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Leonard Mazur brings a wealth of pharma experience—both big and small—to his current position of executive chairman of Citius Pharmaceuticals, where he’s helping to develop a pipeline of critical care products. Here, he talks about his commitment to drug development and what it takes to succeed in the industry today.
Pharm Exec: After a full career in pharma, what drew you to the development of critical care products?
Mazur: I spent much of my career as a serial entrepreneur bringing prescription products to market. Prior to founding Citius, I had the opportunity to acquire the rights to minocycline, an antibiotic that works effectively to treat acne. Minocycline was available in pill form, although it had previously been available in an IV formulation.
One day, I received a call from the Department of Defense, asking if we could provide them with minocycline in an IV solution. My partner and I explored how we might fulfill the request and ultimately determined that it would not be a profitable venture. However, as a former Marine reservist, I answered the patriotic call of duty and we produced an IV solution of minocycline. At the time, all we could afford were two sales reps for the product.
Once we began marketing the IV minocycline, we noticed that there was a large concentration of sales from The University of Texas MD Andersen Cancer Center. Upon further exploration, we found that Issam Raad, MD, a world-renowned infectious disease specialist, was using it in his research on intravenous catheter infections. We were intrigued and ultimately funded the early research of what is now Citius’ late Phase III product candidate, Mino-Lok, potentially the first and only solution to treat central venous catheters colonized by bacteria. Mino-Lok became the first critical care product in the Citius pipeline.
Pharm Exec: What does it take to build a strong, experienced team in pharma?
Mazur: I’ve been fortunate in my many years in the industry to have worked in both large and small pharmaceutical companies. The best teams are invariably the ones that stay focused on a common goal and in which each team member brings a unique skill set to his or her role.
In pharma, experience matters, and by that I don’t just mean successes. There are so many potential issues in the drug development and commercialization processes; often it is individuals with experience responding to regulatory delays, manufacturing challenges, or commercial hiccups, who can provide the most insight to a team.
And importantly, successful execution relies largely on the ability of team members to communicate openly and respectfully with each other. This is especially true in smaller organizations, like Citius, where we have been fortunate to expand our team with individuals who are subject matter experts in their respective fields.
Pharm Exec: How do you wish to change the current landscape of the areas you're involved in?
Mazur: Citius’ current pipeline consists of first-in-class critical care products, with a pipeline of anti-infectives in adjunct cancer care, oncology, stem cell therapy, and unique prescription products. Each of our product candidates are intended to improve a patient’s quality of life, and in some cases extend a patient’s life.
Three of our investigational drugs would be the first and only products in their categories, filling an unmet need in the marketplace. The latest addition to our portfolio is a new formulation of a previously approved anticancer agent for an orphan indication in cutaneous t-cell lymphoma (CTCL). The current treatment options often have limited activity or significant side effects. We believe our product, if approved by FDA, will be an important addition to the treatment paradigm for this orphan disease.
Pharm Exec: What are the greatest challenges you face and how do you plan to overcome them?
Mazur: For the past two years, COVID-19 has been a significant challenge for us. Our Phase III Mino-Lok trial is being conducted in a hospital setting. And, with each COVID wave, we’ve seen hospitals limit visitation, pause non-COVID clinical research, reallocate resources, and generally succumb to staff burnout. Completion of our trial has been delayed as a result.
But we believe that we are turning the page on COVID. We are encouraged that restrictions at hospitals are easing and COVID infections are declining. We look forward to completing the trial later this year.
Pharm Exec: The founders of Citius are of Ukrainian descent. Could you speak to the effects of the current conflict on research and development there and what it could mean globally?
Mazur: The entire Citius family stands in solidarity with the people of Ukraine and condemns the Russian assault on an independent democratic nation. Myron Holubiak, Citius’ CEO, and I, as well as several members of our Board of Directors and management team, are of Ukrainian descent, with enduring ties to the Ukrainian community. As the tragic events in Ukraine unfold, the humanitarian crisis grows exponentially.
Obviously, clinical trials in Ukraine cannot be conducted while the war is active. Should the conflict broaden to other parts of Europe, it could have a more enduring impact on the scientific community and its ability to continue research and development activities. It is worth noting that progress, including scientific discovery, is made possible by the ability of free people, living in peace, to exercise the values and rights inherent in democratic societies. We hope the war in Ukraine comes to a swift conclusion.