Today we take a look at Citius Pharmaceuticals, Inc. The company was founded in 2007 and located in Cranford, New Jersey.
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, Mino-Lok™, and a hydrocortisone-lidocaine formulation.
Citius believes the markets for its products are large and underserved by the current standard of care. 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.
The company’s 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. This innovative 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.
Citius is also 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.
With its Mino-Lok™ product the company is meeting an important need in developing an alternative to the current standard of care for catheter-related bloodstream infections. It is estimated that 7 million patients annually have the need for CVC’s, and of those, nearly 500,000 become infected. These infections can lead to serious, life-threatening complications for the patient. The main standard of care once a patient contracts an infection primarily consists of replacing and relocating the CVC. Not only are these procedures costly and uncomfortable for the patient, 15-20% of these procedures are associated with significant morbidity. Most importantly to Citius, there are currently no approved therapies to replace the current standard of care.
Additionally, Citius is currently developing a proprietary formula consisting of hydrocortisone and lidocaine (Hydro-Lido) designed for patients suffering from Grade I and II hemorrhoids. Although there are over the counter products and prescriptions commonly used to treat hemorrhoids, none of these products have gone through the clinical trial process, meaning, they do not possess any safety or efficacy data. Citius aims to be the first to market a product for this condition where the physician can provide their patients with a hemorrhoid solution approved by the FDA that has demonstrated safety and efficacy.
ON THE FAST TRACK
On October 31 Citius Pharmaceuticals received coveted “Fast Track” status for Mino-Lok™. This designation provides Citius with more frequent meetings with the FDA which ultimately leads to priority review for the company’s product. Simply stated, this “Fast Track” status enables Citius to get its product to market much more quickly than the normal process would allow, this is an obvious advantage for the company.
Additionally, back in October of 2015, the company received the Qualified Infectious Disease Product designation (QIDP). This means that along with fast-track status, its product is eligible for FDA incentives which include an additional 5 years of market exclusivity bringing the combined total to 10 years regardless of patent protection. Citius is currently in the process of setting up phase 3 trials for Mino-Lok™.
In phase 2b studies, Mino-Lok™ salvaged 100% of CVC’s helping to cure all of the bacteremias with no serious adverse events. This compares with an adverse event rate of 18% in patients receiving the current standard of care. With no approved therapies on the market for infected CVC’s, Citius is proving its therapy to be effective and is in prime position to capitalize on a potential $750 million sector in the United States alone.
Additionally, with its Hydro-Lido product completing phase 2a studies, the company is putting itself in position to be the only FDA approved hemorrhoid treatment on the market. It is believed that by age 50, about half of adults have suffered from hemorrhoid related symptoms. Furthermore, IMS data shows over 25 million units of topical combination prescriptions were sold in the US comprising an estimated $80 million annual market for Citius to dip into. Should the company continue to execute on its development strategies
and bring its innovative products to market; early investors can reap significant rewards.