Shots:
- Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma
- In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape
- Leonard also highlights Mino-Lok, Citius’ innovative antibiotic lock solution designed to combat catheter-related and central line-associated bloodstream infections (CRBSIs & CLABSIs)
Saurabh: What inspired your personal investment and commitment to Citius Pharmaceuticals’ mission in critical care treatment?
Leonard: My decision to co-found and invest in Citius reflects both a personal and professional mission. Over my long career in biopharma, including leadership roles and successful exits at several public and private companies, I’ve seen the urgent need for innovation in underserved areas like oncology and infection management. We’re targeting real gaps in care with the potential to deliver high-impact therapies, and I’m deeply committed to seeing that mission through.
Saurabh: Lymphir is your first FDA-approved drug. Can you walk us through the significance of this approval for both the company and patients with cutaneous T-cell lymphoma?
Leonard: The FDA approval of LYMPHIR was a watershed moment for Citius. It marks our transition from a development-stage biotech to a commercial-stage company. For patients with relapsed or refractory cutaneous T-cell lymphoma, it introduces a novel, IL-2 receptor-targeted immunotherapy with a differentiated mechanism of action. It’s the first new systemic option for CTCL since 2018, offering rapid relief from skin-related symptoms and improved quality of life. For Citius, it affirms the strength of our development capabilities and unlocks new value as we enter the commercial arena.
Saurabh: What steps are you taking to ensure a successful commercial launch of Lymphir, and also, what’s your long-term vision for Citius Pharmaceuticals beyond the launch of Lymphir?
Leonard: We’ve adopted a lean, high-impact commercialization strategy that prioritizes selecting the right partners across distribution, reimbursement, and medical engagement. By leveraging external expertise and infrastructure, we’ve built a launch platform that punches well above our weight class. We’re executing with focus and efficiency, ensuring LYMPHIR reaches the right patients quickly. Long-term, our goal is to build Citius into a multi-asset biopharmaceutical company with a focus on high-value indications in oncology and critical care.
Saurabh: How do regulatory feedback and collaboration with the FDA shape your development and launch strategies?
Leonard: Close collaboration with the FDA is foundational to our approach. Constructive regulatory engagement has informed the design and execution of our pivotal trials and supported clarity on endpoints, safety expectations, and approval pathways. These interactions help us align development with regulatory expectations and proactively plan for launch, labeling, and post-marketing obligations. In so doing, we are able to focus on reducing risk while accelerating time to market.
Saurabh: Mino-Lok recently met its primary and secondary endpoints in a pivotal Phase 3 trial. What does this milestone mean for the future of infection management in cancer care?
Leonard: While not yet FDA-approved, Mino-Lok’s Phase 3 results are highly encouraging and point to its potential as a first-in-class therapy to salvage infected catheters for patients with catheter-related bloodstream infections. These infections are far too common in oncology and other chronic care settings and can lead to serious complications. If approved, Mino-Lok could offer a non-surgical alternative to catheter removal, addressing a critical unmet need and potentially improving outcomes for a broad patient population vulnerable to CLABSI.
Saurabh: Can you share more about how Mino-Lok differs from current standards of care for catheter-related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs)?
Leonard: Unlike the current standard of care, which often involves removing and replacing the infected catheter, Mino-Lok is designed to salvage the catheter in place using a combination of minocycline, EDTA, and ethanol to penetrate biofilm and eradicate pathogens. Positive safety and efficacy results of our Phase 3 clinical trial point to a potentially meaningful treatment for colonized catheters, if ultimately approved. Mino-Lok holds the potential to reduce patient risk, preserve critical venous access, and lower healthcare costs associated with catheter replacement.
About the Author:
Leonard Mazur
Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable success in founding and building multiple healthcare companies and creating value and returns for investors throughout his five-decade career. Mr. Mazur was the co-founder and Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He was previously the co-founder and Vice Chairman of Akrimax Pharmaceuticals, LLC, which specialized in cardiovascular and general pharmaceutical products.
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