by the current standard of care.

Highlights
  • Target large market opportunities that have unmet medical needs with cost-effective products; high growth categories with low developmental risk.
  • Mino-Lok™ product is advancing to Phase 3 clinical studies.
  • Positive results from a Phase 2a study for hydrocortisone-lidocaine formulation for Grade I and II hemorrhoids.
  • Experienced management team with demonstrated success developing and commercializing novel pharmaceutical products.

Citius Leadership Rings the NASDAQ Opening Bell to Celebrate Successful Up-Listing (Photography by Christopher Galluzzo / Nasdaq, Inc.)

Development and Commercialization Strategy

Citius seeks to build a successful pharmaceutical company through the development and commercialization of innovative, efficacious, and cost-effective products that address compelling market opportunities. Citius seeks to leverage the FDA’s 505(b)(2) pathway for new drug approvals and bring products to market faster and with less cost as compared to other FDA new drug approval pathways.

Development and Commercialization Objectives
  • Identify later stage drug candidates that can be developed within a 3-4 year time horizon using a 505(b)(2) pathway.
  • License the most relevant and advanced technologies to provide superior product characteristics and intellectual property protection for 10 years.
  • Focus on therapeutic areas that are highly influenced by key opinion leaders (KOLs) and drugs that are prescribed by a relatively small number of physicians.
  • Provide cost-effective therapies that would be endorsed by patients, providers, and payers.
FDA’s 505(b)(2) Approval Pathway

The 505(b)(2) approval pathway was introduced by the FDA to encourage innovation while eliminating costly and time-consuming duplicative pre-clinical studies.

There are compelling commercial benefits to employing the 505(b)(2) regulatory strategy, including the availability of three years of market exclusivity. Depending on the extent of the changes to the previously approved drug and the type of clinical data included in the NDA, the FDA may also grant other forms of exclusivity and orphan drug status.

Mino-Lok™

Our Mino-Lok™ product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (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.

Our Mino-Lok™ product is intended to salvage the CVC obviating the need to remove and replace the catheter. This is a recognized unmet medical need. There are 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. Learn more about Mino-Lok >>

Program Highlights
  • Partnership with a leading cancer center and support from key industry opinion leaders.
  • In a Phase 2b trial, our 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.

Our Mino-Lok™ product was developed by clinicians and technologists at the M.D. Anderson Cancer Center. Citius obtained a worldwide license to the patented technology (with the exception of South America) in May 2014. In March 2016 Citius announced that it has recently concluded negotiations to add South America to its worldwide license for Mino-Lok™. South America was the only territory that was not included in the original sub-license.

Hydro-Lido

Citius is developing a topical formulation of hydrocortisone (3%) and lidocaine (5%), Hydro-Lido, to provide anti-inflammatory and anesthetic relief to patients suffering from Grade I and II hemorrhoids.

Although there are numerous prescription and over-the-counter 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. Citius has recently completed a Phase 2a clinical study in 211 hemorrhoid patients. Learn more about Citius’ Hemorrhoids Program >>

Commercial Opportunity
  • By age 50, approximately half of adults will have suffered from the pain, bleeding, itching and discomfort caused by hemorrhoids.
  • In the United States., hemorrhoids affect nearly 5% of the population, with approximately 10 million persons annually reporting symptoms of hemorrhoidal disease; of these patients, approximately one-third visit a physician for evaluation and treatment.
  • We believe Citius’ hydrocortisone and lidocaine formulation could become the first FDA-approved product to treat hemorrhoids in the United States.

Citius’ leadership team includes senior pharmaceutical company executives with successful accomplishments in advancing clinical assets and commercialization of pharmaceutical products, and experience in building shareholder value.

Leonard Mazur

Chairman of the Board

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.

Myron Holubiak

President and Chief Executive Officer

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.

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.

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.

Alan Lader, Ph.D.

VP, Clinical Operations

Dr. Lader has served as VP, Clinical Operations since March of 2016. Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr. Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital where he taught Integrated Human Physiology, and was Principal Investigator for NIH funded studies in mechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer reviewed journals and has presented more than 20 abstracts in scientific meetings. He received his Ph.D. from University of South Carolina School of Medicine. He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University.

Andrew Scott

VP, Corporate Development

Mr. Scott has 20 years of transactional experience in strategic planning, product identification, asset acquisition, and capital markets communication. He is a senior investment banker providing M&A and capital market services to several emerging biotech and pharma companies.