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.
- 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.
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.
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 >>
- 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.
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 >>
- 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.